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:
comparable to guideline study with acceptable restrictions
Remarks:
pre-GLP, pre-OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
BASF-test (application on intact skin, for 24 hours, under occlusion)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Substance name: 1-methylimidazol
Substance number: 79/527

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M .GAUKLER, 6050 Offenbach
- Weight at study initiation: males 3.1 kg, femalses 3.0 kg
- Diet: Ssniff K, standard diet for rabbits and guinea pigs (Fa. INTERMAST GMBH, Soe) and Ovator Solikanin (Fa. Muskator-Werke, Düsseldorf) ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 110 cm2 (clipped skin)
- Type of wrap if used: inert foil fixed with a adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or a water/Lutrol solution
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
250, 400 and 640 mg/kg bw
No. of animals per sex per dose:
3 (250 and 640 mg/kg bw) and 6 (400 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: 1 h and 1, 2, 7 and 15 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
400 - 640 mg/kg bw
Based on:
test mat.
Mortality:
250 mg/kg bw: no mortality occurred
400 mg/kg bw: 2/6 males and 0/6 females
640 mg/kg bw: 1/3 males and 3/3 females
Clinical signs:
Resorptive intoxications symptoms:
apathy, accelerated breathing, spasms, salivation, excess lacrimation, narrowed pupils

Local irritation symptoms:
Besides obvious redness of the skin and edema at the end of the observation period necrotic changes in the skin and persistent edema were observed.
Body weight:
No effects
Gross pathology:
Animals which died during the study: dilatation of the heart and hyperemia in the lungs. In the animals which were sacrified at the end of the study no effects were observed.
Other findings:
Skin findings: firstly, erythema and edema. During the observation period necrosis was observed.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria