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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: Study was not conducted in compliance with GLP, but is well documented and sufficient to cover this endpoint (conduction close to OECD 404).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure, occlusive
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 1%
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6
Details on study design:
Prior to treatment the hair was closely clipped off from the back of the animals. On each of the rabbits two areas of the back ware designated for the position of the patches. One of the areas was abraded by making epidermal incisions. The patches consisted of two 2.5 cm squares of double layer
light gauze and were secured to the test areas by adhesive tape.
A volume of 0.5 ml of the diluted test compound has been applied under each of the patches. The entire trunk of the rabbits was wrapped in a rubber
sleeve and the animals were immobilized for 24 hours in wooden stocks. 24 hours after application the patches were removed and the resultIng
reactions scored according to the Draize's scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Within 24 hours after application very slight erythema of both abraded and intact skin was observed in four animals. At the 72-evaluation this skin alteration were absent. The primary irritation index was 0.34 and therefore the test item is not considered to be irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
A 1% aqueous solution of "CHR 5" has been evaluated in the primary skin irritation test in rabbits. Under the described conditions of this study in the rabbit the test item was not irritating to the skin.