GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 75-91-2
Chemical Name tert-Butyl hydroperoxide
Substance ID H29-B-058
Classification year (FY) FY2017
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 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 (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 Classification not possible
-
-
- - Although there is a chemical group associated with explosive properties (neighboring oxygen atoms) in the molecule, and oxygen balance of -195 is above the criteria, -200, the classification is not possible due to no information on onset temperature and decomposition energy. Besides, it is estimated that one containing 79-90% does not correspond to explosives because it is classified in Organic peroxide type C in UNRTDG (UN 3103).
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Liquid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Liquid (GHS definition)
6 Flammable liquids Category 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
From a flash point data of 26 deg C (unknown method) (GESTIS (Access on June 2017)), it is estimated that it corresponds to Category 2 or Category 3 in the prescribed test method, and it was classified in Category 2 from the viewpoint of safety.
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not applicable
-
-
- - One containing 79-90% is classified in Organic peroxide in UNRTDG (UN 3103, Division 5.2, type C).
9 Pyrophoric liquids Classification not possible
-
-
- - No data available.
10 Pyrophoric solids Not applicable
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid 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 Classification not possible
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen. However, the classification is not possible due to no data.
14 Oxidizing solids Not applicable
-
-
- - Liquid (GHS definition)
15 Organic peroxides Type C


Danger
H242 P411+P235
P210
P220
P234
P280
P410
P420
P501
One containing 79-90% is classified in Division 5.2, type C in UNRTDG (UN 3103) (UNRTDG 2.5.3.2.4).
16 Corrosive to metals Classification not possible
-
-
- - No data 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
P264
P270
P330
P501
Based on a report of an LD50 value of 560 mg/kg (SIDS (2002)) for rats, it was classified in Category 4.
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
Based on a report of an LD50 value of 628 mg/kg for rabbits (SIDS (2002)) and a report of an LD50 value of 470 mg/kg for rats (PATTY (6th, 2012)), it was classified in Category 3.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 2


Danger
H330 P304+P340
P403+P233
P260
P271
P284
P310
P320
P405
P501
Based on a report of an LC50 value of 1.8 mg/L (488 ppm) in a 4-hour inhalation exposure test with rats (PATTY (6th, 2012)), it was classified in Category 2. Besides, since the LC50 value was lower than 90% of the saturated vapor pressure concentration (7,206 ppm), a reference value in the unit of ppm was applied as vapour with little mist. The category was changed from the previous classification due to the use of a new information source.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 1


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
Based on reports that in skin irritation tests with rabbits, corrosivity or severe irritation with necrosis was observed in all of the three tests (EU-RAR (2006)), it was classified in Category 1.
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
On the basis that this substance was classified in Category 1 for skin corrosion/irritation, it was classified in Category 1. Besides, in eye irritation tests with rabbits, results showing severe irritation are reported in the multiple tests (EU-RAR (2006)).
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
Based on a description that a positive reaction of moderate to severe erythema was observed in 6 out of 10 animals in a skin sensitization test (OECD TG 406 compliant) with guinea pigs (EU-RAR (2006)), it was classified in Category 1. The category was revised based on information obtained in this investigation.
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
As for in vivo, a dominant lethal test with mice was positive, a micronucleus test with mouse bone marrow cells and a chromosomal aberration test with rat bone marrow cells were negative, and it was positive in a comet assay with hepatocytes of rats, DNA adduct formation tests with the liver and stomach of rats, and DNA damage tests with testes and epididymal sperms of rats (EU-RAR (2006)). As for in vitro, bacterial reverse mutation tests, and a mouse lymphoma test, chromosomal aberration tests and a sister chromatid exchange test with mammalian cultured cells were all positive (EU-RAR (2006), DFGOT Vol. 3 (1992), NTP DB (Access on June 2017)). Considering that the positive result in a mouse dominant lethal test is assumed to be a local effect by intraperitoneal administration, and that this substance is metabolized to non-mutagenic substance, it is unlikely that this substance which is absorbed will reach the germ cells (EU-RAR (2006)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government.
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - In a test in which rats were dosed by gavage at up to 30 mg/kg/day from 2 weeks before mating to gestational day 21 or 22 days, neither reproductive effects on parental animals nor effects on pups were observed (Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), SIDS (2002)). In addition, in a developmental toxicity test with pregnant rats dosed by gavage (gestational day 6-15), no effect was observed in the fetuses at 50 mg/kg/day where a slightly decreased body weight gain was observed in maternal animals (Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), SIDS (2002)). From the above, no reproductive effects or developmental effects were observed in the tests with rats, and it is considered to be possible to classify it as "Not classified." However, in the first test examining the effect on fertility, no general toxic effect on parental animals was observed, and the possibility that the doses were inadequate for the test to assess the reproductive effect could not be denied. Therefore, it was difficult to conclude that this substance does not cause reproductive toxicity only with these results, and it was classified as "Classification not possible" due to lack of data.
8 Specific target organ toxicity - Single exposure Category 1 (respiratory organs), Category 2 (nervous system), Category 3 (narcotic effects)



