Registration Dossier
Registration Dossier
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EC number: 449-430-4 | CAS number: 99189-60-3 1,1-CYCLOHEXANE DIACETIC ACID MONOAMIDE (CAM); 1,1-CYCLOHEXANEDIACETIC ACID MONOAMIDE
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,1-cyclohexanediacetic acid monoamide
- EC Number:
- 449-430-4
- EC Name:
- 1,1-cyclohexanediacetic acid monoamide
- Cas Number:
- 99189-60-3
- Molecular formula:
- C10H17NO3
- IUPAC Name:
- 2-[1-(carbamoylmethyl)cyclohexyl]acetic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- steril
- Doses:
- 2000mg/kg in a volume of 20mL/Kg as a suspension in steril water.
- No. of animals per sex per dose:
- ten animals (5 males and 5 females)
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: no clinical signs were observed
- Gross pathology:
- red spots were reported on the lungs of one female (1/5). this finding was frequently reported in laboratory rats, relation to the treatment was unlikely.
No organ or tissue gross findings were seen at necropsy of other animals.
Any other information on results incl. tables
A dose of 2000mg/kg caused no mortality and did not require euthanasia during a 14 -day period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oral administration of the test substance at dose of 2000 mg/Kg caused no mortality and did not require euthanasia during a 14-day period, in the male or female Sprague-Dawley Rat.
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