NITE - Chemical Management Field

GHS Classification Result

Chemical Name：1,3,3-Trimethyl-2-oxabicyclo[2.2.2]octane; 1,8-Epoxy-p-menthane
CAS：470-82-6

Result：


ID:	22A4110
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	Category 3		Warning	H226: Flammable liquid and vapour	P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. P370+P378: In case of fire: Use ... for extinction. P403+P235: Store in a well-ventilated place. Keep cool. P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking. P233: Keep container tightly closed. P240: Ground/bond container and receiving equipment. P241: Use explosion-proof electrical/ventilating/lighting/.../equipment. P242: Use only non-sparking tools. P243: Take precautionary measures against static discharge. P280: Wear protective gloves/protective clothing/eye protection/face protection. P501: Dispose of contents/container to ...	Since its flash point reported 48 degC (closed-cup) (Merck (14th, 2006)) is >= 23 degC and <= 60 degC, the substance is classified into Category 3.
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 or hydrogen.
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）	Not classified	-	-	-	-	Three LD50 values for rats of 1680 mg/kg bw (Reference: Brownlee (1940)), 2480 mg/kg bw (Reference: Bar & Greipentrog (1967)) and 2480 mg/kg bw (Reference: Jenner et al. (1964)) (all of the above: JECFA FAS 52 (2004)) were reported. One is equivalent to Category 4, and the other two are equivalent to "Not classified" of JIS classification criteria. Since the number of data equivalent to "Not classified" category was more numerous than that equivalent to Category 4, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification).
1	Acute toxicity （Dermal）	Classification not possible	-	-	-	-	No data available.
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	-	-	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	-	-	-	-	No data were available. As relevant notes, in the skin irritation tests using rabbit (OECD TG 404), the primary skin irritation index value (PII) of 1,4-Epoxy-p-menthane, isomer of the substance, was 2.25 (ECETOC TR66 (1995)).
3	Serious eye damage/eye irritation	Classification not possible	-	-	-	-	No data were available. As relevant notes, contact of the liquid with human eyes causes severe pain and blepharospasm (HSDB (2002)).
4	Respiratory sensitization	Classification not possible	-	-	-	-	No data available.
4	Skin sensitization	Classification not possible	-	-	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	-	-	-	-	The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro studies, negative results in the Ames test and in the chromosome aberration test using Chinese hamster ovary cells were reported (NTP DB (Access on Oct. 2010)).
6	Carcinogenicity	Classification not possible	-	-	-	-	Insufficient data were available. As relevant information, in the 80-week oral study in male mice at the dose levels of 8 or 32 mg/kg/day, the incidences and severities in tumors of liver, lung and kidney, or malignant lymphoma in the dose groups of this substance were not significantly different from those in the control groups (JECFA FAS 52 (2004)).
7	Reproductive toxicity	Classification not possible	-	-	-	-	In the developmental toxicity study in which rats were orally administered with the mixture containing this substance on the days 9 - 14 of gestation, at the highest dose, there were significant reductions in maternal body weight, placental weight, fetal and newborn body weight compared with controls. However, there were no external, visceral or skeletal anomalies, and there was no significant difference in the incidence of fetal malformations in the treated group by comparison with that in controls. Thus, no teratogenic effect was observed (JECFA FAS 52 (2004)). However, since sexual functions and fertility of parental animals were unknown due to no data, the substance was classified as "Classification not possible".
8	Specific target organ toxicity - Single exposure	Classification not possible	-	-	-	-	No data available.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	-	-	-	-	In the 28-day gavage or feeding studies in rats and mice, centrilobular vacuolation and fatty changes of hepatocytes were found in male rats at all dose levels (converted dose level as that of 90-day study: 58.3 - 467 mg/kg/day) in the feeding study and at 600 mg/kg/day (converted dose level as that of 90-day study: 187 mg/kg/day) or more in the gavage study. In addition, cytoplasmic alterations of the renal tubular epithelium and parotid salivary gland were observed in male rats at the dose levels of 750 mg/kg/day (converted dose level as that of 90-day study: 233 mg/kg/day) or more in the feeding study (JECFA FAS 52 (2004)). Moreover, it was also reported in the feeding study in mice that increased relative liver weight was observed accompanied by centrilobular hypertrophy of hepatocytes at the dose levels of more than 1125 mg/kg/day (JECFA FAS 52 (2004)). It was described that the liver changes in rats were not dose-related, and that these were typical of adaptive metabolic changes in the liver resulted from continuous exposure to high doses of test substance (JECFA FAS 52 (2004)). As mentioned above, because no adverse effects were seen not only within but over the guidance values in the 28-day repeated oral dose toxicity studies in rats and mice, the classification was equivalent to "Not classified" category for oral route. However, due to no available data for the other routes, the classification for specific target organ toxicity (repeated exposure) was determined as "Classification not possible".
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 = 102 mg/L for fish (Pimephales promelas) (AQUIRE, 2011).
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: 3500 mg/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）