GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 68603-42-9
Chemical Name Coconut oil diethanolamine condensate
Substance ID H27-A-035/C-065A_P
Classification year (FY) FY2015
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 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 present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Liquids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Liquids" according to GHS definition.
6 Flammable liquids Not classified
-
-
- - A flash point is 103 degrees C (closed cup) (GESTIS (Access on July 2015)).
7 Flammable solids Not applicable
-
-
- - "Liquids" according to GHS definition.
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 Classification not possible
-
-
- - Due to no data, the classification is not possible.
10 Pyrophoric solids Not applicable
-
-
- - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible
-
-
- - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - Due to no data, the classification is not possible.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - From reported LD50 values of 12,200 mg/kg and > 5,000 mg/kg for rats (HSDB (Access on July 2015)), it was classified as "Not classified."
1 Acute toxicity (Dermal) Classification not possible
-
-
- - The classification is not possible due to lack of data.
Besides, an LD50 value of > 2,000 mg/kg for rabbits was reported for commonly distributed products of this substance (HSDB (Access on July 2015)).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
It is reported that moderate irritation was observed after 23-hour application of a 30% solution to this substance in rabbits (NTP TR 479 (2001)). Besides, as for humans, there are multiple reports of irritation by hand gel, shampoo, hydraulic oil and so on containing this substance, and it is reported that this substance was a causal substance in a patch test (NTP-TR 479 (2001), HSDB (Access on July 2015)). The substance was classified in Category 2 from the above results.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Classification not possible
-
-
- - The classification is not possible due to lack of data.
Besides, it is reported that this substance was not sensitizing in a patch test of shampoo containing 2% this substance in 104 women, (HSDB (Access on July 2015)), and that one out of 40 workers handling this substance showed a sensitization reaction in a patch test (HSDB (Access on July 2015)).
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
As for in vivo, a micronucleus test in peripheral erythrocytes of male and female mice after a 14-week dermal application was positive in both males and females (NTP TR 479 (2001), IARC 101 (2012)). As for in vitro, a bacterial reverse mutation test, a mouse lymphoma test, a chromosomal aberration test, and a sister chromatid exchange test in cultured mammalian cells were all negative (NTP TR 479 (2001), IARC 101 (2012)). From the above, although an in vivo mutagenicity test in somatic cells showed positive, there were all negative results in vitro. The substance was classified in Category 2 according to the GHS classification guidance for the Japanese government.
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
There is no usable human information on the carcinogenicity of this substance.
As for experimental animals, in a 2-year carcinogenicity test using rats or mice in a dermal route, increased incidences of the following were observed (NTP TR 479 (2001)): renal tubule adenoma or carcinoma (combined) (females only) in rats; and liver tumors (hepatocellular adenoma, hepatocellular carcinoma, hepatoblastoma) (males and females), renal tubule adenoma (alone), renal tubule adenoma or carcinoma (combined) (males) in mice. It is written in the NTP report that kidney tumors in female rats as "equivocal evidence," and it is stated in the assessment by IARC that "there is no increased incidence of tumors in a rat test." However, it is written in both NTP and IARC that increased incidences of hepatic and renal tumors in mice are clear evidence of carcinogenicity (NTP TR 479 (2001), IARC 101 (2012)).
By taking the above results into account, IARC classified the substance in Group 2B (IARC 101 (2012)), and it was classified in Category 2 also in this classification.
7 Reproductive toxicity Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
9 Specific target organ toxicity - Repeated exposure Category 2 (thyroid, liver, kidney)


Warning
H373 P260
P314
P501
There is no human information.
As for experimental animals, in a 14-week dermal administration toxicity test using rats, at 100 mg/kg/day (converted to a 90-day equivalent: 78 mg/kg/day) within a range of Category 2 or higher, renal tubule regeneration in females were observed except for skin lesions at application sites (epidermal hypertrophy, sebaceous gland hyperplasia, chronic active inflammation, parakeratosis, and ulcer) (NTP TR 479 (2001)). In a 2-year dermal administration toxicity/carcinogenicity test using rats, at 50 mg/kg/day within a range of Category 2 or higher, increased incidences of chronic active inflammation, epithelial hyperplasia, ulcer of forestomach, and nephropathy were observed except for skin lesions at application sites (epidermal hypertrophy, sebaceous gland hyperplasia, parakeratosis, hyperkeratosis) (NTP TR 479 (2001)). In a 2-year dermal administration toxicity/carcinogenicity test using mice, at 100 mg/kg/day within a range of Category 2 or higher, foci with eosinophilic variation in hepatocytes in the liver, thyroid follicular cell hyperplasia were found except for skin lesions at application sites (epidermal hypertrophy, sebaceous gland hyperplasia, hyperkeratosis) (NTP TR 479 (2001)).
As above, except for skin lesions at application sites, nephropathy, chronic active inflammation of forestomach, eosinophilic foci in the liver, and thyroid follicular cell hyperplasia were observed in a range of Category 2. Besides, forestomach was excluded from target organs because human does not have one.
Therefore, the substance was classified in Category 2 (thyroid, liver, kidney).
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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) Classification not possible
-
-
- - The classification is not possible because appropriate data are not obtained.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - The classification is not possible because appropriate data are not obtained.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data.


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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