GHS Classification Result (Revision of the past classification result)

Chemical Name:2-Ethylhexanoic acid
CAS:149-57-5

Result:
ID: 1-051
Classifier: Ministry of Economy, Trade and Industry (METI), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives - - - - - -
2 Flammable gases (including chemically unstable gases) - - - - - -
3 Aerosols - - - - - -
4 Oxidizing gases - - - - - -
5 Gases under pressure - - - - - -
6 Flammable liquids - - - - - -
7 Flammable solids - - - - - -
8 Self-reactive substances and mixtures - - - - - -
9 Pyrophoric liquids - - - - - -
10 Pyrophoric solids - - - - - -
11 Self-heating substances and mixtures - - - - - -
12 Substances and mixtures which, in contact with water, emit flammable gases - - - - - -
13 Oxidizing liquids - - - - - -
14 Oxidizing solids - - - - - -
15 Organic peroxides - - - - - -
16 Corrosive to metals - - - - - -

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - LD50 value of the oral administration test employing a rat 1,600-3,200 mg/kg (ACGIH (7th, 2001)), There is description with 1,600 mg/kg (Patty (5th, 2001)), 3,640 mg/kg, 3,270 mg/kg, and 2,043 mg/kg (IUCLID (2000)). There are much data in which LD50 value 2,043 mg/kg of GLP based test falls within the range of "Not classified" and exists "Not classified". Although LD50 value 2,043 mg/kg corresponded to the U.N. GHS acute toxicity Category 5, it fell under unadopted category in Japan and was classified into "Not classified".
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 ...
It describes LD50 value 1,140 mg/kg (ACGIH (7th, 2001)) and 1,260 mg/kg (Patty (5th, 2001)) of the dermal administration test employing a rabbit, and describes LD50 value >2,000 mg/kg (IUCLID (2000)) of the dermal administration test employing a rabbit (OECD TG 402, GLP). Although there was a result pursuant to OECD TG and corresponding to "Not classified", since there were two or more data equivalent to Category 4 in the information source of List1, it was classified into Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - It is a liquid whose saturated vapor pressure level at 20degC is 0.23 mg/L.. Since it is written that there was no mortality even if rats were exposed to saturated steam for 8 hours in the 8-hour inhalation exposure test employing rats (ACGIH (7th, 2001)), 4-hour equivalent LC50 value is >0.46 mg/L when applying the vapor standard, and classification cannot be specified, and classification is not possible.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - It is a liquid whose saturated vapor pressure level at 20degC is 0.23 mg/L.. Since it is written that there was no mortality even if rats were exposed to 2.36 mg/L for 6 hours in the 6-hour inhalation exposure test employing rats (Patty (5th, 2001)), 4-hour equivalent LC50 value is >3.54 mg/L. when applying the mist standard. Since classification cannot be specified, classification is not possible.
2 Skin corrosion/irritation Category 1 Danger H314: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
There are descriptions, "Although undeluted liquid caused slight edema, erythema and necrosis, deluted liquid by 20% caused no or very slight edema and slight to moderate reddening" (Patty (5th, 2001)) in the study of 24 hour dermal administration to guinea pig and "slight necrosis in 5 animals and subsequent formation of slight to moderate crusts ," also in the 4 hour administration of undeluted liquid to 6 rabbits. Furthermore, there are descriptions "corrosive" in 3 cases of the 24 hour dermal stimulation study of rabbits, one of which is the result of the rabbits study in 1986 mentioned above. Although there is a description, on the other hand, "not irritating" in the dermal stimulation study (OECD TG 404, GLP) using rabbits in IUCLID (2000), delution conditions are unknown, because the primary document is a company report. Since there was a dose-dependent datum on guinea pig in the year 1955 and the existence of 3 cases in IUCLID (2000) where data were evaluated as "corrosive" without any description about recoverability could not be neglected, it was classified in Category 1.
3 Serious eye damage/eye irritation Category 2 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 ACGIH (7th, 2001), there is a description of "This substance was evaluated to Level 5 at ten steps of classifications from the research results of two cases on the eye damage on a rabbit." In IUCLID (2000), there are descriptions of "irritating at 5% and only trace injury at 1%" in the eyes irritation test where the diluent was trickled into the eye of a rabbit and of "not irritating " in the irritation to eyes of a rabbit /corrosion test (OECD TG 405, GLP). On the other hand, as a human case, there is also a description of "Although there was one case of conjunctival injury, it recovered quickly. " (Patty (5th, 2001)). Since the examination in conformity to OECD TG was a corporate data and the dilution ratio was unknown, it was not classified finely and was classified into "Category 2". In addition, as for the eye irritation test employing another rabbit, although there is a description of "severe corneal necrosis" in ACGIH (7th, 2001), there are descriptions of "irritating" in IUCLID (2000) and of "severe corneal irritation" Patty (5th, 2001), and the evaluations are divided. As for this data, the evaluations are divided depending on the information source and primary literature J.Ind.Hyg.Toxicol.26 (1944) also has described as "Accuracy is not sufficient since it is a Range Finding Test", it is not adopted.
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Classification not possible - - - - Classification is not possible since there is no data.
5 Germ cell mutagenicity Classification not possible - - - - Classification is not possible because there is no data of in vivo examination. In addition, in an in vitro mutagenicity test, there are descriptions of "positive", in chromosome aberration test and SCE test employing the CHO culture cells (NTP DB (Access on January 2009)) and "negative" (Patty (5th, 2001)) in the Ames test employing Salmonella typhimurium.
6 Carcinogenicity Classification not possible - - - - Since no evaluation by major international evaluation agencies is made and there is no data, classification is not possible.
7 Reproductive toxicity Category 1B Danger H360: May damage 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 ...
There was a description as follows in the study where it was orally administered in the form of drinking water as sodium salt in 100-600mg/kg to rats of 6-19 day pregnancy, " Although decrease in mother animals' body weight was observed at a high dose level, there was no effect below that level, and abnormalities in the bone structure such as club fold, hyperdactylia and fibular deficiency were dose dependently observed among fetuses" (Patty (5th, 2001)). When the primary literature of this study (Fundam. Appl. Toxicol. 19 (1992)) was thoroughly reviewed, there was a description as follows, "Although the number of fetuses per litter whose bone structure deformation was observed dose dependently increased compared with the control group, clubbed feet are the most serious bone structure deformation, "and NTP-CERHR (2000) describes as follows regarding this study, "There was no deformation other than clubbed feet thet showed statistically significant increase. Wavy ribs as skeletal variants increased in all administered groups." Furthermore, there is a description as follows in the study where it was administered in the form of drinking water as sodium salt in 100-600mg/kg to female rats from 2weeks before mating and during the periods of pregnancy and nursing and for 10 weeks to male rats before mating, "Among females in the highest dose group effects were hardly observed other than decrease in food consumptions and body weight and no histopathological change was observed in males' epididymis, testis, prostate and seminal capsule and non-pregnant females' ovaria, uterus and vagina. When mating with males of the highest dose group, however, conception was delayed and the number of fetuses per litter decreased" (Patty (5th, 2001)). For the reasons stated above, we classified it as Category 1B. Incidentally, there is a description as follows in Patty (5th, 2001) and ACGIH (7th, 2001), "Although neither teratogenicity nor fetal toxicity was observed in (S) body, (R) body showed high rate of exencephalia expression and the racemic body showed effects of an intermediatary degree between the two"in the study that administered to mice respective sodium salt of (R) body, (S) body and the racemic body into the ventral cavity once in the daytime and once at night on the 7th and 8th days of pregnancy, which relates the difference of fetal toxicity levels with the fact that this substance is the racemic body.. EU Classification is Repr.Cat.3; R63 (EU-Annex I).
8 Specific target organ toxicity - Single exposure Category 2 (respiratory system) Warning H371: May cause damage to organs (respiratory system) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ...
ACGIH (7th, 2001) has descriptions that "transient weakness was foreseen" in the trial which asks for oral lethal dose of rats, and that "clinical signs were not seen" within the limits of guidance value of Category 2 in the trial which carried out inhalation exposure by the saturation vapor pressure pressures higher concentrations in rats. On the other hand, the paragraph of the human impacts of HSDB (2008) which is the information source of List 2 has a description that "possibility that the dropsy of the larynx by inhalation and a bronchus, a spasm and chemical pneumonia, and a lung blister are fatal", therefore, it classified into Category 2 (respiratory systems).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 13 weeks mixed feed administration test employing rats and mice, the weight, weight gain, and intakes declined slightly" in both of rat and the mouse out of the range of the guidance value of Category 2, and the hepatocellular hypertrophy and eosinophilia of liver were seen. There is a description that the basophilic leukocytosis in the cytoplasm of a proximal convoluted tubule in mice and the acanthosis and hyperkeratosis of proventriculus in male mice have been seen."(Patty (5th, 2001)). Although material impacts are not seen in the oral route, since the influence on the inhalation route and dermal route are unknown, classification is not possible.
10 Aspiration hazard Classification not possible - - - - Classification not possible due to lack of data

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) - - - - - -
11 Hazardous to the aquatic environment (Long-term) - - - - - -


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

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Model SDS by MHLW

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