GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 2403-88-5
Chemical Name 2,2,6,6-Tetramethylpiperidin-4-ol
Substance ID 25A0050
Classification year (FY) FY2013
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance by the Japanese Government (July, 2013)
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
-
-
- - Solid (GHS definition)
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 solid 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 > 130 deg C (IUCLID (2000)).
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
P264
P270
P330
P501
There are three reports on LD50 values for rats of 1,482 mg/kg (males), 1,564 mg/kg (females) (OECD TG 401) (JECDB (Access on October 2013), SIDS (2004)), > 2,000 mg/kg (SIDS (2004)), and 2,413 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011), SIDS (2004)). Most data correspond to "Not classified," but it was classified in Category 4 by giving priority to the report on the test according to OECD TG 401 by expert judgment.
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" based on a report on an LD50 value of > 2,000 mg/kg (males and females) for rats (SIDS (2004)).
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 Category 1


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
It was classified in Category 1 because it is described that a skin irritation test with rabbits (OECD TG 404) resulted in severe irritation (SIDS (2003)), and one of the animals did not recover even after 14 days (SIDS (2003)).
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Classification not possible due to lack of data.
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
In a test with guinea pigs (OECD TG 406) (SIDS (2001)), the result of a positive rate of 69% at 48 hours after the start of the challenge and being a skin sensitizer was obtained (SIDS (2004)). Therefore, it was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. As for in vivo, it was negative in a micronucleus test with rat bone marrow cells (SIDS (2004)). As for in vitro, it was negative in a bacterial reverse mutation test, and a chromosomal aberration test with cultured mammalian cells gave an equivocal result (SIDS (2004), JECDB (Access on October 2013), IUCLID (2000)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats in the oral route (gavage), prolongation of the estrus cycle was observed at the dose where females showed general toxicity including death (1/12 animals). And decreased body weights and decreased viability on day 4 of lactation were observed in offspring (JECDB (Access on October 2013), SIDS (2004), Environmental Risk Assessment for Chemical Substances vol. 9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). Therefore, it was classified in Category 2. Besides, sufficient reports on developmental toxicity were not obtained.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
It is reported that in oral administration test with rats (590-2,197 mg/kg), decreased locomotor activity, mydriasis, blepharoptosis, prone position, tremors, hypothermia, piloerection, abdominal distension, emaciation, pallor of auricles, etc. were observed, but most of decreased locomotor activity, mydriasis, and blepharoptosis were reversible (SIDS (2004), JECDB (Access on October 2013)). Therefore, it was classified in Category 3 (narcotic effects). Besides, it is reported that in a dermal administration test with rats, at the upper limit concentration of the guidance value range (2,000 mg/kg), the animals showed piloerection and hunched posture but recovered later (SIDS (2004)).
9 Specific target organ toxicity - Repeated exposure Category 2 (nervous system)


Warning
H373 P260
P314
P501
It was classified in Category 2 (nervous system) because it is described that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats by gavage administration, mydriasis and blepharoptosis were observed at the dose (32 mg/kg/day (converted guidance value)) corresponding to Category 2 (SIDS (2004)).
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) Not classified
-
-
- - From 72-hour ErC50 = 120 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)), 48-hour EC50 = 100.1 mg/L for crustacea (Daphnia magna) (SIDS, 2004), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)), it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - If chronic toxicity data are used, then it is classified as "Not classified" due to 21-day NOEC (reproduction) = 3.7 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997); SIDS, 2004) although it is not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2001; SIDS, 2004)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to being not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2001; SIDS, 2004)), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)).
From the above results, it was classified as "Not classified."
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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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