Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
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:
TEST ANIMALS
- Source: HOECHST AG, company breeding colony
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.1 - 3.4 kg
- Housing: AC, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen ad libitum, 15 g hay per day
- Water (e.g. ad libitum): deionised, chlorinated water from an automatic water dispenser ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- 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
- Concentration (if solution): 500 mg of test material mixed with 0.25 ml physiol. saline

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 ml physiol. saline
- Concentration (if solution): 500 mg of test material mixed with 0.25 ml physiol. saline
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: adhesive plaster covered by a bandage

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

SCORING SYSTEM:
Erythema: 0-4
Edema: 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 12, 13, 14 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Irritation parameter:
edema score
Basis:
animal: # 12, 13, 14 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritant, not corrosive to skin

Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008.

Executive summary:

Skin irritation/corrosion was tested according to OECD guideline 404. Following this protocol the test item (0.5 g mixed with 0.25 ml physiol. saline) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four houres. The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the test item. No skin reactions, neither erythema nor edema, were observed at any time point (all scores 0). No signs of sytemic toxicity were reported.