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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:
key study
Study period:
February-March 1985
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Rationel for reliability: No data on batch no. and composition. Basic data reported, according to guidelines/standards (max score can be 2). Rationale for read-across: The registration substance and the read-across supporting substance belong to the category "Primary Fatty Amine Ethoxylates"

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observation 30 min after patch removal rather than at 60 min
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Appearance: yellow liquid
Date of receipt: 14 February 1985
Storage: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield abbits, Petersfield, UK
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.7-3.0 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes, but period not indicated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19
- Humidity (%): 30-70%
- Air changes (per hr): ca. 19
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 26 February To: 11 March 1985

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 (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
13 days (study started on day 1 and ended on day 14).
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze pad
- % coverage: area of 10 cm square was shaved; therefore ca. 60%
- Type of wrap if used: Elastoplast elastic adhesive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Remarks:
within 13 days
Remarks on result:
other: persistent eryhthema
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
2.89
Max. score:
3
Reversibility:
not reversible
Remarks:
within 13 days
Remarks on result:
other: persistent oedema
Irritant / corrosive response data:
Very slight erythema and oedema were observed in all three animals following removal of the bandages. By the following day well-defined to severe erythema with necrotic areas and moderate oedema had developed. These reactions persisted during Week 1 of observation. Persistent moderate erythema and oedema with hyperkeratinization and desquamation of the stratum corneum was seen during Week 2. By Day 14 (13 days after application) the dead skin had completely sloughed, revealing new skin.
Other effects:
No data

Any other information on results incl. tables

Summary of dermal irritation (following 4-h application)

Animal no.

Effect

Hour

Days after application

Mean score erythema

(24/48/72 h)

Mean score oedema

(24/48/72 h)

0.5 h

1

2

3

7

13

2113F

Erythema

Oedema

1

1

2

3

2

2

2

3

3B

3

2C

2

2

2.67

2132M

Erythema

Oedema

1

1

4A

3

4A

3

4A

3

3B

3

2C

2

4

3

2133M

Erythema

Oedema

1

1

4A

3

4A

3

4A

3

3B

3

2C

2

4

3

Mean all animals

3.33

2.89

Additional observations were made on days 4-6 and 8-12.

A=necrotic areas, B=hyperkeratinisation, C= new skin

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The skin irritation property of the registration substance is derived based on the read-across approach.
The read-across supporting substance CAS 71786 -60 -2 was investigated for its irritancy potential to the skin in rabbits according to the OECD 404. Clear corrosive effects were found.
Executive summary:

The skin irritation property of the registration substance is derived based on the read-across approach.

The read-across supporting substance CAS 71786 -60 -2 was investigated for its irritancy potential to the skin in rabbits according to the OECD 404 . A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced persistent moderate to severe irritation. The test material was therefore classified as corrosive (Category 1C) according to OECD-GHS.