Registration Dossier

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:
other: comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: BASF internal standard protocol
Principles of method if other than guideline:
The fur of 2 rabbits was clipped and the unchanged test substance was applicated using a soaked test patch (2.5 x 2.5 cm). The patch was applicated onto the back of the animals. After an occlusive exposure period of 1, 5 and 15 minutes as well as 20 hours the application area was washed with Lutrol/water (1:1). Furthermore the ears were wrapped for 20 hours with a patch soaked with the test substance. Skin effects were documentated 24 hours and 8 days after the removal of the test patches.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
ca. 1 g
Duration of treatment / exposure:
1 min, 5 min, 15 min, 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
The test substance was washed off with 50% Lutrol.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
back skin
Time point:
other: 1/5/15 min exposure, reading after 24 h
Score:
1
Reversibility:
not reversible
Remarks on result:
other: slight erythema 24 h after occlusive exposure for 1, 5 and 15 minutes, respectively
Irritation parameter:
other: irritation score
Basis:
mean
Remarks:
back skin
Time point:
other: 1/5/15 min exposure, reading after 8 days
Score:
1
Reversibility:
other: symptoms on the last study day
Remarks on result:
other: severe irritation 8 days after occlusive exposure for 1, 5, and 15 minutes, respectively
Irritation parameter:
other: necrosis score
Basis:
mean
Remarks:
back skin
Time point:
other: 20 h exposure, reading after 24 h
Score:
2
Reversibility:
not reversible
Remarks on result:
other: marked necrosis (full thickness) 24 h after an 20 h of occlusive exposure
Irritation parameter:
other: necrosis score
Basis:
mean
Remarks:
back skin
Time point:
other: 20 h exposure, reading after 8 days
Score:
2
Reversibility:
other: symptoms on last study day
Remarks on result:
other: marked necrosis (full thickness) 8 days after an 20 h occlusive exposure

Any other information on results incl. tables

24 h after the exposure for 1, 5, and 15 minutes, respectively, the skin on the back showed a slight erythema which emerged as severe irritation 8 days after the application. Treatment of the back skin for 20 h caused marked (full thickness) necrosis with dermatorrhagia after 24 h and 8 days. The ear showed severe irritation 24 h after the 20 h exposure and marked (full thickness) necrosis 8 days after the application.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test item caused sever irritation 8 days after an exposure of 1, 5, and 15 minutes, respectively, and skin corrosion after an exposure for 20 h.