GHS Classification Result

Chemical Name:2,4,6,8-Tetramethyl-1,3,5,7-tetraoxacyclooctane
CAS:108-62-3

Result:
ID: 21A3690
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

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 solids Category 2 Warning H228: Flammable solids 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 is classified into Division 4.1, PG III in UNRTDG (UN1332).
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 Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - The substance does not fall into upper Division 4.2 (Substances liable to spontaneous combustion) since it is classified into Division 4.1, PG III in UNRTDG (UN1332).
11 Self-heating substances and mixtures Not classified - - - - The substance is judged not fall into upper Division 4.2 since it is classified into Division 4.1 in UNRTDG (UN1332).
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 which is chemically bonded only to carbon.
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 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on a LD50 value of 283 mg/kg for rats (EPA RED (2006), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)), the substance was classified into Category 3.
1 Acute toxicity (Dermal) Not classified - - - - Based on a LD50 value of 5000 mg/kg and higher for rats (EPA RED (2006), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)), the substance was classified as "Not classified".
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) Not classified - - - - Based on a LC50 value (4h) of 314 mg/L for rats (EPA RED (2006)), the substance was classified as "Not classified". Since the saturated vapour pressure is 0.0064 mg/L at room temperature, the test was considered to be conducted for dust or mist.
2 Skin corrosion/irritation Not classified - - - - Based on a report of "not irritant" in a rabbit test (EPA RED (2006), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)).
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.
Based on a report of "mild irritant" in a rabbit test (EPA RED (2006), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on a result of not sensitizing (positive ratio: 0.8%, 1/12) in a Buehler guinea pig skin sensitization test (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)) and results of not sensitizing for 30% flowable (positive ratio: 0%, 0/25) and 10% granule (positive ratio: 0%, 0/20) in a maximization test and Buehler test, respectively, (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)), the substance was classified as "Not classified".
5 Germ cell mutagenicity Not classified - - - - Based on a negative result in an oral mouse bone marrow micronucleus test (in vivo somatic cell mutagenicity tests) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of a negative Ames test and a negative CHO cell chromosomal aberration test (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)).
6 Carcinogenicity Classification not possible - - - - Although there is a report that no tumorgenicity was observed in a mouse 78-week feeding test (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)), there is also a report that incidence of hepatocellular adenomas and incidence of combined hepatocellular adenomas and carcinomas were increased in females of the highest dose group in a rat 2-year feeding combined toxicity/carcinogenicity test (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)). Since evidence of carcinogenic activity was observed in female rats only and not in males, classification was not possible.
7 Reproductive toxicity Not classified - - - - A two generation reproduction feeding test with rats (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)) and a three generation reproduction feeding test with rats (JMPR WHO/FAO Data Sheets on Pesticides No. 93 (1996)) were conducted. In a three generation test, fertility, viability and lactation indices were reduced at high dose level (5000 ppm). However, the adverse effects are considered to be observed only at a very high dose level and the information was not used as the basis of classification since hind-limb paralysis and mortality were observed in dams at the high dose level. At lower dose levels, hind-limb paralysis and effects on body weights and liver weights were observed but no effect on reproductive parameters were observed. In developmental toxicity tests by oral administration to rats and rabbits during organogenesis period (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)), there were no significant differences in parameters of pregnancy and fetal development in comparison to the control group. No increase in incidence of malformations and variations related to treatment was noted in either species while effects on body weight, food consumption and liver weight were observed. Based on this information, the substance was classified as "Not classified" since there were no adverse effects on parental sexual function and fertility and fetal development.
8 Specific target organ toxicity - Single exposure Category 1 (nervous system) Danger H370: Causes damage to organs (nervous system) 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 ...
Convulsions (for 3 days), coma (for 7 days) and memory loss were caused in humans following accidental ingestion of metaldehyde (PIMs (1999)). Hunchback position, lethargy and piloerection were observed in rats after an oral administration at dose levels of 100 - 800 mg/kg and sporadic signs included ataxia, whole body tremor and tonic convulsion (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)). Additionally, in a mouse oral test, 9/10 and 10/10 mice exhibited tonic flexion and extension convulsion at dose levels of 30 and 100 mg/kg (both within the guidance value range for Category 1), respectively, (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)). Based on this information, the substance was classified into Category 1 (nervous system).
9 Specific target organ toxicity - Repeated exposure Category 2 (nervous system, liver, testis) Warning H373: May cause damage to organs through prolonged or repeated exposure (nervous system, liver, testis) 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 rat 107-week feeding test, hind-limb paralysis was observed at dose levels of 20 - 100 mg/kg bw/day and lesions of the spinal cord were observed in the top dose (JMPR WHO/FAO Data Sheets on Pesticides No. 93 (1996)). In a dog 52-week feeding test, symptoms such as ataxia, tremors and convulsions as well as histopathological findings such as testicular giant cells, atrophy and degeneration of the germinative epithelium and atrophy of the prostate were observed (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)). Since these findings were observed at dos levels within the guidance value range for Category 2, the substance was classified into Category 2 (nervous system, testis). In addition, in a rat 90-day feeding test, liver histopathological changes (centrilobular hepatocyte hypertrophy) were observed in both sexes at 750 and 2500 ppm (approximately 37.5 and 125 mg/kg/day). In a mouse 90-day feeding test, hepatocellular necrosis, hypertrophy, hyperplasia, inflammation, anisokaryosis and vacuolization were observed at 1000 ppm, and the same lesions in minimal degree were observed at 100 and 300 ppm (15 and 45 mg/kg/day) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2009)). Based on this information, the substance was classified into 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) Not classified - - - - Classified into Not classified from its 96h-LC50 = 149.8 mg/L for fish (Bluegill) (AQUIRE, 2010).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since its acute toxicity is Not classified and it is not non-water soluble (Water solubility: 222 mg/L (PHYAPROP Database, 2009) and is low bioconcentration potential (LogKow = 0.22 (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2004)).


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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