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:
1990
Report Date:
1990

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
Details on test material:
purity: 94.5% contains residual water

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 months
- Weight at study initiation: 3.4 - 4.0 kg
- Housing: single cages in completely air conditioned rooms
- Diet: Altromin 2123 ad libitum and 15 gr hay per day
- Water: deionized and chlorinated water from automatic dispensored ad libitum


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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg test substance mixed with 0.8 ml physiol. saline
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: adhesive plaster from Beiersdorf, Hamburg, wrapped witha semiocclusive bind.

REMOVAL OF TEST SUBSTANCE
- Washing : with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 7, 8, 9 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: no signs of irritation at any time
Irritation parameter:
edema score
Basis:
animal: # 7, 8, 9 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: no signs of irritation at any time
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
During the entire test no signs of irritation occured. Therefore, the substance was considerd not to be skin irritating.
Executive summary:

The substance was tested for skin irritation according to OECD guideline 404. 3 New Zealand albino rabbits were treated with

500 mg of the test item mixed with 0.8 ml physiol. saline. After 4 hours exposure time the substance was removed by washing with lukewarm tap water. The observation period was 72 h. No signs of irritation were observed at any point in time of observation.