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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:
1989-09-12 to 1989-09-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD and GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981-05-12
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test item contains about 38 % water. Reason is that this compound is manufacturer and further processed only as water wet substance.
It is not expected that the additional amount of water has an influence on the results.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.3-3.4 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, Altromin GmbH, ad libitum and hay, 15 g daily
- Water (e.g. ad libitum): deionised, chlorinated water from automatic feeder, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
500 mg Aminolon TF in 0.2 ml 0.9% NaCl solution
Duration of treatment / exposure:
4 hrs, after application residual test substance was removed by rinsing with lukewarm tap water
Observation period:
Observations at 30-60 min, 24, 48 and 72 hrs after removal of test substance
Number of animals:
3
Details on study design:
Area of exposure: 2.5 x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of animal # 111, 112, 113 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: no effects at any time
Irritation parameter:
edema score
Basis:
other: mean of animal # 111, 112, 113 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: no effects at any time
Irritant / corrosive response data:
No signs of irritation/corrosion have been observed during the entire study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Not irritating
Executive summary:

The test item was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 500 mg Aminolon TF mixed with 0.2 ml physiol. saline were applied to the shaved skin of New Zealand White rabbits. After 4 h exposure time the semiocclusive covering was removed and remaining substance was removed by rinsing with tap water. Mean scores (mean of 24, 48, 72h) were calculated for oedeme and erythema for each rabbit.

No signs of irritation have been observed during the entire study period. Based on these findings the test substance is neither skin irritating nor skin corrosing in this test.