GHS Classification Result

Chemical Name：N-Methylolacrylamide
CAS：924-42-5

Result：
ID: 22A4077
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 - - - - There are chemical groups (unsaturated bond) present in the molecule associated with self-reactive properties. Since no test results are available, classification is not possible.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
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 (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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 rat LD50 value of 563 mg/kg bw (NTP TR 352 (1989)), the substance was classified into Category 4.
1 Acute toxicity （Dermal） Not classified - - - - Based on the rabbit LD50 value of approximately 16000 mg/kg bw (NTP TR 352 (1989)), the substance was classified as "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） Classification not possible - - - - The rat LC50 value of > 0.319 mg/L/6hrs (= 0.478 mg/L/4hrs) was reported (IUCLID (2000)). This data did not provide information to specify an appropriate category, thus, the classification was not possible. Since the test concentration (0.319 mg/L) was higher than the saturated vapor pressure concentration (0.001 mg/L), it was judged that the substance state was dust.
2 Skin corrosion/irritation Not classified - - - - In the rabbit test, the substance caused mild to marked irritation after 24-hour application of 2,000 - 16,000 mg/kg (NTP TR352 (1989)). In this study, however, the substance was used with extremely high dose and the application time is longer than four hours. Because it was suggested that milder irritation would be detected in the ordinary test method, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 3 in the UN-GHS classification).
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. 		The substance was classified as Category 2 based on the documented case of "mild to marked irritation" resulted from rabbit test (NTP TR352 (1989)). In another rabbit test, instillation of 3 mg of the test substance to conjunctival sac caused slightly irritating (IUCLID (2000)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on the negative results in the micronucleus test using bone marrow cells obtained from mice orally or intraperitoneally administered (in vivo mutagenicity test in somatic cells) (NTP DB (Access on Jul. 2010)). As relevant information, as for in vitro studies, negative results in the Ames test, and positive results in the chromosome aberration test using CHO cells were reported (NTP DB (Access on Jul. 2010)).
6 Carcinogenicity Classification not possible - - - - The classification was concluded as "Classification not possible" based on the criterion of "Group 3" by the IARC carcinogenicity assessment (IARC 60 (1994)). As relevant information, in the 103-week oral administration study in rats and mice, no evidence of carcinogenicity was found in rats. But in mice, because the incidences of neoplasms of the Harderian gland, liver, lung and ovary increased, it was concluded that there was apparent evidence of carcinogenicity (NTP TR352 (1989)). However, IARC evaluated these findings in animal experiments was definite evidence of carcinogenicity (IARC 60 (1994)).
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 ... 		In the two-generation study in mice by oral administration in accordance with the protocol of reproductive assessment by continuous breeding (RACB), no apparent systemic toxicity was seen in F0 generation. In F0 and F1 generations, the decreased pups per litter, prolongation of inter-litter interval and increased postimplantation loss were seen. It was concluded that the exposure of the test substance produced the moderate reproductive toxicity (NTP RACB 90017 abstract (1993)). Moreover, it was also presumed that since this substance has a dominant-lethal effect, all of the reproductive toxicity in F0 generation might be related to the dominant lethal effects (NTP RACB 90017 abstract (1993)). As mentioned above, because reproductive effects were noted at the doses that were not shown general toxicity in parental animals, the substance was classified as Category 1B.
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 ... 		It was reported that the substance induced peripheral neuropathy of the same type as that induced by acrylamide in both rats and mice (IARC 60 (1994)). And it was also reported that ataxia, loss of pain and righting reflexes, and mild tonic and clonic convulsions prior to death were observed at the dose levels within the range of LD50 (350 - 510 mg/kg) following oral administration to mice (IUCLID (2000)). Thus, the substance was classified as Category 2 (nervous system). In addition, no adverse effects were described at the doses within the range of the guidance values in both inhalation and dermal routes (IUCLID (2000)).
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 13-week repeated dose oral toxicity studies in rats and mice, as for rats, hind limb ataxia was observed and progressed to hind limb paralysis in 50 mg/kg/day or more. In the neurobehavioral assessments, decreased grip strength of forelimb and hind limb as well as decreased startle response was seen at the doses of 12.5 mg/kg/day or higher, and increased incidence of degeneration of axonema and myelin sheath in the brain stem, spinal cord and peripheral nerves was seen at 25 mg/kg/day and higher (NTP TR352 (1989)). In mice, decreased grip strength of forelimb was seen at the doses of 25 mg/kg/day and higher, and exaggerated startle response and reduction in muscle coordinated movements were seen at 100 mg/kg/day (NTP TR352 (1989)). Since the effects described above were observed at the doses equivalent to Category 2 of the guidance values, the substance was classified as Category 2 (nervous system). In addition, in above 13-week repeated oral dose study in rats, distension of urinary bladder, inflammation, hemorrhage and edema of mucous membrane of the urinary bladder were observed at 25 mg/kg/day or higher. However, because there was a description in the report stating that these lesions were probably a secondary effect (NTP TR 352 (1989)), the information was not adopted for the evidence of classification.
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 = 356 mg/L for fish (Oncorhynchus mykiss) (IUCLID, 2000).
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 = 653 g/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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