GHS Classification Result

Chemical Name：2-Ethyl-1-hexanol
CAS：104-76-7

Result：
ID: 22A4068
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 Category 4 - Warning H227: Combustible liquid P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ... 		Since its flash point reported 75 degC (closed-cup) (Hommel (1996)) is > 60 degC and <= 93 degC, the substance corresponds to Category 4.
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 231 degC (HSDB (2003)), 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 halogen) 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 - - - - The eight LD50 values for rats of 2053, 3200, 3250, 3730, 3200 - 6400, 3290, 5000 and 7000 mg/kg were reported (JECFA 786 (1993), DFG MAK-Doc 20 (2003)). Seven data of them correspond to "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification).
1 Acute toxicity （Dermal） Category 4 Warning H312: Harmful in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		The rat LD50 value of > 3000 mg/kg (SIDS (J) (Access on Aug. 2010)), and the rabbit LD50 values of 1986 mg/kg (2.38 mL/kg) and > 2600 mg/kg (DFG MAK-Doc 20 (2003)) were reported. Based on the rabbit data (1986 mg/kg) as greater hazard, the substance was classified as Category 4.
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） Classification not possible - - - - Insufficient data were available. Rat LC50 values of > 0.89 and < 5.3 mg/L/4hrs were reported (DFGMAK-Doc.20 (2003)), and these data did not provide information to specify an appropriate category, thus, the classification was not possible. According to the information from the same test, 0.89 mg/L exposure was under the vapor condition, and 5.3 mg/L exposure was under the aerosol/vapor condition (IUCLID (2000)).
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P362: Take off contaminated clothing and wash before reuse. 		In the rabbit test (OECD TG 404), exposure to undiluted substance for 4 hours resulted in severe irritation with erythema, edema and scar formation, and irritation index was 6.75/8.0 (DFGMAK-Doc 20 (2003)). In other rabbits test, single 20-hour occlusive application caused slight erythema and edema formation after 24 hours, and marked desquamation was noted after 8 days (DFGMAK-Doc 20 (2003)). As mentioned above, the substance was classified as Category 2 because the intensity of the irritation was severe, and scar and desquamation remained after 8 days.
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 (OECD TG 405), instillation of 0.1 mL of undiluted test substance caused moderate to severe irritation of the cornea, iris and conjunctiva. And irritation index was 28.59/110 (DFGMAK-Doc 20 (2003)). In other rabbit test, instillation of 0.1 mL of undiluted test substance to conjunctival sac caused corneal opacity, iritis, conjunctival redness and edema. And eye irritation index (MMAS) was 51.3/110. Symptoms were all reversible in 10 - 14 days (ECETOC TR48 (1998)). Based on these documents, the substance was classified as Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - No sensitization reaction was reported in 29 volunteers with method of Kligman (maximization methods)(DFGMAK-Doc.20 (2003)) and the substance was reported as non sensitizer in reports of occupational medicine department of manufacturing and processing company (DFGMAK-Doc.20 (2003)). Based on these 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 of the dominant lethal test by oral administration in mice (in vivo inheritable mutagenicity test in germ cells) (DFGMAK-Doc 20 (2003)), the chromosome aberration test using bone marrow of rats by oral administration and the micronucleus test using bone marrow of mice by intraperitoneal administration (DFGMAK-Doc 20 (2003)) (in vivo mutagenicity test in somatic cells). As relevant information, as for in vitro studies, negative results were reported in the Ames test (JECFA 907 (1998), NTP DB (Access on August. 2010)), the chromosome aberration test with CHO cells (ECETOC TR48 (2) (1998)), the gene mutation test using CHO cells (IUCLID (2000)) and the gene mutation test using mouse lymphoma L5178Y cells (JECFA 907 (1998)).
6 Carcinogenicity Not classified - - - - In the oral administration carcinogenicity studies in rats for 2 years and in mice for 18 months, although not only the general toxicity such as suppression of body weight gain, but the increased mortality (only males in rats) were observed in high dose group (500 mg/kg/day in rats, 750 mg/kg/day in mice) , this substance showed no evidence of carcinogenicity in both animal species (JFCA 907 (1998)). Therefore, the classification was concluded as "Not classified".
