Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
well performed GLP and OECD guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
directive 83/467/EEC
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2,8 kg to 3,0 kg
- Housing: Individually in stainless steel cages, air-conditioned
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, 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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test substance mixed with 0.5 mL physiologic saline
Duration of treatment / exposure:
Duration of treatment was 4 hours. After treatment residual test substance was removed with lukewarm tap water.
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm (are was shaved appr. 24 hours prior to administration)
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the findings in this test, the test item is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline 404. The test item was applied by topical semi-occlusive application of 0.5 g test item mixed with 0.5 mL physiologic saline to the intact shaved skin of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.

No signs of irritaion were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce damage to the skin. Based on that, the test item is considered to be "not irritating" to rabbit skin.