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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
Study period:
21 Nov - 12 Dec 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study conducted according to the appropriate OECD test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White Russian (Chbb)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Carl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2100 - 2300 g
- Housing: Animals were housed individually in stainless steel cages
- Diet: K4 diet for rabbits (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
21 days
Reading time points: 1, 24, 48 and 72 h and 6, 8, 10, 14, 17 and 21 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal/lateral trunk
- Type of wrap if used: The exposure area (6 cm²) was covered with elastic gauze.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed using warm water after the exposure period.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 17 days
Remarks on result:
other: no eschar formation observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: eschar formation after 72 h, fully reversible within 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: eschar formation after 72 h with detachment within 10 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
Well-defined erythema (grade 2 in 3/3 animals) and edema (grade 1 in 2/3 animals, grade 2 in 1/3 animals) formation was observed in 3/3 animals 1 h after removal of the test material. Moderate to severe erythema (grade 3) formation was observed in the first animal 24 h after removal of the test material but was fully reversible within 17 days. Slight edema (grade 2) formation was observed 24 h after removal of the test material in the same animal, being fully reversible within 6 days. Very slight erythema (grade 1) formation was still recorded in the second animal within 24 h, but was fully reversible within 6 days (including slight eschar formation after 72 h). Very slight edema (grade 1) formation persisted 24 h after removal of the test material and was fully reversible within 48 h. The third animal showed well--defined erythema (grade 2) formation until 72 h after removal of the test material including slight eschar formation after 72 h. Erythema and eschar formation were fully reversible within 8 and 10 days, respectively. Moderate to severe edema (grade 3) formation was observed at the 24 h reading time point but was fully reversible within 6 days.
Other effects:
No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study.

Any other information on results incl. tables

Table 1: Summary of individual skin reaction

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

3

2

1

1

2

3

48 h

3

2

1

0

2

2

72 h

2

2

1

0

2

1

Mean value 24 + 48 + 72 h

2.67

2

1

0.33

2

2

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was tested for skin irritation/corrosion according to the OECD TG 404, but not in compliance with GLP. The undiluted test material was semiocclusively applied to the trunk of 3 male rabbits for 4 h. 1, 24, 48, and 72 h, as well as 6, 8, 10, 13, 17, and 21 days after removal of the test item the skin reactions were recorded. Mean erythema scores over 24, 48, and 72 h noted were 2.67, 1,and 2, respectively, and mean oedema scores were 2, 0.3, and 2, respectively. In one animal showing the strongest erythema reaction, the effect was reversible within 17 days. Hence, the test material was considered to be not irritaing to the skin according to CLP/EU GHS criteria but meets the classification as Category 3 based on GHS criteria.