Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 January 1986 to 27 January 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: H.A.R.E. Inc Hewitt NJ, USA
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.5 to 3.5 kg
-
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 3 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard laboratory conditions
- Humidity (%): standard laboratory conditions
- Air changes (per hr): standard laboratory conditions
- Photoperiod (hrs dark / hrs light): standard laboratory conditions


IN-LIFE DATES: From: 13.01.1986 To: 27.01.1986

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
The test material was moistened with water and applied to the shaved skin. It was covered by a gauze pad, which was held in place for 24 hours with a tape. Thereafter the material was removed with tap water. Collars prevented the rabbits from ingesting the test article.
Duration of exposure:
24 hours
Doses:
2010 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
Two week observation period. Clinical signs and bodyweights recorded.
Statistics:
Not applicable.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 010 mg/kg bw
Remarks on result:
other: No notable effects on any parameters at limit dose level
Mortality:
No mortality was observed.
Clinical signs:
No signs of systemic toxicity were recorded; however, a slight erythema was noted in one male on test day two.
Body weight:
Body weight gain was normal during the observation period.
Gross pathology:
At necropsy, no remarkable findings were noted.

Any other information on results incl. tables

No notable clinical signs were observed. One male had a slight erythematous dermal response on day 2 but otherwise there were no changes indicative of derrmal irritation or systemic toxicity.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the dermal LD50 was determined to be greater than 2010 mg/kg.
Executive summary:

A single dose of 2010 mg benoxacor /kg bw was administered topically to a group of five male and five female NZW rabbits.

No notable clinical signs were observed. One male had a slight erythematous dermal response on day 2 but otherwise there were no changes indicative of dermal irritation or systemic toxicity. No mortalities occurred and the median lethal dose was found to exceed 2010 mg/kg bw. Benoxacor (CGA154281 Technical) was found to be of low toxicity when applied topically to rabbit skin on a single occasion.