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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study under GLP . Deficiency: One animal removed the patch itself before the end of the treatment period; the skin irritation values obtained for this animal are therefore considered to be too low. However, the outcome of the study is not affected.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive dressing)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: melt, yellow to dark yellow

- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, 7 950 Biberach/Riss
- Weight at study initiation: 2470 - 2610 g
- Housing: single
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland (ad libitum)
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: distilled water
Controls:
other: a control gauze patch was applied to the contralateral flank
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (patches were moistened before application with distilled water)
Duration of treatment / exposure:
4 h
Observation period:
1 and 24 hours after removing the gauze patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 12 - 16 cm2
- Type of wrap if used: The patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape
(Isoplast, Isoplast AG, CH-5200 Brugg).


SCORING SYSTEM: according to the OECD scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1 / animal 3)
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
other: TK 11831 induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage.
Remarks on result:
other: One animal removed the patch itself before the end of the treatment period. Therefore the skin irritation values obtained for this animal are considered to be too low and are not included in the calculation of the mean.
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1 / animal 3)
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
other: TK 11831 induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage.
Remarks on result:
other: One animal removed the patch itself before the end of the treatment period. Therefore the skin irritation values obtained for this animal are considered to be too low and are not included in the calculation of the mean.

Any other information on results incl. tables

  erythema edema
animal no. 633 565 625 633 565 625
after 1 hr 4 2 4 2 1 2
after 24 hrs 4 3 4 3 2 3

One animal (No. 565) removed the patch itself before the end of the treatment period period. Therefore the skin irritation values obtained for this animal are considered to be too low.

At the 1 hr-reading a necrotic area (diameter: 1 cm) was observed at the treated skin site of animal No. 565. 24 hours after patch removal the treated skin of animals No. 633 and 625 appeared strongly necrotic and showed black discoloration at a size of approximately 8 x 8 cm (animal No. 633) and 3 x 3 cm (animal No. 625). In animal No. 565 a yellowish discoloration of the skin was seen. Furthermore, at the 24 hours evaluation a slight loss of weight was observed in animals No. 633 and 625.

TK 11831 induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to OECD Guideline No. 404 it has to be concluded that the test substance has corrosive effects in albino rabbits under these test conditions. The test substance has therefore to be classified according to EU (C, R34) and GHS (cat. 1B).