Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report with restrictions (only one test concentration, occlusive dressing, limited data on test material, only 2 animals per dose and the skin of half of the animals was abraded, no GLP)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969
Reference Type:
other: Correspondence
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(only one test concentration, occlusive dressing, limited data on test material, only 2 animals per dose and the skin of half of the animals was abraded)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Albino Rabbits
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult albino rabbits
- Weight at study initiation: Mean bodyweight of about 3 kg
- Housing: Individual cages
- Diet: standard rabbit ration
- Water (ad libitum)
- Acclimation period: At least 7 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- 24 hours before dermal application, the backs of the rabbits were shaved free of hair with electric clippers
- One rabbit of each sex was further prepared by making epidermal abrasions every 2 or 3 cm longitudinally over the area of exposure; the abrasions were sufficiently deep to penetrate the stratum corneum, but not cause bleeding.
- Area of exposure: Back
- % coverage: 10% of total surface-area
- Type of wrap if used: Impervious plastic sheeting securely taped in place to ensure intimate contact of epidermis and test material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The animals were thoroughly cleaned. No further details.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount: 3 g of the test substance prepared as cream with polyethylene glycol
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
1100 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: No details
- Frequency of weighing: At start and end of the study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occured.
Mortality:
No mortality occured.
Clinical signs:
- Scarified animal sites: Behaviour normal, very slight erythema at 24 hours, reversible within 72 hours
- Unscarified animal sites: Behaviour normal, very slight erythema and well-defined erythema at 24 hours, reversible within 72 hours

This application produced mild local reactions in all four animals
Body weight:
No data on body weigth development.
Gross pathology:
- Scarified animals: nothing unusual at autopsy
- Unscarified animals: nothing unusual at autopsy

Applicant's summary and conclusion