Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
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:
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
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