GHS Classification Result

Chemical Name:6-Ethoxy-1,2-dihydro-2,2,4-trimethylquinoline; Ethoxyquin
CAS:91-53-2

Result:
ID: 22A4102
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 - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Classification not possible - - - - No data available.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Classification not possible - - - - No data available.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid 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 - - - - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - No data 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 1700 mg/kg bw (JMPR (1998)), the substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - Based on the rat LD50 value of > 2000 mg/kg bw (JMPR (1998)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).
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 classification was not possible due to lack of sufficient data. Although the rat LC50 value of > 2.0 mg/L was reported (JMPR (1998)), exposure time was not described. The saturated vapor pressure concentration at room temperature was 0.0015 mg/L, the criterion values for mist were adopted.
2 Skin corrosion/irritation Not classified - - - - The substance was classified as "Not classified" based on the documented case that slight erythema without edema was observed and desquamation were noted at 7 days after application in the rabbit test (JMPR (1998)).
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.
The substance was classified as Category 2B based on the documented case that the transient conjunctival redness and chemosis was noted, but symptoms were all reversible within 4 days (JMPR (1998)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
The substance which was used in animal feed as an antioxidant caused contact dermatitis to feed flour milling worker, and reported as a sensitizer (Contact Dermatitis, Frosch, 4th (2006)). Based on this information, the substance was classified as Category 1. As relevant notes, a number of reports indicated that the substance has been the probable cause of severe dermatitis often seen in workers who handle animal feed containing the substance. Positive results in patch tests were recorded in workers (JMPR (1998)).
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 obtained from mice orally administered (JMPR (1998)) as well as intraperitoneally administered (NTP DB (Access on Oct. 2010)) (in vivo mutagenicity test in somatic cells). As relevant information, as for in vitro studies, negative results in the Ames test and chromosome aberration test using CHO cells (NTP DB (Access on Oct. 2010)), and positive results in the chromosome aberration test using CHO cells (JMPR (1998)) were reported.
6 Carcinogenicity Classification not possible - - - - The classification was not possible due to lack of sufficient test data. As relevant information, in the 2-year dietary administration test in rats, pathological changes were observed in the renal cortex of males 200 days after administration, and carcinogenicity was found in some organs without dose response 700 days after administration and these were observed also in the control group at that time. In addition, there were some data of 30-week or 1-year dietary administration test in rats (JMPR (1998)), however, no clear evidence for carcinogenicity was noted.
7 Reproductive toxicity Not classified - - - - In the multigeneration reproductive toxicity study in rats by feeding, no effects on reproduction, as reflected in fertility, litter size, or survival of offspring, was observed. In the two-generation reproductive toxicity study in dogs by feeding, decrease in body weight due to administration was observed, but, there were no effects on copulation performance, delivery, weaning indices, semen parameters, clinical signs, number of live pups, litter size, pup weight and growth. In addition, in the study using pregnant rats orally administered on days 6 - 19 of gestation, decrease in maternal body weight were observed, however, there were no effects on uterine weights, litter size, resorption, pre- and post-implantation losses, sex ratios, and fetal weights. The findings of malformations and anomalies were within the range of historical controls (JMPR (1998)). Thus, the substance was classified as "Not classified".
8 Specific target organ toxicity - Single exposure Category 1 (liver) Danger H370: Causes damage to organs (liver) P307+P311: IF exposed: 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.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
In the single dose oral study in dogs (dose levels: 50, 100 and 200 mg/kg), no treatment-related effects on hematology and necropsy were observed, but higher serum bilirubin concentrations, lower urea nitrogen concentrations and mild cholestasis in the microscopic examination were observed in both sexes of all treatment groups. In addition to cholestasis, deposits of hepatocellular glycogen were depleted in the dogs at 200 mg/kg/day. At the end of the observation period, minimal cholestasis was also observed in all treatment groups (JMPR (2005)). As stated above, since the effective doses were confirmed within Category 1 of the guidance value, the substance was classified as Category 1 (liver).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (liver) 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.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In the 90-day oral toxicity study in dogs, total bilirubin concentration and activity of ALP, GPT, GOT and gamma-GT was increased, and hepatic changes containing increased pigment deposition, hepatocellular necrosis, cytoplasmic vacuolation and bile-duct hyperplasia were microscopically observed at 20 mg/kg/day or more. Increase of ALP, and mild pigment deposition and hepatocellular necrosis were also observed even at 4 mg/kg/day (JMPR (1998)). In another 28-day oral toxicity study in dogs, increase of activity of the serum enzymes indicating liver damage and pigment deposition of the liver was observed at 25 mg/kg/day (converted dose level as that of 90-day study: 8.3 mg/kg/day) or more (JMPR (1998)). Further, in the 28-day oral dose study in rats, increases of total bilirubin concentration and elevation of activity of gamma-GT were also reported at 250 mg/kg/day (converted dose level as that of 90-day study: 77.7 mg/kg/day) or more (JMPR (1998)). As described above, since the lowest effective doses belonged to Category 1 in the dog studies, the substance was classified as Category 1 (liver). As relevant information, the effects on the kidneys were observed in both 28-day and 13-week studies in rats, however, both of the effective doses were over the range of the guidance values. Therefore, the information was not adopted as the basis 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) Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 1 from its 72h-ErC50 = 0.70 mg/L for algae (Pseudokirchneriella subcapitata) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 1998).
11 Hazardous to the aquatic environment (Long-term) Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (Non-biodegradable, BOD degradation rate: 3% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1982)).
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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