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: Only a summary is available but with enough details available to describe the endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Principles of method if other than guideline:
The acute dermal LD50 of the test item was tested in rabbits administered by dermal occlusive dressing (Draize method) at a single concentration of 2000 mg/kg bw.
GLP compliance:
no
Remarks:
Pre GLP
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 2205 g.
- Housing: one animal per cage.
- Food: Nafag Würfel Nr. 84.

ENVIRONMENTAL CONDITIONS
- Temperature: 23°C ± 2°C
- Humidity: 55 ± 5%
- Photoperiod: 14 hrs light/day.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: fresh suspension with gum arabic 1% / tap water
Details on dermal exposure:
APPLICATION
One application to intact skin. Occlusive dressing (Draize method) for 24 hours.

TEST SITE
- Area of exposure: dehairing of the dorsal skin by shearing.
- % coverage: SURFACE OF 200-300 cm2

REMOVAL OF TEST SUBSTANCE
- Washing: washing the application area with lukewarm water and a sponge.

TEST MATERIAL
- Concentration: 80%
Duration of exposure:
24 hours
No. of animals per sex per dose:
3 males and 3 females.
Details on study design:
- Duration of observation period following administration: 8 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No systemic symptoms were recorded.

Any other information on results incl. tables

Skin reactions recorded

Dose mg/kg Time point N. of animals with reactions Reaction
2000 24 hrs 6/6 Erythema
2 days 1/6 Erythema, oedema
3 days 1/6
1/6
Erythema
Oedema
4 days 1/6
1/6
Erythema
Scaling, oedema
5 + 6 days 1/6 Scaling, oedema
7 + 8 days 2/6
1/6
Scaling
Scaling, oedema

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information According to the CLP regulation. Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

Method

The acute dermal LD50 of the test item was tested in rabbits administered by dermal occlusive dressing (Draize method) at a single concentration of 2000 mg/kg bw.

Results

No deaths occurred.

LD50 > 2000 mg/kg bw