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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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

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 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test: Animals were treated for 4 hour using occlusive conditions. An application site of 2x2 cm was covered with the liquid test substance. After the application time (4 h) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 and 48 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
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 no.: 77/697

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER (6050 Offenbach)
- Weight at study initiation: ca. 2.77 kg
- Diet: Sniff K, standard diet for rabbits and guinea pigs (Firma INTERMAST GMBH, Soest), ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 80% aqueous preparation
Duration of treatment / exposure:
4 h
Observation period:
8 d
Number of animals:
6 (1 male, 5 females)
Details on study design:
TEST SITE
- Area of exposure: 2 x 2 cm
- Type of wrap:: rubberised linnencloth, fixed with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (50% or 100%) and dried with cellulose
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
2.2
Max. score:
4
Reversibility:
other: not reversible in three animals after 8 days; in two of these animals necrosis was observed (and an erythema score of 4), in the other animal desquamation, spotted necrotic tissue and an erythema score of 2 was observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h - 48 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Necrosis was observed in 3 out of 6 animals after 8 days, in the remaining animals the conditions were fully reversible within 8 days

Applicant's summary and conclusion