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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:
weight of evidence
Study period:
25 Oct - 17 Nov 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution

Test animals

Species:
rabbit
Strain:
other: LiIttle russian, Chbb:HM(SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DIMEO Schonwalde GmbH, Schonwalde, Germany and stock Chbb:HM from Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: approx 13 - 15 months
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30% in water
Duration of treatment / exposure:
Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h
Observation period:
14 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: anterior area of the animal
- Type of wrap if used: The patch was placed on the appropriate anterior test field and secured semi-occlusively with adhesive Gothaplast tape (2.5 cm).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure time the patch was removed, the test field was marked and the treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure:
Initial test: 3 min, 1 h and 4 h
Confirmatory test: 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:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 30% (v/v) in water
Irritation parameter:
erythema score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 30% (v/v) in water
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 30% (v/v) in water
Irritation parameter:
edema score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: 30% (v/v) in water
Irritant / corrosive response data:
Initial test:
The animal showed a well defined erythema on the posterior right test field immediately after the application.

Main test:
1 h after the termination of exposure a well defined erythema was observed on the posterior right test field of animal No. 2784. Animals No. 2865 and No. 2866 showed a very slight erythema on the anterior right test fields. 24, 48 and 72 h after the termination of exposure a very slight erythema was observed on the middle right test field of animal No. 2784 as well as a moderate to severe erythema and a very slight oedema on the posterior right test field. Animals No. 2865 and No. 2866 showed a very slight erythema on the anterior right test field. 7 days after the termination of exposure large scales were still observed on the whole posterior right test field of animal No. 2784. Animals No. 2865 and No. 2866 still showed isolated scales on the whole anterior right test fields.
14 days after the termination of exposure animals No. 2784, No. 2865 and No. 2866 were free of any signs of skin irritation.

Other effects:
No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of the initial irritation study.

Exposure time

Erythema formation observed [h]

Oedema formation observed [h]

0

1

24

48

72

0

1

24

48

72

3 min

0

0

0

0

0

0

0

0

0

0

1 h

0

0

1

1

1

0

0

1

1

1

Table 2. Results of skin irritation study.

Observation time

Rabbit no.

 

1

2

3

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

 

1 h

2

0

1

0

1

0

 

24 h

3

1

1

0

1

0

 

48 h

3

1

1

0

1

0

 

72 h

3

1

1

0

1

0

 

Mean value 24 + 48 + 72 h

3,00

1,00

1,00

0,00

1,00

0,00

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified