GHS Classification Result

Chemical Name:Methacrylamide
CAS:79-39-0

Result:
ID: 22A4076
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 - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
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 solids Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - It contains chemical groups (unsaturated bond) associated with self-reactive properties in the molecule. Since no test results are available, classification is not possible.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Since it is reported that the substance is not pyrophoric [product zeigt keine selbstentzundung] (IUCLID (2000)), the substance was classified as "Not classified".
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) 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 which is chemically bonded only to carbon.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Based on the seven LD50 values for rats of 1789 mg/kg, 1774 mg/kg (the above data from "Toxicity Testing Report of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)), 459 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) Vol. 7 (2009)), 1938 mg/kg, 1653 mg/kg, 1580 - 1950 mg/kg and 1750 mg/kg (the above data from SIDS (Access on Jul. 2010)), the substance was classified as Category 4.
1 Acute toxicity (Dermal) Classification not possible - - - - Insufficient data were available. The rat LDLo value of > 1600 mg/kg was reported (SIDS (Access on Jul. 2010)). Since this value did not provide the basis for classification, the substance was classified as "Classification not possible".
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - Although it was reported that 8-hour exposure for rats at the saturated vapor pressure concentration caused no toxic effects (SIDS (Access on Jul. 2010)), the classification was not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - There were two test data in conformity with OECD TG 404 and GLP. In the first test, slight erythema in all 3 rabbits was reported after patch removal, but symptoms were reversible after 24 hours. The primary irritation index score was 0.0 and resulted as "not irritating" (SIDS (Access on Jul. 2010)). In the second study, slight to well defined erythema was noted in all 3 rabbits after patch removal, and very slight edema was noted in 1 animal. These symptoms recovered within 7 days. The primary irritation index score was 1.11 and resulted as "slightly irritating" (SIDS (Access on Jul. 2010)). Based on the information, the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes 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.
In the rabbit tests (OECD TG 405, GLP-compliant), instillation of 0.1g of test substance caused corneal opacity (Grade 1) in all 3 animals, iritis (Grade 1) in 1 animal, redness and chemosis of conjunctiva (Grade 2) in all 3 animals. Symptoms recovered in 7 days. The primary irritation index score was 3.38/13 and resulted as moderately irritating (SIDS (Access on Jul. 2010)). Based on the information, the substance was classified as Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - There were two test data of sensitization using guinea pigs. One showed slightly sensitizing, and the other revealed not sensitizing reciprocally (SIDS (Access on Jul. 2010)). In the human case, two out of the 5 patients who contacted with 1% solution showed positive reaction. However, the authors described that these reactions were not distinguished between irritative and sensitizing reaction (SIDS (Access on Jul. 2010)). The substance was classified as "Classification not possible" because sufficient data is not available on skin sensitization.
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on negative results in the dominant lethal test in mice administered via drinking water (in vivo inheritable mutagenicity test in germ cells) with no early embryonic death and post-implantation death (SIDS (Access on Jul. 2010)). As relevant information, as for in vitro studies, negative results in the Ames test (OECD TG 471, GLP-compliant) and the chromosome aberration test using CHL/IU cells (OECD TG 473, GLP-compliant) ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)) were reported.
6 Carcinogenicity Classification not possible - - - - No data available.
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 mice during the organogenetic period, increased postimplantation death was observed at doses at which decreased body weight gain was observed in maternal animals (SIDS (Access on Jul. 2010)). In the study using pregnant mice injected intraperitoneally on days 11 - 15 of gestation, increased resorption and abortions were observed at doses at which decreased body weight gain was observed in maternal animals (SIDS (Access on Jul. 2010)). Therefore, the substance was classified as Category 2. In the studies mentioned above, no treatment-related occurrence of morphological abnormalities was seen. In addition, in the one generation oral administration study of rats or two generation oral administration study of mice, no effects on sexual functions and fertility of parental animals were observed ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (Access on Jul. 2010), SIDS (Access on Jul. 2010)).
8 Specific target organ toxicity - Single exposure Category 2 (nervous system) Warning H371: May cause damage to organs (nervous 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 ...
In the single dose oral toxicity study in rats, the effects observed in dose groups at 1512 mg/kg or more included the clinical signs such as staggering gait, tremors, salivation, sitting position, and histopathological alterations in surviving animals in both sexes as follows: degeneration or necrosis of neuronal cells in central nerves as well as degeneration of peripheral nerve fibers ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)). Thus, the classification was determined as Category 2 (nervous system). In addition, it was reported that sedation and piloerection at 1000 mg/kg or higher and signs such as ataxia, prone position or somnolence at 2000 mg/kg or higher were observed in another oral study in rats (SIDS (Access on Jul. 2010)).
9 Specific target organ toxicity - Repeated exposure Category 2 (nervous system) Warning H373: May cause damage to organs through prolonged or repeated exposure (nervous system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In the 28-day repeated oral dose study in rats, the animals exhibited neural signs at 300 mg/kg/day (converted dose level as that of 90-day study: 98.3 mg/kg/day), and showed histopathological findings containing degeneration of sciatic nerve fibers and axonal swelling in cerebellar peduncle. Neurotoxic effects were not reversible after 14-day recovery period ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jul. 2010)). Moreover, in the 12-month study by drinking water in rats or mice, reduction in the rotarod performance in both species at 800 ppm (19.5 mg/kg/day) or higher, peripheral neuropathy in rats at 1200 ppm (31.6 mg/kg/day) or higher and in mice at 800 ppm (120 mg/kg/day) or higher, paralysis of hind limbs in rats at 1200 ppm (31.6 mg/kg/day) and in mice at 400 ppm (49.6 mg/kg/day) or higher were observed, respectively. Histopathological examinations revealed shrinkage and loss of myelinated fibers of the sciatic nerve at 800 ppm (19.5 - 120 mg/kg/day) or higher in both species (SIDS (Access on Jul. 2010)). As stated above, neurotoxicity was demonstrated in multiple studies at the doses equivalent to Category 2 within the range of the guidance values. Thus, the substance was classified as Category 2 (nervous system).
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 > 100 mg/L for fish (Oryzias latipes), 48h-EC50 > 1000 mg/L for crustacea (Daphnia magna) and 72h-EC50 > 1000 mg/L for algae (Selenastrum capricornutum) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1999).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" since it is not non-water soluble (water solubility = 213 g/L (PHYSPROP Database, 2011)) and its acute toxicity is "Not classified".
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)


To GHS Information