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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:
22 to 25 February 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study well conducted.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): ALUM - 17. Aluminium sulphate containing 17% w/w Al2 O3
- Physical state: white powder
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: approximately twelve to sixteen weeks old.
- Weight at study initiation: 2.24 - 2.68 Kg.
- Housing: individually
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Limited.
- Water (e.g. ad libitum): drinking water
- Acclimation period: five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 68 - 74%
- Air changes (per hr): 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.

IN-LIFE DATES: no data.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the patches removal.
Number of animals:
Three (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
- % coverage: the patch was secured in position with a strip of surgical adhesive tape (BLENDER: approximate size 2.5 cm x 4.0 cm)
- Type of wrap if used: elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize method.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
None
Other effects:
no data

Any other information on results incl. tables

Table 7.3.1/1: Individual Skin Reactions

Skin Reaction

Observation Time

(following patch

removal)

Individual Scores – Rabbit Number and Sex

145 Male

146 Female

148 Female

Erythema/Eschar

Formation

Immediately

0

0

0

1 h

0

0

0

24 h

0

0

0

48 h

0

0

0

72 h

0

0

0

Mean (24, 48 and 72 h)

0.0

0.0

0.0

Oedema

Formation

Immediately

0

0

0

1 h

0

0

0

24 h

0

0

0

48 h

0

0

0

72 h

0

0

0

Mean (24, 48 and 72 h)

0.0

0.0

0.0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions of this study, the test material ALUM-17 was found to be non-irritant to the rabbit skin. Therefore, no classification is required according to EU criteria.
Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand White rabbits were dermally exposed to 0.5 g of ALUM-17 as a powder (analytical purity of min. ) moistened with distilled water (0.5 mL) under a semi-occlusive dressing for 4 h. After removal of the residual test item, skin irritation was scored by the method of Draize (1959) at 24, 48 and 72 h after exposure.

No skin responses were noted during the study. All treated skin sites appeared normal at the 24 h observation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for erythema and 0, 0, 0 for oedema score, respectively. In this study, ALUM-17 is therefore not a skin irritant on rabbits.

Under the test conditions, Aluminium sulphate is not classified as irritating to skin according to the Regulation (EC) N° 1272 -2008 (CLP) and the Directive 67/548/EEC criteria.

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