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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Food and Drug Administration (FDA) Good Laboratory Practice Regulations for Nonclinical Studies (GLP Guidelines)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
ethanol
Doses / concentrations
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

Examinations

Observations and examinations performed and frequency:
Body weights and clinical observations were recorded weekly.

Results and discussion

Results of examinations

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.

Effect levels

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

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion