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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Aug - Oct 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study tested with the source substance CAS 10043-01-3. 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:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
- Age of animals is not mentioned.
- No initial and confirmatory test.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sulfate d'aluminium en solution
- Physical state: viscous colorless liquid
- Analytical purity: not reported
- Composition of test material, percentage of components: Composition does not add up to 100%: see Confidential details on test material.
- Lot/batch No.: ref. 10-13-14-7-87, received on August 11, 1987
- Storage condition of test material: minimum 19°C
- Other: pH 2,3

Test animals

Species:
rabbit
Strain:
other: Hybrid Albino New-Zealand
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Cleon, France
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: Individual housing, with perforated floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least of 1 week before the beginning of treatment


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12-hour light-dark cycle was maintained (photoperiod 7h30-19h30)


IN-LIFE DATES: From: August 25, 1987 To: August 28, 1987

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: 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): applied as supplied, no further info


Duration of treatment / exposure:
4 h
Observation period:
3 days
Reading time points: 1, 24, 48 and 72 h
- only when severe cutaneous lesions were noted at 72 hours: observations to study possible corrosive actions at day 7 and day 14 (irreversible lesions)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: the test article was applied with a 5 mL sterile polypropylene syringe, directly on the animal skin, on a surface of about 6 cm², and then covered with gauze pad, about 2.4 cm²
- Type of wrap if used: the test article and the gauze pad were kept in contact with the skin with a semi-occlusive patch: 10 cm wide perforated tape (Peloplast) applied on a crimped gauze bandage (Creplux) thus covering the clipped area to avoid possible irritation reactions and wrapped around the animal without blocking the respiratory and abdominal movements.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the bandages were removed and if necessary excess test article which had not penetrated was wiped away with gauze pad moistened with distilled water (or a non-irritant solvent). The animals were then returned to their individual cages.
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No other dermal irritation response was observed in any animal.

Any other information on results incl. tables

Summary of dermal lesions on clipped and intact skin (following 4-h application).

no.

Effect

Hour

Days after application

Mean score erythema

24/48/72 h

Mean score oedema

24/48/72 h

1

1

2

3

7

14

 

 

 

37673

Erythema/ eschar

Oedema

0

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

 

 

0

37680

Erythema/ eschar

Oedema

1

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

0

37681

Erythema/ eschar

Oedema

1

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

0

Mean Group

 

 

 

 

 

 

 

 

0

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
Executive summary:

A primary dermal irritation study was conducted on three male Albino New Zealand rabbits using test substance aluminium sulphate as a solution. The method is according to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.

Each animal received 0.5 ml test material. A single 4 -hour, semi-occluded application of the test material to the intact skin produced immediately after patch removal very slight erythema at the test site of two animal. This effect disappeared after 24 hours after patch removal. Necrosis and ulceration were not reported.

Based on the results of the present study, it was concluded that a solution of aluminium sulfate induced practically no skin irritation, so the test material is classified as non-irritant to the skin. The slight skin effects in two animals are reversible.