GHS Classification Result

Chemical Name:bronopol (INN); 2-bromo-2-nitropropane-1,3-diol
CAS:52-51-7

Result:
ID: 20A2139
Classifier: Ministry of Health, Labour and Welfare (MHLW), 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 Not classified - - - - Since the substance is rated UNRTDG 4.1 III, it is not classified into Explosives.
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 solid Category 2 Warning H228: Flammable solid P370+P378: In case of fire: Use ... for extinction.
P210: Keep away from heat/sparks/open flames/hot surfaces. ? No smoking.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
The substance rated UNRTDG 4.1 III, ERG 133 is classified into Category 2.
8 Self-reactive substances and mixtures Type G - - - - Since the substance is rated UNRTDG 4.1 III, it is not classified into Self-reactive substances and mixtures.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Since the substance is rated UNRTDG 4.1 III, it is not classified into Pyrophoric solids.
11 Self-heating substances and mixtures Classification not possible - - - - Its melting point is 130 - 133degC (Chapman Ver. 16: 2 (2008)). Test methods applicable to solid (melting point <= 140degC) 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 Classification not possible - - - - No data available.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
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 ...
Since three among four of its rat LD50 values (180 mg/kg, 307 mg/kg (male), 342 mg/kg (female), and 400 mg/kg (the above, DFGOT vol. 2 (1991)) were equivalent to the guidance value of Category 4, the substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - Based on its rat LD50 = 3500 mg/kg (DFGOT vol. 2 (1991)), the substance was classified into "Not classified" in JIS classification (Category 5 in UN classification).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Category 2 Danger H330: Fatal if inhaled 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.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on its rat LC50 = 180 mg/m3/4h (= 0.18 mg/L/4h) (DFGOT vol. 2 (1991)), the substance was classified into Category 2.
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 a skin irritation test (application for 24 hours) with a 20% aqueous solution using rabbits, moderate to severe irritation was noted (DFGOT vol. 2 (1991)), but with 1% in acetone and 5% in polyethylene glycol for six hours, no irritation was found (DFGOT vol. 2 (1991)), and no irritation was observed after application of 0.5 g of the powder for 24 hours (DFGOT vol. 2 (1991)). On the other hand, in human patch tests, 0.25% and 1% in Vaseline, or a 0.25% aqueous solution, showed mild irritation (DFGOT vol. 2 (1991)). The substance is rated Xi; R37/38 in the EU classification. Therefore, the substance was classified into Category 2.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
It is documented that in a test using rabbits, application of 5% in polyethylene glycol caused reversible severe damage (DFGOT vol. 2 (1991)), in cases of application of 10, 20% aqueous solution, caused severe damage, reversible after 35 days (DFGOT vol. 2 (1991)), and it was considered that in cases of high concentration solutions, damage is not fully reversible within 21 days, and the substance was classified into Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In a maximization test using guinea pigs, weak sensitization (2/10) was reported. However, in another test using guinea pigs, no sensitization was indicated, and in human patch tests, no sensitization or false-positive results were reported. Therefore, the substance was classified into "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - Since the substance was negative in a mouse in vivo dominant lethal test (DFGOT vol. 2 (1991)), and also showed negative results in a micronucleus test using mouse bone marrow cells (HSDB (2004)), the substance was classified into "Not classified".
6 Carcinogenicity Classification not possible - - - - In both an oral administration test for two years using rats and a percutaneous administration test for 80 weeks using mice, no carcinogenicity was observed (DFGOT vol. 2 (1991)). However, since each test provided data of only one animal, due to the lack of data, the substance was classified into "Classification not possible".
7 Reproductive toxicity Classification not possible - - - - No effects on fetal development were detected in rats that received oral or percutaneous exposure during the organogenetic period or rabbits that received oral exposure during the organogenetic period (DFGOT vol. 2 (1991)). However, since these tests do not provide sufficient data on effects on parental sexual functions or fertility, classification is not possible.
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation) Warning H335: May cause respiratory irritation (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 ...
It is documented that in rats, after exposure by the dermal route, labored breathing and lung congestion were noted, and after inhalation exposure (mist), respiratory organ signs were noted, such as dyspnea and pneumonitis (HSDB (2004)). However, since the test does not provide the onset dose or exposure duration, it is not possible to classify the substance into Category 1 or 2. But, based on the description that inhalation (mist) caused dyspnea (HSDB), the substance was classified into Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 2 (respiratory system) Warning H373: May cause damage to organs through prolonged or repeated exposure (respiratory 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 a 13-week oral administration test using rats, at doses of 80 mg/kg/day or more, high mortality was noted, and most animals showed respiratory distress (gasping, wheezing), and gaseous and fluid distention of the gastrointestinal tract was seen at autopsy. At the dose of 160 mg/kg/day, signs became severer, and hemorrhagic foci in and raised white areas on the mucosa of the glandular stomach occurred (HSDB (2004)). Many rats exhibited GI lesions (superficial ulceration with underlying inflammation, epithelial hyperplasia and hyperkeratosis), and mortality became higher (HSDB (2004)). In addition, in the kidneys, distended or dilated tubules with eosinophilic material were seen in males in treatment groups (HSDB (2004)). However, stomach lesions were considered to be topical effects by irritation of the substance, and changes in the kidneys might be hyaline droplet degeneration by alpha2u globulin accumulation, unique to male rats, and they were not evaluated. As for effects on the respiratory system causing respiratory distress, since it was noted at the dose of 80 mg/kg/day or more, the substance was classified into Category 2 (respiratory system). As relevant information, other tests with oral or percutaneous administration using rats and other animal species were conducted (DFGOT vol.2 (1991), HSDB (2004)). However, none of the data obtained were considered to be sufficient for classification evidence.
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 ...
Based on its 48h-EC50 = 1.6 mg/L for crustaceans (Daphinia magna) (AQUIRE, 2008), the substance was classified into Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Since its preexisting classification for acute toxicity is Category 2, and it is not rapidly biodegradable (BOD degradability, 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), the substance was classified into Category 2.


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