GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 119-61-9
Chemical Name Benzophenone
Substance ID H28-B-12-METI, M-014B
Classification year (FY) FY2016
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2008  
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 (Ver. 1.1))
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 560 deg C (GESTIS (Access on October 2016)).
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
-
-
- -  It is a substance with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

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
P264
P270
P330
P501
 Two LD50 values of > 10,000 mg/kg (NTP TR533 (2006), NTP TOX61 (2000), JECFA FAS48 (2001), PATTY (6th, 2012)) and 1,900 mg/kg (NTP TR533 (2006), NTP TOX61 (2000)) are reported for rats. One corresponds to "Not classified," and the other corresponds to Category 4. By adopting the category with higher hazard, this substance was classified in Category 4.
1 Acute toxicity (Dermal) Not classified
-
-
- -  On the basis of a reported LD50 value of 3,535 mg/kg for rabbits (NTP TR533 (2006), NTP TOX61 (2000), PATTY (6th, 2012)), this substance was classified as "Not Classified"(Category 5 in the 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) Classification not possible
-
-
- -  Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- -  Classification not possible due to lack of data. Besides, as a result of the 24-hour application of this substance to guinea pigs under an occlusive wrap, slight erythema, desquamation, and slight-to-moderate edema were observed, therefore slight irritation is reported (PATTY (6th, 2012)). It is reported that in a test in which a 20% solution was applied to abraded rabbit skin, slight-to-medium erythema with focal necrosis and dyskeratosis were observed, and the substance was a moderate irritant from the primary cutaneous irritation index value of 2.0 (PATTY (6th, 2012)). However, neither was used for classification because neither test was conducted under conditions suitable for classification. Additionally, the information on IUCLID used for the previous classification could not be confirmed because it is not available.
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
 It was reported that, in an eye irritation test using rabbits, after the application of the crystals of this substance, slight-to-medium erythema of the conjunctiva and nictitating membrane was observed, but resolved within 14 days (PATTY (6th, 2012)). From the above, this substance was classified in Category 2B.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- -  There are several reports of skin sensitization tests. It was reported that in an open epicutaneous test, a maximization test, a Draize test, and a Freud's complete adjuvant test, there is no skin sensitization (PATTY (6th, 2012)). In addition, no skin sensitization is reported in a modified Draize test and a maximization test using guinea pigs, and a Draize test using rabbits (PATTY (6th, 2012)). Although none of the above tests complies with the guidelines, there were descriptions regarding methods of induction and challenge and the others. Therefore, it was judged that this substance could be classified as "Not classified," in a comprehensive manner.
5 Germ cell mutagenicity 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, this substance was classified as "Classification not possible." As for in vivo tests, micronucleus tests using mouse bone marrow cells and peripheral blood lymphocyte indicate negative. As for in vitro tests, a bacterial reverse mutation test indicates negative (IARC 101 (2013), NTP DB (Access on October 2016), PATTY (6th, 2012)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
 In a 2-year carcinogenicity test using rats and mice administered by feed, increased incidences of renal tubular adenoma in male rats, hepatocellular adenoma in male mice, and histiocytic sarcoma in female mice were observed (NTP TR533 (2006)). Although there is no information in humans, IARC classified this substance in Group 2B because there is sufficient information in experimental animals (IARC 101 (2013)). The Japan Society for Occupational Health also classified this substance in Group 2B (Recommendation of Occupational Exposure Limits (2016): recommended in 2015). Therefore, this substance was classified in Category 2.
7 Reproductive toxicity Not classified
-
-
- -  In a two-generation reproductive toxicity test using rats dosed by fed, at the high dose (2,000 ppm: corresponding to 130.0 - 179.2 mg/kg/day) at which the general toxic effects (suppression of body weight gain and liver/kidney weight increase, dilation and regeneration of renal proximal tubules in the kidney) are observed in F0, F1 parents, only suppression of body weight gain is observed in the F1, F2 offspring; no influence on the sexual function of the parent animals and minimum influence on the development of the next generation were observed, (the Ministry of Economy, Trade and Industry, a test result on endocrine disturbance action (year unknown)), PATTY (6th, 2012)).
