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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:
other: Scientifically valid study, but not according to current standards or GLP; partly limited documentation (e.g. no details about the test substance).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Principles of method if other than guideline:
Skin irritation in rabbits ( BASF-Test)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data

Test animals

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

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
pad (2.5 cm x 2.5 cm) was covered with the undiluted liquid test substance (no further data)
Duration of treatment / exposure:
1, 5, 15 minutes or 20 h
Observation period:
Scoring 24, 48, 72 h after removing the patch and at day 8.
Also immediately after removing the patch.
Number of animals:
2
Details on study design:
Vienna rabbits were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 cm x 2.5 cm was covered with the undiluted liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. The results from the ear are not taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back.
After the application time, the skin was washed with water or aqueous solution of a mild detergent. The animals were kept for 3 days and skin changes were
observed on working days. The report describes findings after 24 hours and at the end of the observation period (day 3). In the raw data additional
findings after 48 hours were noted. The data reported were converted from the BASF grading system into the presently used numerical grading system.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h after application
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: questionable reddening
Irritant / corrosive response data:
Application for 5, 15 min or 20 hrs under occlusive conditions induced slight erythema in single animals, application for 1 min. induced no erythema. Edema was not observed in any animal. No irritation detected after 8 days.
Details 20 h exposure, scoring 0, 24, 48, 72 h after patch removal: rabbit No. 1 & 2 no edema at any time point, rabbit No.1 no erythema at any time point, rabbit No. 2 slight erythema (score 1) only 24 h after patch removal (no effects after 48 and 72 h).
Other effects:
There were no clinical signs of systemic toxicity from the dermal exposure.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Only slight reddening of the skin was detected in 1 out of 2 rabbits after dermal exposure to the undiluted test substance.
Executive summary:

Scientifically valid study, but not according to current standards or GLP; partly limited documentation (e.g. no details about the test substance).

Two White Vienna rabbits received a cotton patch (2.5 cm x 2 .5 cm) covered with the undiluted liquid test substance and which was applied under occlusive conditions onto the skin of the back for up to 20 h. Readings were done immediately after patch removal and after 24, 48, 72 h. Application for 5, 15 min or 20 h induced slight erythema in single animals, application for 1 min. induced no erythema. Edema was not observed in any animal. No irritation detected after 8 days.

Conclusion: Only slight reddening of the skin was detected in 1 out of 2 rabbits after dermal exposure to the undiluted test substance.