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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
11 Jan 1999 - 11 Mar 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: M.A.F.F. N° 4200 (1985)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01
- Other: pH = 5.8

Test animals

Species:
rabbit
Strain:
other: New Zealand rabbit, NZW I.N.R.A. A9077
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.23-2.40 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet: pelleted complete rabbit diet 112 C-10 (Usine d'Alimentation Rationnelle, Epinay-sur-Orge, France), 150 g/d per animal
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: sterile Codex liquid paraffin
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g prepared as a paste with 0.21 g of sterile Codex liquid paraffin.
The paste was administered within 4 hours of preparation.

VEHICLE
- Amount applied: 0.21 g sterile Codex liquid paraffin
- Lot/batch no.: T0122B
- Expiry date: 1999-12-01
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (about 6 cm²) gauze pad
- Type of wrap if used: the gauze pad was held in contact with the skin with a perforated tape and wrapped with a crimped gauze bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm tap water was used to remove the excess of test article.
- 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:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Other effects:
No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1. Results of skin irritation study

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

1

0

0

0

1

0

0

0

0

0

0

0

24 h

1

0

0

0

1

0

0

0

1

0

1

0

48 h

0

0

0

0

1

0

0

0

1

0

1

0

72 h

0

0

0

0

0

0

0

0

1

0

1

0

Table 2. Calculation of mean scores

 

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value

24 + 48 + 72 h

0.33

0

0

0

0.67

0

0

0

1

0

1

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified