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:
study well documented, meets generally accepted scientific principles, 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)
Principles of method if other than guideline:
BASF-Test. Rabbits were dermally exposed to a 50% aqueous solution of 2-ethyl-4-methylimidazol (400mg/kg) for 24 hour. Mortality and clinical symptoms were recorded over 8 days. Section was performed after the 8 day follow up.
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): 2-Äthyl-4(5)-methylimidazol; EMI 2,4

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: 2.77 kg (males) and 2.81kg (females)
- 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
- Dorsal and lateral sides of the animals were shaved with an electric clipper approximately 15-24 hour prior to exposure.
- Only animals with a healthy appearance and unijured skin were used for the experiments
- Coverage: approximately 180 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
- Dose: 400 mg/kg bw
Duration of exposure:
24 hour
Doses:
400 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 body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 400 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:
A normal body weight was observed.
Gross pathology:
No treatment related findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met