Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13.03.1997 - 07.04.1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: In compliance with GLP, no guidline mentioned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Principles of method if other than guideline:
OECD Principles of Good Laboratory Practice
"Chemikaliengesetz" of the Federal Republic of Germany
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: fluid
Details on test material:
- Name of test material (as cited in study report): AG-EE 623 (S)-Amines
- Physical state:
- Analytical purity: 84.6%
- Composition of test material, percentage of components: batch contains about 15% solvent
- Purity test date: 29.10.1996
- Lot/batch No.: LVE 6005
- Expiration date of the lot/batch: 31.10.1997

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Kar! Thomae GmbH, D-88397 Biberach
- Age at study initiation: 193-224 days
- Weight at study initiation: 3.50-4.14 kg
- Housing: Individual housing in solid wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 45-75%
- Air changes (per hr): maximum 16 x/h
- Photoperiod (hrs dark / hrs light): 15/9 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shorn
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
1h, 24h, 48h, 72h and 7 days
Number of animals:
2 males, 2 females
Details on study design:
TEST SITE
- Area of exposure: 3.0 x 3.0 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
4 h Exposure
Basis:
mean
Remarks:
4 animals
Time point:
other: 1h, 24h, 48h, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Remarks:
4 animals
Time point:
other: 1h, 24h. 48h, 72h
Score:
0
Max. score:
0

Any other information on results incl. tables

Evaluation of the skin reactions according Draize scale ("Bundesgesetzblatt", Part 1, No. 57, dated December 24, 1981)

Slight erythemas were found at the administration sites of all animals from 1 hour until 72 hours after administration. The erythemas disappeared until day 7 of the experiment. No substance-related systemic toxic effects and no effect on food or water consumption were observed by visual inspection.

Applicant's summary and conclusion

Interpretation of results:
other: R38
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Since erythemas were found at the administration sites of all animals for more than 72 hours,
the test substance AG-EE 623 (S)-Amines, a chemical intermediate of AG-EE 623 ZW, is
considered to be skin irritating (R38).