Registration Dossier
Registration Dossier
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EC number: 401-310-2 | CAS number: 93912-64-2
Endpoint summary
Administrative data
Description of key information
Acute oral, rats, LD50 > 5000 mg/kg bw
Acute dermal, rats, LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago.
- Qualifier:
- according to guideline
- Guideline:
- other: Based on OECD 401 but performed to meet requirements of US and Japan
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- Male: 5000 mg/kg bw; Number of animals: 10; Number of deaths: 0
Male: 2500 mg/kg bw; Number of animals: 10; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 10; Number of deaths: 0
Male: 500 mg/kg bw; Number of animals: 10; Number of deaths: 0
Male: 250 mg/kg bw; Number of animals: 10; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 10; Number of deaths: 2
Female: 2500 mg/kg bw; Number of animals: 10; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 10; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 10; Number of deaths: 0
Female: 250 mg/kg bw; Number of animals: 10; Number of deaths: 0 - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Clinical signs:
- Signs of toxicity related to dose levels:
No clinical signs noted at 500 or 1000 mg/kg although male animals showed a decrease of spontaneous activity over 1000 mg/kg. - Gross pathology:
- Effects on organs:
No significant dose-related effects. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
sex |
dose (mg/kg) |
number of animals |
number of deaths |
M |
5000 2500 1000 500 250 |
10 10 10 10 10 |
0 0 0 0 0 |
F |
5000 2500 1000 500 250 |
10 10 10 10 10 |
2 0 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10 males
10 females - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 10; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 10; Number of deaths: 0 - Clinical signs:
- No dose related effects
- Gross pathology:
- No dose related effects
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Two in vivo studies on the substance for acute toxicity by oral and dermal route are available showing LD50 > 5000 (oral) and 2000 (dermal) mg/kg bw.
Justification for classification or non-classification
Based on the results no classification for acute toxicity is warranted under Reagulation 1272/2008
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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