 On the other hand, in developmental toxicity tests with gavage administration to pregnant rats or pregnant rabbits (rats: gestation days 6-19; rabbits: gestation days 6-29), at the high doses above the doses where maternal toxicity occurred (rats: suppression of body weight gain, lethargy, and liver and kidney weight increase; rabbits: death, suppression of body weight gain and premature delivery), in offspring, ossification delay, extra ribs and low values of weights in rats, only the low value of weight in rabbits were observed, all of which was just slight effect and cannot be used as the rationale for the classification (PATTY (6th, 2012)). Therefore, based on the results of the two-generation reproductive toxicity test in rats and a developmental toxicity test in rats and rabbits, this substance was classified as "Not Classified."
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- -  There is no data on single exposure of this substance in humans. As for experimental animals, it was reported that in a single oral administration test of mice, at 2,895 mg/kg, which exceeds Category 2, in a death case, sedation, a decrease in locomotor activity, abnormal gait, tremors, and respiratory depression were indicated, but no damage to tissues and organs were observed by necropsy (PATTY (6th, 2012)), but since this information is insufficient for classifying target organs, this substance was classified as "Classification not possible." Additionally, in the previous classification, a description in ICSC (1997) that pharyngitis is an acute toxic symptom when inhaling was cited as reference information, but it was not written in ICSC (2010).
9 Specific target organ toxicity - Repeated exposure Category 2 (liver, kidney, haemal system)


Warning
H373 P260
P314
P501
 There is no information in humans.
 As for experimental animals, in a 105-week repeated dose toxicity study using rats dosed in the feed, at or above 15 mg/kg/day, which is equivalent to Category 2, effects on the kidneys (renal tubule hyperplasia, hyperplasia of the pelvis transitional epithelium, and increased severity of nephropathy) and effects on the liver (centrilobular hepatocellular hypertrophy and bile duct hyperplasia) were observed; at 30 mg/kg/day or above, cystic degeneration in the liver was observed. In a 105-week repeated dose toxicity study using mice administered by feed, at 312 ppm (males: 40 mg/kg/day, females: 35 mg/kg/day) or higher, effects on the liver (centrilobular hepatocellular hypertrophy, multinucleated hepatocytes, and chronic active inflammation), effects on the kidney (nephropathy or increased severity of nephropathy, and mineralization), and hyperplasia of lymphoid follicles in the spleen were observed; at 625 ppm (males: 80 mg/kg/day, females: 75 mg/kg/day) or higher, cystic degeneration in the liver was observed (NTP TR533 (2006)).
 Besides, it is noted hyperplasia of lymphoid follicles in the spleen is the finding that is associated with malignant lymphoma. In addition, in male rats, secondary lesions related to nephropathy are observed in many organs, and it is noted that parathyroid gland hyperplasia and fibrous osteodystrophy in bone are also secondary lesions related to nephropathy (NTP TR533 (2006)).
 Elsewhere, it is reported that in a 14-week repeated-dose toxicity test using rats dosed in the diet, cytoplasmic vacuolization of hepatocytes and protein casts in renal tubules in the kidney were found at or above 1,250 ppm (75 mg/kg/day), which is equivalent to Category 2 (NTP TR533 (2006), PATTY (6th, 2012)), There is a report that in a 28-day repeated-dose toxicity test using rats dosed in the diet, hemolysis, general protein increase, albumin increase, weight increase of liver and kidneys, histopathological alteration of the liver at or above 100 mg/kg/day (converted guidance value: 31.1 mg/kg/day), which is equivalent to Category 2, PATTY (6th, 2012)). Therefore this substance was classified as "Category 2 (liver, kidney, haemal system)."
 Additionally, myelofibrosis noted in the previous classification was not used as evidence of classification because it was a significant change only in the most highly dosed male rats in which nephropathy was found.
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) Category 2
-
-
H401 P273
P501
 From 72-hour ErC50 = 3.53 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
 If chronic toxicity data are used, then it is classified in Category 2 because it is not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), and its 21-day NOEC = 0.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)).
 If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 because it is not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), and its 96-hour LC50 = 10.9 mg/L for fish (Pimephales promelas) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)).
 It was classified in Category 2 from the above results.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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