Danger
Warning
H370
H371
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
There is no information on single exposure to this substance in humans. As for experimental animals, there is a report that in a single oral administration test with rats, sedation, pallor of the skin, loss of righting reflex, lacrimation, hypothermia, and haematuria were observed at or above 420 mg/kg corresponding to Category 2 (EU-RAR (2006)). In addition, there is a report that in 4-hour inhalation exposure tests with rats and mice, irregular respiration, and hyperaemia of the lungs and haemorrhages on the lung surface at necropsy of dead cases were observed, and that LC50 values were 1.845 mg/L (500 ppm) for rats and 1.292 mg/L (350 ppm) for mice. Although there is no detailed description of the dose at which the effects were observed in these tests, it is considered that they were observed at doses which are within the range for Category 1 and near the LC50 values (EU-RAR (2006)). Moreover, there is a report that in a sensory irritation test with mice, after a 30-min inhalation exposure to this substance, a decreased breathing rate and apnoea were observed, and that an RD50 value was 20.9 ppm (0.0771 mg/L) (EU-RAR (2006)). As for the dermal route, there is a report that in a single dermal exposure test with rabbits, cyanosis, ataxia, lethargy, slow and laboured respiration, nasal discharge, congestion, prostration, nystagmus, red discharge from nares, and convulsions were observed at 1,997 mg/kg in the range of Category 2, and atonia occurred in survivors (EU-RAR (2006)). From the above information, it is considered that the nervous system and respiratory organs were regarded as target organs for this substance, and this substance has narcotic effects. Since effects on the lung and nervous system were observed at the doses corresponding to Category 1 and Category 2, respectively, it was classified in Category 1 (respiratory organs), Category 2 (nervous system), Category 3 (narcotic effects). As for the effect on the respiratory organs, since EU-RAR, the information source in List 1, was used as a new information source, the category for the respiratory organs was changed to Category 1. Besides, in the previous classification, the haemal system was also adopted as a target organ based on the description that "methemoglobinemia or carboxyhemoglobin" (RTECS (2006)). However, since there is no corresponding description in RTECS (Access on September 2017), and no other information that could be the evidence of the effect on the haemal system was obtained either, it was not adopted. Therefore, the category was changed from the previous classification.
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - No information on humans is available.
As for experimental animals, there is a report that in a 45-day repeated oral dose toxicity test with rats dosed by gavage, increased bilirubin and male rat-specific renal tubular nephritis in males at or above 10 mg/kg/day (converted guidance value: 5 mg/kg/day), a decrease in reticulocyte count in males at 30 mg/kg/day (converted guidance value: 15 mg/kg/day) were observed, but no effect was observed in females (Environmental Risk Assessment for Chemical Substances Vol.7, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2009), SIDS (2002)).
From the above, sufficient information for classification was not obtained.
By reconfirming the contents of the assessment report, the classification was changed from the previous one.
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 EC50 (rate method) = 1.1 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), 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 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 2000)), and 72-hour NOEC (rate method) = 0.14 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)).
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 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 2000)), and 48-hour EC50 (immobile) = 14 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)).
From the above results, it was classified in Category 2.
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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