Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report, but no mortalities occured at the only concentration tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
8 days observation period
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER, Offenbach, Germany
- Weight at study initiation: male animals 2.8 kg, female animals 3.0 kg
- Diet: ad libitum Ssniff K standard diet for rabbits and guinea pigs supplied by Intermast GmbH, Soest, Germany
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks, about 50 cm2

REMOVAL OF TEST SUBSTANCE
- Washing: after removal of coverage, washing with warm water or water/Lutrol
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 200 mg/kg bw

Duration of exposure:
24 h
Doses:
200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

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: 24 hours after application parchment-like necrosis (after 8 days leather-like necrosis) and edema formation.
Gross pathology:
Nothing abnormal detected.

Applicant's summary and conclusion