GHS Classification Result

Chemical Name:2-Ethylhexane-1,3-diol; Octanediol
CAS:94-96-2

Result:
ID: 22A4144
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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 - - - - 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 Not classified - - - - Although measurement method of the flash point 127 degC is unknown (HSDB (2003)), it is estimated that the flash point measured by the closed-cup method is >= 93 degC. Therefore, the substance is classified as "Not classified".
7 Flammable solids Not applicable - - - - Liquid (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 Not classified - - - - Since its autoignition temperature is 340 degC (Hommel (1996)), it is considered that the substance does not ignite at room temperature.
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 Not applicable - - - - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Six LD50 values for rats of 2350, 2710, 9259, 4625, 5170 and > 5000 mg/kg bw were reported (all from DFGMAK-Doc. 5 (1993)), they are all equivalent to "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).
1 Acute toxicity (Dermal) Not classified - - - - Three LD50 values for rats of 18800, 10227 and 8939 mg/kg were reported (DFGMAK-Doc. Vol.5 (1993)), and they are all equivalent to "Not classified".
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified - - - - Based on the data that exposure of 4800 ppm/8hrs (28.7 mg/L) (converted value as that of 4-hour exposure: 57.4 mg/L) to rats caused no mortality (PATTY, 5th (2001)), the substance was classified as "Not classified". The test concentration (4800 ppm) was higher than the saturated vapor pressure concentration (3.9 ppm), the criterion values for mist were adopted.
2 Skin corrosion/irritation Not classified - - - - The substance was classified as "Not classified" based on the report that 4-hour occlusive application of undiluted substance caused only slight erythema (irritation score: 0.5/8) in the rabbit test (OECD guideline) (DFGMAK-Doc.5 (1993)).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
In the rabbit test, severe irritation was noted. In another rabbit test, corneal opacity, irritation of iris, and redness/edema of conjunctiva were noted (irritation score: 35/110). Symptoms of the cornea were disappeared after 10 days (DFGMAK-Doc. 5 (1993)). Based on the information, the substance was classified as Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - In the maximization test using 20 guinea pigs, no positive reaction was seen after elicitation (positive rate 0%) (DFGMAK-Doc. 5 (1993)). In the patch test of 223 subjects, slight erythema was developed in 3 subjects, but there was no sign of sensitization (DFGMAK-Doc. Vol.5 (1993)). Based on the information, the substance was classified as "Not classified".
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on the negative results in the chromosome aberration test using bone marrow cells of rats intraperitoneally administered and micronucleus test using bone marrow cells of mice intraperitoneally administered (in vivo mutagenicity test in somatic cells) (DFGMAK-Doc. Vol.5 (1993)). As relevant information, as for in vitro studies, negative results in the Ames test and in the chromosome aberration test using CHO cells were reported (DFGMAK-Doc. Vol.5 (1993)).
6 Carcinogenicity Classification not possible - - - - The classification was not possible due to lack of data. As relevant information, in the 110-week dermal administration using mice, dose-dependent increasing tendency in the incidence of tumors was noted, and lymphomas, hemangiosarcomas of liver and lung adenomas were observed in both of the dose groups and control group. However, these findings were not statistically significant, and slight occurrence of skin tumors was also observed (DFGMAK-Doc Vol.5 (1993)).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
In the oral administration study using pregnant rats during the organogenetic period, the postimplantation losses and the incidence of malformations (rudimentary or filamentous tails, malformation of hindlimbs and joints, shortened trunk and umbilical hernia) were significantly increased at the dose causing maternal toxicity. Moreover, malformations were observed even at the low dose group (DFGMAK-Doc. 5 (1993)). Therefore, it was classified as Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - The classification was not possible due to lack of sufficient data. It was reported, in the acute oral toxicity study in rats, that the substance caused deep depression of central nervous system at the doses over the range of Category 2 of the guidance values, and that this was concluded to be a cause of death (PATTY, 5th (2001)).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - The classification was not possible due to lack of sufficient data. As relevant information, in the 30-day feeding study in rats, the only finding at the highest dose (700 mg/kg/day) was the suppression of body weight gain, while histopathological examination was not carried out. In the 2-year feeding study in rats, it was reported that no substance-related organ damage was revealed up to 4% (2000 mg/kg/day) (DFGMAK-Doc. 5 (1993)). Additionally, in the 90-day dermal toxicity study in rabbits treated at 1880 mg/kg/day or 3760 mg/kg/day, it was reported that about half the number of the animals died and damage in the liver and kidneys was seen. However, no further details or no histopathological findings were reported (DFGMAK-Doc.5 (1993)).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Not classified - - - - Classified as "Not classified" from its 96h-LC50 = 624 mg/L for fish (Ictalurus punctatus) (AQUIRE, 2011).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" since its acute toxicity is "Not Classified" and it is not non-water soluble (water solubility = 42000 mg/L (PHYSPROP Database, 2011)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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