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Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-06-15 to 1992-03-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and a well-documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Naval Distillate (CAS# 68334-30-5)
IUPAC Name:
Naval Distillate (CAS# 68334-30-5)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

open allclose all
Dose descriptor:
NOEL
Remarks:
systemic
Effect level:
0.5 other: ml/kg
Sex:
male/female
Dose descriptor:
NOEL
Effect level:
0 other: ml/kg
Sex:
male/female
Basis for effect level:
other: based on dermal irritation

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOEL level based on dermal irritation was 0.0001 ml/kg and a NOEL of 0.5 ml/kg was calculated for systemic toxicity.
Executive summary:

In a repeated dose oral toxicity study Naval distillate was administered to male and female Sprague Dawley rats at dose levels of 0.0001, 0.005, and 0.5 mL/kg were administered 5 days/week over a 4 week period.

The test material produced slight dermal irritation at a dose of 0.005 mL/kg and severe irritation at a dose of 0.50 mL/kg as evidenced by grossly visible dermal irritation and microscopic changes in the skin. A dose-dependent decrease in mean trglyceride was noted in males at a dose of 0.50 mL/kg. No other treatment related effects were observed in any of the parameters evaluated. No treatment-related effects were noted in examination of the weight and histopathology of testes and ovaries.

The NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity.

This study received a Klimisch score of two and is classified as reliable with restriction because it is an acceptable and a well-documented study report.

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