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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: older study; not conducted in accordance with current GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
guinea pig
Strain:
Hartley

Test system

Type of coverage:
occlusive
Preparation of test site:
other: depilated using barium sulfide/talc/starch/commercial laundry detergent
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
1, 5, 10, 20 mL/kg
Number of animals:
six
Details on study design:
The abdomens of six guinea pigs were depilated. Following depilation, the animals were exposed dermally to doses of 1 (one animal), 5 (one animal), 1 0( one animal), or 20(three animals) mL/kg for 24 hours via gauze pads to which the appropriate amount of test substance had been applied. The pads were held in place by impervious rubber dental dam material wrapped around the torso of the animal and secured with rubber cement. The skin was evaluated immediately after removal of the wrapping material and one and two weeks later

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
other: 14 days
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
At initiation of the study, the guinea pigs weighed between 475 and 593grams. Immediately after the animals were unwrapped, clinical signs of irritation on all six animals included moderate to severe erythema, moderate to gross edema and some evidence of necrosis. At one week, thin, dried eschars covered the entire area of the application site for all six animals. By termination of the 14-day study, the application sites had small, scattered light eschars, desquamation, alopecia, and light scarring. The severity of the signs was not related to dose. All animals gained weight during the study.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance was rated a moderate irritant under the conditions of this study
Executive summary:

A screening study was conducted in six guinea pigs to estimate dermal irritation, dermal toxicity, and dermal absorption of the test substance. In this study the abdomens of six guinea pigs were depilated using a depilatory containing barium sulfide, talc, starch, and a commercial laundry detergent, wetted to make a thin paste. Following depilation, the animals were exposed dermally to doses of 1 (one animal), 5 (one animal), 1 0( one animal), or 20(three animals) mL/kg for 24 hours via gauze pads to which the appropriate amount of test substance had been applied. The pads were held in place by impervious rubber dental dam material wrapped around the torso of the animal and secured with rubber cement. At initiation of the study, the guinea pigs weighed between 475 and 593 grams. The skin was evaluated immediately after removal of the wrapping material and one and two weeks later. Immediately after the animals were unwrapped, clinical signs of irritation on all six animals included moderate to severe erythema, moderate to gross edema and some evidence of necrosis. At one week, thin, dried eschars covered the entire area of the application site for all six animals. By termination of the 14-day study, the application sites had small, scattered light eschars, desquamation, alopecia, and light scarring. The severity of the signs was not related to dose. All animals gained weight during the study. The test substance was rated a moderate irritant under the conditions of this study,