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Toxicological information

Acute Toxicity: dermal

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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:
guideline study with acceptable restrictions
Remarks:
Species: Rat.

Data source

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

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: A test group consisting of 3 Sprague-Dawley rats /sex was treated with single dermal applications with unchanged test substance (1000 and 2000 mg/kg bw) or a 50% test substance solution in olive oil (400 mg/kg bw). Exposure took place on 50 cm2 of clipped skin for 24 hours under occlusive conditions. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Methylimidazol in Schuppen
- Substance number: 77/697

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF-Zucht, Firma Hagemann, Extertal
- Weight at study initiation: 195 g (males) and 172 g (females)
- Diet: Herilan MRH-Kraftfutter (Firma H. Eggersrnann, Rinteln/Weser), ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 49 cm2
- Type of wrap if used: inert foil, fixed with adhesive tape

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

TEST MATERIAL
- Concentration: 50% solution
Duration of exposure:
24 hours
Doses:
1000 and 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 2, 5, 7, 9, 12 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
1000 mg/kg: none of the animals died during the 14 day observation period;
2000 mg/kg: 1/3 males and 1/3 females died during the 14 day observation period.
Clinical signs:
Beginning of irregular breathing.
Body weight:
A normal body weight gain was observed.
Gross pathology:
Diseased animals: heart: acute dilatation of the frontal prechamber, acute congestion / hyperemia; liver: slight brightening of the liver.
Euthanised animals: no abnormal observation.
Other findings:
Skin effects: 24 hours after the application a weak development of necrosis was observed, which developed to a leathery necrosis within 14 days.

Applicant's summary and conclusion