Registration Dossier
Registration Dossier
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EC number: 200-945-0 | CAS number: 76-22-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other: Food and Drug Administration (FDA) Good Laboratory Practice Regulations for Nonclinical Studies (GLP Guidelines)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- ethanol
- Remarks:
- Doses / Concentrations:
0 (vehicle), 16,32,64, 125 and 250 mg/kglday
Basis:
nominal per unit area - No. of animals per sex per dose:
- There were 10 rats ofeach sex in the Core Study dose groups
- Observations and examinations performed and frequency:
- Body weights and clinical observations were recorded weekly.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- kidney weight increases, lung weight decreases
- Details on results:
- Hematology parameters were not adversely affected by camphor treatment. Decreases in blood urea nitrogen and alanine aminotransferase appeared to be related to camphor treatment and were evident early (on Days 4 and 23). However, these indices were unchanged at Day 93 and, thus, were considered not to have any toxicological significance.Relative lung weights were reduced in female rats at doses of64 and 250 mg/kg and relative kidney weights were increased in males at 64 mg/kg. All other findings at necropsy were considered incidental and consistent with those frequently seen in Fischer 344 rats ofthis age.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- the result is reliable
Additional information
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
NOAEL=250 mg/kg/day, which is more strict for us to classify this test substance
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
