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:
Meets generally accepted scientific standards, well documented and acceptable for assessment

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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Dimethylimidazol
- Substance number: 77/683

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER (6050 Offenbach, Germany)
- Weight at study initiation: 2.9 kg
- Diet: Ssniff K, standard diet for rabbits and guinea pigs (Firma INTERMAST GMBH, Soest), ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
15 to 24 hrs before treatment, dorsal and lateral parts of the body of the animals were shaved with an electric clipper exposing an area of approximatly 50 cm2

- Type of wrap if used: aluminium foil fixed with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or a water/Lutrol mixture
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration: 50 % solution
Duration of exposure:
24 hours
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
- Frequency of observations and weighing: after 1, 24 and 48 hours and on day 8
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and local skin irritaion

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the observation period.
Clinical signs:
No abnormal observations were reported.
Body weight:
Body weight was not specifically mentioned.
Gross pathology:
No abnormal observations were reported.
Other findings:
24 hours after application the animals show a mild primary skin irritation which remained consistent for almost 48 hours.

Applicant's summary and conclusion