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 study in rats given by gavage on the 12th day of pregnancy, while no information on maternal toxicity was reported, an increase in the number of fetuses with malformations such as hydronephrosis, tail anomalies, malformed limbs were (DFGMAK-Doc.20 (2003)). In the oral administration study using pregnant rats during the organogenetic period, the numbers of resorption and the post-implantation losses were clearly increased, and increased incidences of fetuses with dilation of the renal pelvis and hydroureter, and other skeletal malformations were observed at the doses which death, general toxic symptoms, decreased food consumption and decreased weight gain was observed in dams. Thus, it was concluded that the substance revealed teratogenicity only at the dose levels causing occurrence of toxicity on dams and embryo/fetus (DFGMAK-Doc.20 (2003)). Therefore, the substance was classified as Category 2.
8 Specific target organ toxicity - Single exposure Category 3 （Narcotic effects, Respiratory tract irritation） Warning H335: May cause respiratory irritation (narcotic effects, respiratory tract irritation)
H336: May cause drowsiness or dizziness (narcotic effects, respiratory tract irritation) 		P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Although no serious adverse effects in humans were observed from occupational exposure, it was reported that exposures to the substance may cause headaches, dizziness, fatigue, intestinal disorders, and a slight decrease in blood pressure (PATTY, 5th (2001)). With regard to the experimental animals, in the acute inhalation studies in mice, rats and guinea pigs exposed as mists of this substance (1.8 mg/L/4hrs), no deaths occurred but all animals exhibited central nervous system depression. Mucous membranes of the eyes, nose, throat and respiratory tract were irritated, but all animals recovered within one hour after exposure was terminated (JECFA 786 (1993), DFGMAK-Doc.20 (2003)). Based on these findings, the substance was classified as Category 3 (narcotic effects, respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the 3-month repeated dose study by gavage in rats, some effects containing thickening of mucosal epithelium of the forestomach were noted in the high dose group, and the NOEL of 125 mg/kg/day was reported (DFGMAK Doc.20 (2003)). Further, it was described that the NOEL in the 90-day feeding study in rats was 2500 ppm (167 mg/kg/day) and that the NOEL in the 3-month gavage study in mice was 125 mg/kg/day (DFGMAK Doc.20 (2003)). In the oral administration studies in rats and mice for two years and 18 months, respectively, no treatment-related toxic effects were documented at the treatment doses within the range of guidance values (JECFA 907 (1998)). As stated above, all NOEL values in multiple studies exceeded the range of guidance values, and no reports showed appearances of any toxic effects at the doses within guidance values, thus the classification was equivalent to the "Not classified" category in an oral route. In contrast, in the rat 90-day inhalation study no adverse effects were seen at the highest concentration of 120 ppm as vapor (0.638 mg/L), which was within the range of guidance values (DFGMAK Doc.20 (2003)). However the effect seen at the concentrations which exceeded the guidance values was unknown. Furthermore, in the repeated dermal study in rats for 16 days, it was described that the rats treated at 1.67 g/kg/day (converted dose level as that of 90-day study: 297 mg/kg/day) exhibited significant reductions in body weight and histopathological changes in the organs such as the liver and kidneys (DFGMAK Doc.20 (2003)), but the dose level exceeded the range of the guidance values, the effects within the range were unknown. Therefore, the classification for specific target organ toxicity (repeated exposure) was concluded as "Classification not possible".
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） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 96h-LC50 = 10 mg/L for fish (Lepomis macrochirus) (AQUIRE, 2011).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified as "Not classified" since it is rapidly degradable (28d-BOD degradation rate: 79 - 99.9% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1977)) and its bioaccumulation potential is estimated to be low (LogPow = 2.73 (PHYSPROP Database, 2011)) though its acute toxicity is Category 2.
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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