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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:
weight of evidence
Study period:
1975, not specified
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study is old data conducted to no recognised test guideline. The data are reported in a brief resume of the test and observations.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500.41
Deviations:
not specified
Principles of method if other than guideline:
The acute skin irritation test was conducted on 6 adult albino rabbits selected from healthy, acclimated animals. The method employed is patterned after the Draize procedure as described in 16 CFR 1500.41 . The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. The material (0.5 ml or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch. Patches were removed after 24 hours and observations recorded. Observations were again made after 72 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Specified only as Product No . X-50; Kronitex 50 ; Lot 5-101.
No other information on the test material is provided within the report.

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals and environmental conditions:
6 adult albino rabbits selected from healthy, acclimated animals. No other information is detailed.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: One side shave and one side abraded.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml or 0.5 g
Duration of treatment / exposure:
24 hours.
Observation period:
72 hours.
Number of animals:
6
Details on study design:
The acute skin irritation test was conducted on 6 adult albino rabbits selected from healthy, acclimated animals. The method employed is patterned after the Draize procedure as described in 16 CFR 1500.41 . The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. The material (0.5 ml or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch. Patches were removed after 24 hours and observations recorded. Observations were again made after 72 hours.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritant / corrosive response data:
No erythema or edema were observed.
Other effects:
None

Any other information on results incl. tables

Table 1

Findings

Exposure Time (Hours)

Exposure Unit

Rabbit No

Erythema and eschar formation:

 

1

2

3

4

5

6

Intact Skin

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Abraded Ski

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Subtotal

 

0

0

0

0

0

0

 

 

 

 

 

 

 

 

Edema formation:

 

 

 

 

 

 

 

Intact Skin

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Abraded Ski

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Subtotal

 

0

0

0

0

0

0

 

 

 

 

 

 

 

 

Score

 

0

0

0

0

0

0

Average:

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the data presented herein, the test material, is not an irritant to the rabbit skin. This material is not considered a corrosive substance.
Executive summary:

The test sample was exposure to the backs of 6 albino rabbits; theback of each animal was previously shaved free of hair. Intact skin was exposed on the left half of the shaved area, and the abraded on the right half. No skin reactions were observed over a 72 hour review period and the test sample is considered to be non-irritating.

On the basis of the data presented herein, the test material is not an irritant to the rabbit skin . This material is not considered a corrosive substance.