Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to the relevant guideline under GLP conditions, inclusive certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Clear yellowish liquid,

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Male and female rats obtained from Harlan Olac Ltd, Bicester Oxon, England.
Rats were housed individually in metal cages with wiremesh floor. Standard rodent diet and water were provided ad libitum.
Temperature was 21C, relative humidity was 50-51%, and 12:12 light:dark period.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Five males and five females were treated. The day before treatment, the hair was removed from the dorso-lumbar region, approximately 10% of bodysurface (5*5 cm). The test substance was applied, by spreading it evenly, and then covered by gauze, and kept in place with a non-irritative dressing, encircled firmly around the trunk.
Duration of exposure:
14 days
Doses:
2.9 g/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the experiment
Clinical signs:
No signs of systemic reactions to treatment
Body weight:
Slightly low bodyweight gains were recorded for one male and three females on day 8, and two males and four females at day 15
Gross pathology:
No macroscopic abnormalities onserved at day 15
Other findings:
Slight or well-defined erythema was observed at the site of application, for two male and three female rats on day 2. No other dermal changes and irritation has resolved at day 3.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance can not be considered acutely toxic via the dermal route.
Executive summary:

Rats of both sexes were given 2 g/kg as a single dermal exposure and followed 14 days after exposure.

No mortality was observed . I addition no clinical signs nor macroscopic abnormalities were observed. A slight or well defined erythema was observed at the site of application for 2 and 3 male and females rats on day 2, respectively. No other dermal changes was observed, and irritation had resolved at day 3.

The substance can not be considered acutely toxic via the dermal route.