Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report. Basic information is given. Only tested up to 200 mg/kg

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
according to BASF-internal standard and DOT guidelines
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals and environmental conditions:
Mean weight for male animals 2.9 kg, female animals: 2.9 kg
The animals received Ssniff K standard diet for rabbits and guinea pigs supplied by INTERMAST GMBH, Soest, FRG, and water ad libitum.
TEST ANIMALS
- Source: Breeding facility M. Gaukler, 6050 Offenbach, Germany
- Weight at study initiation: mean weight 2.9 kg for males and females
- Diet: ad libitum (Ssniff K, standard diet, INTERMAST GMBH, Soest, Germany)
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flank
- coverage: 50 cm2
- Type of wrap if used: inert foil fixed with an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water or a mixture of water and lutrol
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration: 50 % aqueous solution
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
200 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: after 1, 24, 48 h and on Day 8
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Signs of systemic toxicity: none
Signs of local irritation: initial slight reddening, reversible within 8 days
Body weight:
Not observed
Gross pathology:
No substance-related organ findings

Applicant's summary and conclusion

Conclusions:
The acute dermal toxicity of the test substance in Vienna white rabbits was determined. The product was applied as a 50% aqueous test substance preparation by single dose of 200 mg/kg for 24 hours on clipped areas (about 50 cm2) of the back and flanks. The determination of the LD50 was based on the DOT guidelines, but no exact LD50 was established.