Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.10. - 11.11.1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
OECD Guideline study before 2002, GLP. In deviation from the current OECD 404 guideline the test substance was applied to an area of 12-16 cm² and not 6 cm² as recommended, further, no information on removal of residual test substance after the exposure period is available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical properties: liquid
- Storage conditions: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2470 to 2620 g
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 22.10. to 01.11.1991

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: A control gauze patch moistened with distilled water was applied to the contralateral flank.
Amount / concentration applied:
0.5 mL of the test substance were applied (unchanged)
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches. The observation period was extended to 10 days to determine the reversibility of the skin reactions.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: right flank, approx. 12-16 cm²
- Type of wrap if used: The gauze patch was loosely covered with an aluminium foil (approx. 36 cm²) and held in place for 4 hrs by an adhesive tape.

SCORING SYSTEM:
The skin reactions were evaluated 1, 24, 48, 72 hours and on day 7 and day 10 after removing the gauze patches according to the OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24-72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Erythema Score 1 and scaling after 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24-72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Erythema Score 1 and scaling after 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Erythema Score 1 and scaling after 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Edema Score 1 after 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Edema Score 1 after 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Erythema and edema were observed already at the 1 hour time point. From the reading one hour up to 72 hours after patch removal the erythema reaction was extending beyond the application area in all animals. The skin reactions observed were reversible until the end of the observation period on day 10.
Other effects:
Scaling was seen on day 7 in all animals. A loss of body weight was recorded in one animal on day 3.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the experimental conditions employed the test article induced erythema and edema reactions when applied to the clipped albino rabbit skin at levels above the threshold of significance and must therefore be classified as irritant to the skin.
Executive summary:

In an acute dermal irritation study following OECD guideline 404 and in compliance with GLP, three rabbits were exposed to 0.5 ml of the test substance for 4 hours. The test substance was applied unchanged to a gauze patch (12 -16cm²) which was applied to the shaved right flank of each animal. The gauze patch was loosely covered with an aluminium foil (approx. 36 cm²) and held in place for 4 hrs by an adhesive tape. A control gauze patch moistened with distilled water was applied to the contralateral flank. Observations were made 1, 24, 48 and 72 hours after removal of the gauze patches. Erythema and edema were observed already at the 1 hour time point. From the reading one hour up to 72 hours after patch removal the erythema reaction was extending beyond the application area in all animals. Scaling was seen on day 7 in all animals. A loss of body weight was recorded in one animal on day 3. The skin reactions observed were reversible until the end of the observation period on day 10. Based on the results the test article is regarded as irritating to the rabbit skin and has to be classified.