GHS Classification Result

Chemical Name:imazalil (ISO); 1-[2-(allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
CAS:35554-44-0

Result:
ID: 20A2273
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 applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - The substance contains functional groups associated with self-reactive properties. Classification is not possible due to lack of data.
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 <= 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 Not applicable - - - - Organic compounds containing oxygen and chlorine, which are bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - Its melting point is <= 55degC. Classification is not possible due to lack of data.

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 ...
Its rat LD50 values documented are 664 mg/kg bw (JMPR, No. 12 (2005)), 343 mg/kg (male), 227 mg/kg (female) (JMPR, No. 12 (2005)), and 376 mg/kg bw (JMPR No. 31 (1977)). Of these values, one value falls under Category 3 and three values fall under Category 4. Adopting the category under which the majority of values fall, the substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - Based on its rat LD50 values of 4800 mg/kg (JMPR No. 31 (1977)) and 4200 mg/kg (JMPR No. 31 (1977)), the substance was classified into "Not classified" using the JIS classification criteria (Category 5 in the United Nations 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 4 Warning H332: Harmful if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
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.
Based on it rat LC50 values of 2.88 mg/L (male) and 1.84 mg/L (female) (JMPR, No. 12 (2005)), the substance was classified into Category 4. Since saturated vapour concentration of this substance at 25degC is 1.9*10^-5 mg/L, we concluded that this experiment was conducted in a mist (dust) state.
2 Skin corrosion/irritation Not classified - - - - In Draize tests using rabbits, mild skin irritation was detected (JMPR No. 12, 2005). However, in different tests using rabbits (OECD TG 404), erythema or oedema was not observed, and the substance was found to not be an irritant (JMPR No. 8 (2000)). In addition, in skin irritation tests involving several volunteers, no symptoms such as burning, itching or pain were detected (JMPR No. 8 (2000)). Based on these documents, the substance was classified into "Not classified".
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.
Since the substance was found to be moderately irritating in two Draize tests using rabbits (one test (OECD 405) gave an average score of 29 (JMPR No. 8 (2000)) and the other test resulted in an average score of 33.7 (JMPR No. 12 (2005)), the substance was classified into Category 2A. The EU Risk Phrase for this substance is R41 (EU-Annex, accessed in February 2009).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In skin sensitization tests using guinea pigs (OECD 406), 5% of subjects showed positive reactions (JMPR No. 8 (2000)). In other skin sensitization tests using guinea pigs, the substance was found to be not sensitizing (0% positive rate) (JMPR No. 12 (2005)). Despite the low sensitizing rates obtained, the substance was classified into "Classification not possible" since the results cannot be clearly interpreted.
5 Germ cell mutagenicity Not classified - - - - Based on negative results obtained in the following tests, the substance was classified into the "Not classified" category: dominant lethal mutation tests using mice (in vivo heritable mutagenicity tests using germ cells) (HSDB (2006)), micronucleus tests using mouse bone marrow cells (in vivo mutagenicity tests using somatic cells) (JMPR No. 8 (2000)), and several micronucleus tests using rats or mice (in vivo mutagenicity tests using somatic cells) (HSDB (2006)). Similarly, negative results were yielded in unscheduled DNA synthesis tests using mouse hepatocytes (in vivo genotoxicity tests using somatic cells) (JMPR No. 8 (2000): (JMPR No. 31 (1977)). Negative results were also acquired in in vitro mutagenicity tests such as Ames tests, chromosomal aberration tests, and mutation tests using cultured V79 cells from Chinese hamsters (JMPR No. 8 (2000), (HSDB (2006)).
6 Carcinogenicity Not classified - - - - In 2-year oral administration tests using rats (JMPR No. 6 (2001)), hepatocellular adenoma and follicular-cell tumors of the thyroid were observed in the animal groups treated with the highest concentration tested; however, the purity of the test substance was 50%. In contrast, in other oral administration tests using rats that were conducted for 30 months (JMPR No. 8 (2000)), histopathological effects related to the administration on the liver were not observed, concluding that there is no evidence of carcinogenicity associated with this substance. Yet, in other 2-year oral administration tests using rats (JMPR No. 21 (1980)), the conclusion was drawn that this substance is not involved in tumorigenesis of the organs. Furthermore, in 23-month oral administration tests using mice (JMPR No. 8 (2000)), although increased incidences of adenoma were detected, the conclusion was drawn that there was no statistically significant trend for carcinomas. Similarly, no signs of carcinogenicity were detected in other tests including 18-month oral administration (through drinking water) tests using mice (JMPR No. 21 (1980)), and 2-year oral administration tests using mice (HSDB (2006)). Based on these results, the substance was classified into "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 several 2 or 3-generation tests using rats, no signs of teratogenicity were detected; on the other hand, decreased survival of fetuses and increased fetal death rates were identified (JMPR No. 31 (1977), IRIS (1990), JMPR No. 8 (2000)). In reproductive toxicity tests using rats that were in compliance with OECD guidelines, besides reduced body weight in maternal animals, no significant differences were noticed compared with control animals in terms of pregnancy rates, the number of corpora lutea and implantation rates. Furthermore, in above-mentioned tests, in which developmental toxicity tests were also conducted, no signs of teratogenicity were detected in fetuses, while the number of embryos and fetuses along with fetal body weight decreased (JMPR No. 12 (2005)). Overall, while no reports on general toxicity on parental animals are available, a decrease in survival rates of fetuses and increase in fetal death rates were detected; thus, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - In 4-hour inhalation exposure tests (dust) using rats (JMPR, No. 12 (2005)), no notable effects were observed at the doses of > 20.67 mg/L, which are higher than Category 2 guidance doses. Furthermore, in dermal administration tests using rats or rabbits (JMPR, No. 12 (2005)), no toxic effects were detected using doses that fall under the category guidance values. Though these results indicate that the substance is to be placed into the "Not classified" category (inhalation and dermal), in conclusion, it was classified into "Classification not possible" because information on its toxic effects via oral administration is not available.
9 Specific target organ toxicity - Repeated exposure Category 2 (liver) Warning H373: May cause damage to organs through prolonged or repeated exposure (liver) 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 3-month oral administration tests using rats, an increased frequency of hepatocytes with small vacuoles was seen at 2400 and 3200 ppm (conversion value: 180 and 250 mg/kg for male; and 240 and 330 mg/kg for female, respectively) (JMPR No. 6 (2001)). In 14-week (3-month) oral administration tests using rats, hepathocellular necrosis was documented at the concentration of 800 ppm (90-day conversion value: 40 mg/kg) (HSDB (2006)). Furthermore, in 3-month oral administration tests using mice, an increased incidence of dark livers was identified at the highest doses (male: 140 mg/kg/day, and female: 170 mg/kg) and the middle doses for males (53 mg/kg/day); histological examination showed an increase in the numbers of small and large vacuoles, especially in the periportal area in both sexes (JMPR No. 8 (2000)). In summary, in oral exposure tests using rats or mice, the effects of exposure on the liver, such as necrosis of hepatocytes, were found in the range of doses that are comparable to Category 2 guidance values. Thus, we decided to place the substance in Category 2 (liver).
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 ...
Since its 96-hour LC50 = 1.48 mg/L for fish (rainbow trout) (ECOTOX, 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 classification for acute toxicity is Category 2 and it is not rapidly degradable (SRC: BioWin V4.10), 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)


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