GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 25637-99-4 |
| Chemical Name | Hexabromocyclododecane |
| Substance ID | H28-A-013, C-052A |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
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 |
- |
- | - | 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 | Not classified |
- |
- | - | It is not combustible (ICSC(J) (2001)). |
| 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 |
- |
- | - | It is not combustible (ICSC(J) (2001)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (ICSC(J) (2001)). |
| 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 no oxygen, fluorine or chlorine. |
| 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. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on the LD50 value (equivalent to OECD TG 401) of >10,000 mg/kg for rats (EU-RAR (2008), NICNAS (2012)), the substance was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on the LD50 values (equivalent to OECD TG 402) of >8, 000 mg/kg and >20,000 mg/kg for rabbits (NICNAS (2012), EU-RAR (2008)), the substance was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | Based on the 2 reports of LC50 values of > 202 mg/L in a 4-hour inhalation exposure test using rats and > 200 mg/L (converted 4-hour equivalent value: > 50 mg/L) in a 1-hour inhalation exposure test using rats (EU-RAR (2008), NICNAS (2012) in both tests), the substance was classified as "Not classified." |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | In a skin irritation study using rabbits (OECD TG 404), very slight erythema was observed, but the irritation was concluded to be negative (EU-RAR (2008), NICNAS (2012)). Therefore, the substance was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | In eye irritation studies (OECD TG 405) using rabbits, although slight irritation was observed, it was concluded that the substance is not an eye irritant (EU-RAR (2008), NICNAS (2012)), therefore, the substance was classified as "Not classified." |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Not classified |
- |
- | - | Based on the negative results of both maximization tests using guinea pigs and LLNA (OECD TG 429, GLP-compliant) (EU-RAR (2008), NICNAS (2012)), the substance was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo data, the result of the micronucleus test using mouse bone marrow cells was negative (EU-RAR (2008), NICNAS (2012)). As for in vitro data, the results of bacterial reverse mutation tests and a mammalian cell chromosomal aberration test were negative (EU-RAR (2008), NICNAS (2012), NTP DB (Access on June 2016)). From the above, the substance was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, in an 18-month feeding study using mice, a tendency of increased frequency in liver carcinomas was suggested in females. Nevertheless the incidences of total liver tumors were within the range of background data (EU-RAR (2008), NICNAS (2012)). |
| 7 | Reproductive toxicity | Category 1B |
 Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
In a 2-generation reproductive toxicity study using rats administered by feed, a dose-dependent decrease in the fertility index in F0 parent animals from low dose (150 ppm) and a decrease in the number of primordial follicles in F1 female parent animals of the mid dose (1,500 ppm) or above were observed. In pups, increased pup mortality during lactation was observed in the F2 generation of 1,500 ppm or above (EU-RAR (2008), NICNAS (2012)). As for neurobehavioral effects during development, after a single oral administration of this substance to postnatal day 10 neonatal mice, a behavioral tests were conducted at the age of three months. As a result, a decrease in locomotion in the low-dose group (0.9 mg/kg) was observed. In the high dose group (13.5 mg/kg), spontaneous behavior was altered, manifested as initial hypoactivity followed by hyperactivity. Moreover, in water maze tests, a decrease in learning capability was observed (EU-RAR (2008), NICNAS (2012)). Therefore, the substance was classified in Category 1B based on reproductive and developmental effects in a 2-generation reproductive toxicity study using rats and neurobehavioral effects on neonatal mice. |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (Narcotic effects) |
 Warning |
H336 |
P304+P340
P403+P233 P261 P271 P312 P405 P501 |
It is reported that hypoactivity and ptosis were observed in single-dose oral studies using rats and mice (EU-RAR (2008), NICNAS (2012)), and that apathy and trembling were observed in a single-dose oral study using mice (EU-RAR (2008)). Therefore, the substance was classified in Category 3 (narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
No data available for humans. As for experimental animals, in 90-day repeated dose toxicity studies using rats administered by gavage, an increase in liver weights and minimal hepatocellular vacuolisation were observed at 100 mg/kg/day, which is within a range of Category 2. These findings were reversible (EU-RAR (2008), NICNAS (2012)). Also, it was found that the vacuoles contained lipids (EU-RAR (2008)). As described above, although liver effects were observed, they were slight changes and were reversible. Therefore, because the information was thought to be insufficient for the basis of the classification, the substance was classified as "Classification not possible." |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 1 |
 Warning |
H400 |
P273
P391 P501 |
From 72-hour ErC50 = 0.052 mg/L for algae (Skeletonema costatum) (EU-RAR, 2008), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 21-day NOEC (survival, reproduction, growth) = 0.0031 mg/L for crustacea (Daphnia magna) (EU-RAR, 2008; NICNAS, 2012). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to not being rapidly degradable (BIOWIN), and 72-hour ErC50 = 0.052 mg/L for algae (Skeletonema costatum) (EU-RAR, 2008). It was classified in Category 1 from the above results. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |