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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
Principles of method if other than guideline:
Immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin for 24 hours under occlusive conditions.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical appearance: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy
- Weight at study initiation: 2-3 kg
- Housing: individual housing in metal cages
- Diet (ad libitum): rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55+/-10
- Photoperiod (hrs dark / hrs light): 10 h light

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: propylene glycol + saline (70:30)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Concentration (if solution): 50%
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
3 males, 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- Type of wrap if used: gauze patches, covered with an impermeable material and fastened to the body of the rabbit with adhesive tape.

REMOVAL OF TEST SUBSTANCE: after 24 h exposition

SCORING SYSTEM:
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
Total possible erythema score: 4

Edema formation
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: The score was 0 for every animal at any time point on intact skin.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: The score was 0 for every animal at any time point on intact skin.
Irritant / corrosive response data:
The test substance did not elicit any skin reactions when applied to intact skin. All scores in all animals at any time point were zero. Minimal dermal reactions were observed when applied to scarified skin, reversible within 7 days the latest (see table 1 "Any other information on results incl. tables").

Any other information on results incl. tables

Table 1: Individual erythema and edema score after 24, 48, 72 h, 4 d and 7 d at scarified skin:

Exposure time 24 h

Males

Females

 

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

 

24 h

 

 

 

 

 

erythema

1

1

1

1

0

0

edema

0

0

0

0

0

0

           

48 h

 

 

 

 

 

erythema

1

0

0

0

0

0

edema

0

0

0

0

0

0

 

72 h

 

 

 

 

 

erythema

1

0

0

0

0

0

edema

0

0

0

0

0

0

 

4 d

 

 

 

 

 

erythema

1

0

0

0

0

0

edema

0

0

0

0

0

0

 

7d

 

 

 

 

 

erythema

0

0

0

0

0

0

edema

0

0

0

0

0

0

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance has no potency as an irritant to skin, under the test conditions used.
Executive summary:

In a skin irritation study the test item in propylene glycol and saline (70:30) was applied by topical occlusive application to the back of three male and three female adult New Zealand White rabbits. One side of the shaven back was slightly scarified and Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The dressings were removed after a 24 hour application and the skin reaction was appraised at 24, 48, 72 h and after 4 and 7 days on the basis of the Draize soring scheme. To classify the irritating property of the test article, the mean values of erythema and edema formation were calculated for each individual, using the scores between 24 and 72 hours. All scores recorded for the intact skin were zero at any time point in all animals. Minimal dermal reactions were observed when applied to scarified skin, reversible within 7 days the latest. Thus, the test item did not induce significant irreversible damage to the skin and is therefore not regarded as a skin irritant.