Registration Dossier
Registration Dossier
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EC number: 262-075-8 | CAS number: 60142-95-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-(aminomethyl)cyclohexaneacetic acid hydrochloride
- EC Number:
- 262-075-8
- EC Name:
- 1-(aminomethyl)cyclohexaneacetic acid hydrochloride
- Cas Number:
- 60142-95-2
- Molecular formula:
- C9H17NO2.ClH
- IUPAC Name:
- 2-[1-(aminomethyl)cyclohexyl]acetic acid hydrochloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- steril
- Doses:
- Dose volume of 10 ml/kg of body weight for each animal.
- No. of animals per sex per dose:
- 3 female animals was dosed at a level of 2000 mg/kg
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred in any animal dosed at 2000 mg/kg body weight. The first three animals dosed (step 1) showed piloerection starting from 30 minutes after dosing to Day 2. A single animal additionally showed reduced activity and brown staining on the muzzle from 30 minutes to 4 hours after dosing. Recovery was completed by Day 3.
The 3 animals of the second sub-group treated at the same dose level (step 2) showed piloerection starting from 30 minutes after dosing up to 4 hours after dosing. Recovery was completed by Day 2.
A single animal showed hairloss of the sacral region from Day 9 to Day 14, recovery occurring by Day 15. This clinical sign has no toxicological significance. - Body weight:
- No relevant body weight change was recorded after treatment in animals dosed at 2000 mg/kg body weight (steps 1 and 2).
A single female belonging to the first subgroup (step 1) showed a very slight body weight loss (approximately 1-2% of the body weight) from Day 2 to Day 8, recovery occurring by Day 15. This loss has no toxicological significance.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 to be greater than 2000 mg/kg body weight.
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