GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 108-46-3
Chemical Name Resorcinol (Resorcin)
Substance ID H26-B-108, -
Classification year (FY) FY2014
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2009   FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition)
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Solid (GHS definition).
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- - Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- - Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- - No data available.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition).
10 Pyrophoric solids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 607 deg C (ICSC (2003)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition).
14 Oxidizing solids Not applicable
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 4


Warning
H302 P301+P312
P362+P364
P264
P270
P330
P501
There are 6 reports of LD50 values of 202 mg/kg, 301 mg/kg, 370 mg/kg (CICAD 71 (2006)), 510 mg/kg (male/female) (SIDS (2009)), 980 mg/kg (PATTY (6th, 2012), SIDS (2009), CICAD 71 (2006), ACGIH (7th, 2001), NTP TR 403 (1992)) and 202-980 mg/kg (DFGOT vol. 20 (2003)) for rats. One value corresponded to Category 3, however, it was classified in Category 4 to which the greatest number of data (4 values) corresponded according to the GHS Classification Guidance for the Japanese Government. Besides, since 1 value is an aggregated value of multiple data, it was not included in the number of data.
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on reports of LD50 values of 2,830 mg/kg (SIDS (2009), CICAD 71 (2006)) and 3,360 mg/kg (PATTY (6th, 2012), SIDS (2009), DFGOT vol.20 (2003), ACGIH (7th. 2001), NTP TR 403 (1992)) for rabbits, it was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - Based on a report of an LC50 value (1 hour) of 21.3-78 mg/L (converted 4-hour equivalent value: 5.3-20 mg/L) for rats (IUCLID (2000)), it was classified as "Not classified." Besides, since the LC50 value was higher than the saturated vapor concentration (0.00289 mg/L), the reference value for a mist was applied.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
In a semi-occlusive application test (OECD TG 404, GLP-compliant) in which a 2.5% solution of this substance was applied to rabbits, no irritation reaction was observed, and it was judged to be not irritating (SIDS (2009)). In addition, in skin irritation tests in which this substance was applied to rabbits for 24 hours, there are reports of which skin irritation scores were 4.4 and 5.4, and scars and crust on the necrosis area were observed after 14 days (SIDS (2009), DFGOT vol.20 (2003), CICAD 71 (2006)). In addition to a report that in an epidemiological study of 268 workers, a direct relationship was observed between the occurrence of dermatitis and exposure to this substance (NTP TR403 (1992), ACGIH (7th, 2001)), multiple cases of dermatitis by exposure to this substance were reported (SIDS (2009), PATTY (6th, 2012)). Besides, this substance was classified as "Xi; R38" in the EU DSD classification, and as "Skin Irrit. 2 H315" in the EU CLP classification. From the above, although the degree of irritation was unknown, it was classified in Category 2 based on the result of the epidemiological study in humans.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
There are multiple reports of eye irritation tests with rabbits, and there are reports that irreversible conjunctivitis, iritis and corneal opacity were observed (SIDS (2009)), and that it caused irreversible ulcerations (ACGIH (7th, 2001)). In addition, there are reports that the irritation scores were 39.9-56.3 and 105 (maximum value 110), respectively (SIDS (2009), CICAD 71 (2006)). From the above results, it was classified in Category 1. Besides, this substance was classified as "Xi; R36" in the EU DSD classification, and as "Eye Irrit. 2 H315" in the EU CLP classification.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
There is a report that in a skin sensitization test (OECD TG 406, GLP-compliant) with guinea pigs, the positive rate was over 30% (SIDS (2009), DFGOT vol. 20 (2003)). In addition, both negative and positive results were obtained in mouse local lymph node assays (LLNA) (OECD TG 429) (SIDS (2009)). In humans, there are multiple reports of effects by exposure to this substance (DFGOT vol. 20 (2003), CICAD 71 (2006)), therefore, this substance was classified as "Sh" in DFGOT vol. 20 (2003). From the above results, it was judged as Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in micronucleus tests with rats and mice and a sister chromatid exchange test with rats (SIDS (2009), NTP DB (Access on October 2014), ACGIH (7th, 2001), CICAD 71 (2006), DFGOT Vol. 20 (2003), IARC 71 (1999)). As for in vitro, it was negative in bacterial reverse mutation tests, and positive results were observed in a gene mutation test (mouse lymphoma test), a chromosomal aberration test, a sister chromatid exchange test and a micronucleus test with cultured mammalian cells (SIDS (2009), ACGIH (7th, 2001), NTP DB (Access on October 2014), CICAD 71 (2006), IARC 71 (1999), DFGOT Vol. 20 (2003)).
6 Carcinogenicity Classification not possible
-
-
- - Since it was classified in Group 3 by IARC (IARC 71 (1999)) and in A4 by ACGIH (ACGIH (7th, 2001)), it was classified as "Classification not possible."
7 Reproductive toxicity Not classified
-
-
- - There is a report that in a two-generation reproductive toxicity study (OECD TG 416) with rats by the oral route (drinking water), no toxicity on fertility and pups were observed even at a dose where a decreased body weight gain was observed in maternal animals (PATTY (6th, 2012), SIDS (2009), CICAD 71 (2006)).
There is a report that in a teratogenicity test (OECD TG 414) with rats by the oral route, neither fetotoxicity nor teratogenicity was observed even at a dose where a decreased body weight gain was observed in maternal animals (SIDS (2009), CICAD 71 (2006)). In addition, there is a report that in a teratogenicity test with rabbits by the oral route, no maternal toxicity, fetotoxicity or teratogenicity was observed (PATTY (6th, 2012), CICAD 71 (2006), DFGOT Vol. 20 (2003), IARC 71 (1999), NTP TR403 (1992)).
From the above, since neither adverse effect on the fertility nor adverse effect on the development of offspring was observed, it was classified as "Not classified."
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, haemal system)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
There are multiple cases of human poisoning with this substance. Unconsciousness, tremors, convulsions, mydriasis, confusion, amnesia and disorientation after using an ointment or cream (concentration of 50% of this substance, 100 g) to treat skin diseases, methemoglobinemia, cyanosis and convulsions by oral ingestion, and burning sensation, convulsions, central nervous system disorders (dizziness, confusion, somnolence, disorientation, amnesia, tremors) and red blood cell changes (methemoglobinemia, hemolytic anemia, hemoglobinuria, cyanosis), etc. in the cases of dermal and oral poisoning in infants were observed (ACGIH (7th, 2001), CICAD 71 (2006), IARC 71 (1999), PATTY (6th, 2012), DFGOT Vol. 20 (2003)).
As for experimental animals, salivation, hyperexcitability, tachypnea, ptosis, lethargy, abnormal gait, decubitus posture, shivering, dyspnea, tremors, convulsions, sedation, tonic-clonic convulsions and cyanosis, etc. were reported by oral administration to rats (SIDS (2009), ACGIH (7th, 2001), DFGOT Vol. 20 (2003), PATTY (6th, 2012), CICAD 71 (2006)). These symptoms were observed at doses within the guidance range corresponding to Category 1.
From the above, this substance was considered to affect the central nervous system and the blood system, therefore, it was classified in Category 1 (central nervous system, blood system).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - In humans, there are many case reports of patients after dermal application of preparations containing this substance, and there are many study reports in cases by the occupational exposure in plants producing this substance, that hyperthyroidism and, in part, an enlarged thyroid occurred in workers, however, causality to exposure to this substance is not clear (SIDS (2009)) since the effects from exposure to other substances (by combined exposure to benzene or thiourea with a clear effect to inhibit thyroid function, or by ingestion of radioactive iodine for examination) cannot be excluded and the incidence is low (SIDS (2009), CICAD 71 (2006)) in reports by the occupational exposure. Other than these, as effects by exposure to this substance in humans, effects on the central nervous system and the skin disorder were reported, however, the former was considered to be an effect by acute exposure (CICAD 71 (2006)), and the latter could be judged to be due to inherent irritation from the substance.
As for experimental animals, in studies with rats and mice administered by gavage for 13 weeks, no findings suggesting specific target organs were observed within or lower than the dose ranges of Category 2, however, in studies with rats or mice administered by gavage for 2 years, ataxia, tremors and salivation were observed at doses slightly above the upper limit of Category 2 (100-112 mg/kg/day) (SIDS (2009), ACGIH (7th, 2001), CICAD (2006)). On the other hand, in a two-generation reproduction toxicity study with rats administered by drinking water, although the highest concentration of 3,000 mg/L (male: 233 mg/kg/day; female: 304-660 mg/kg/day) was administered for more than 70 days, such central nervous system symptoms were not observed, therefore, they were considered to be transient acute effects by gavage (SIDS (2009)). In addition, no tissue changes in the thyroid were observed in repeated dose toxicity studies with rats and mice. In particular, in the two-generation study with rats administered by drinking water, the effects on the thyroid hormone and tissue changes in the thyroid were rigorously examined to evaluate the effects on the thyroid in F0 parental animals, however, no effects on the thyroid were observed at up to doses exceeding Category 2 (233-304 mg/kg/day (equivalent to converted guidance value: 181-236 mg/kg/day)) (SIDS (2009), CICAD 71 (2006)). Among animal test reports listed in CICAD 71, the number of reports stating that there were thyroid effects was less than that of reports stating that there were no thyroid effects, and the former reports were from experiments with only one dose or subcutaneous injection (CICAD 71 (2006)). On the other hand, it is described in OECD SIDS that effects on the thyroid were not observed even after oral administration at up to 233-304 mg/kg/day in the two-generation study with rats, and there is a description of the mechanism of interspecies difference in which rats, unlike humans, are deficient in TBP (thyroid hormone-binding protein) and then are susceptible to thyroid hormone metabolism (short half-life of T4 in the blood) leading to being susceptible to elevation of TSH levels, and rats are more sensitive to thyroid effects than humans. And, since no effects on the thyroid were observed in the reliable two-generation study with susceptible rats, OECD SIDS is negative for effects on the thyroid in humans (SIDS (2009)).
From the above, although it was not yet possible to conclude whether there were effects on the thyroid in humans, by supporting the opinion in SIDS (2009) published after the previous classification, which expressed a negative opinion on effects on the thyroid of this substance based on interspecies differences in the endocrine mechanisms of the pituitary-thyroid system, therefore, it was judged that the "thyroid" adopted in the previous classification should be deleted from the target organ in this classification. Therefore, from the findings in experimental animals, it was considered to be corresponding to "Not classified" by the oral route, however, there was no toxicity information by the other routes, and it was classified as "Classification not possible" due to lack of data.
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) -
-
-
- - -
11 Hazardous to the aquatic environment (Long-term) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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