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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-05-07 to 1985-05-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The translation of the study report is available only. All scientific necessary information for evaluation is available. The study was performed according to OECD guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Praeparat EK, Acetic acid (2-benzothiazolylthione)
- Physical state: white powder
- Purity: 100%
- Purity test date: n.a.
- Impurities (identity and concentrations): n.a.
- Lot/batch No.: n.a.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g/animal
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.
Executive summary:

In order to evaluate the irritant/corrosive potential of the test substance to the skin an in vivo test in rabbits was performed in 1985 which was in accordance to guideline OECD 404. 24 hours prior to treatment the animals back was shaved to receive a skin area of about 10 x10 square centimeters for treatment. Only animals with intact skin were chosen for the test. The 6 animals were each treated with 0.5 g test substance per animal on the right flank, whereas the left side serves as control. The treated area was covered by an occlusive bandage and fixed with a non-irritant tape for 4 hours. After these 4 hours, the bandage was removed and the skin washed with lukewarm water to remove remaining test substance. Mortality and clinical signs of toxicity were observed once daily. The skin was assessed for edema, eschar formation or erythema according to Draize, 60 minutes, 24, 48 and 72 hours after removing of bandage. No mortality occurred. No clinical signs of toxicity were observed. The overall mean scoring value is 0 for erythema and edema formation.

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.