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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: Longer duration of exposure (24 versus 4 hours); no detail on pH of test substance; limited detail on characteristics of the test substance.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ALON (aluminium oxide or fumed alumina)
- Physical state: white powder with faint odour)
- Analytical purity: close to 100%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Age: not reported
Sex: not reported
Weight: not reported

Environmental/Housing conditions:
No information provided.

Acclimation: No information was provided.

Feeding conditions:
This information was not provided.

Test system

Type of coverage:
other: wrapped with binders of rubber dam
Preparation of test site:
other: intact and abraded skin
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
-Concentrations: 0.5g in 1.0mL = 500g/L (50%)
-Volume: 1.0 mL
-Area: the substance was under a 1 inch square patch.
Duration of treatment / exposure:
A single, 24 hour dermal application was made.
Observation period:
Observations were made at 24 and 72 hours.
Number of animals:
Three animals with intact skin and three animals with abraded skin
Details on study design:
One-inch square gauze patches were applied to pre-moistened, clipped intact or abraded skin on the back of the animals, wrapped with binders of rubber dam and immobilised for the exposure period.

The scoring system used was that of Draize (1959) and was provided in the report:
Evaluation of Skin reactions
Erythema and eschar formation:
No erythema, Score = 0
Very slight erythema (barely perceptible), Score =1
Well-defined erythema, Score=2
Moderate to severe erythema, Score=3
Severe erythema (beet redness) to slight eschar formation (injuries in depth), Score =4

Edema formation:
No edema, Score=0
Very slight edema (barely perceptible), Score=1
Slight edema (edges of area will defined by definite raising), Score=2
Moderate edema (raised approximately 1.0mm)
Severe edema (raised more than 1.0mm extending beyond the area of exposure), Score=4

-“Values for erythema and eschar formation at 24 hours and 72 hours for intact skin animals will be added to the values on abraded skin animals at 24 and 72 hours. Similarly, the values for edema formation at 24 hours and at 72 hours for the intact and abraded skin animals will be added. The primary irritant score is the total of the eight values divided by four. A primary irritant is one which results in a score of five or more as tested by this method.”

The pH of the test substance was not measured.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Other effects:
Clinical signs of toxicity were not reported.

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:
The results from the study are negative and would not lead to classification.

Executive summary:

A study conducted at Hazleton Laboratories Inc. for the Cabot Corporation investigated dermal irritation effects of ALON, a fumed alumina produced by the chemical hydrolysis of aluminium chloride, in New Zealand White rabbits. 0.5g of the substance in 1.0mL of distilled water was applied to pre-moistened skin on the backs of 6 rabbits under gauze patches. Three of the rabbits had abraded skin and three intact skin. The patches remained place for 24 hours. Lesions were scored at 24 hours and at 72 hours using the scoring criteria of Draize (1959). The report lacks detail on animal husbandry and signs of toxicity. Further details of the test substance characteristics were obtained from the study sponsor. The results showed slight erythema in all three rabbits with abraded skin at 24 hours. The erythema had resolved by 72 hours. No erythema was observed in the animals with intact skin. No animal exhibited edema. The overall primary irritation score from the study (0.25) would not lead to classification.