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:
1986
Report Date:
1986

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:
- Name of test material (as cited in study report): Nitrohydrochinondimethylether

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
source of the animals: Hoechst AG breeding colony
weight: 1,8 - 2,2 kg
age: 3 - 5 months
Temperature: 20+-3 °C, humidity: 50+-20%, single cage
light: 12 hours/day
diet: Altromin 2123 ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethylenglycol 400
Controls:
no
Amount / concentration applied:
500 mg substance mixed with 0,2 ml Polyethylenglycol 400
Duration of treatment / exposure:
Duration of treatment was 4 h. After treatment remaining test substance was removed by rinsing with lukewarm water.
Observation period:
72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Other effects:
Time point: 30 - 60 min after patch removal
Effect: Yellow stain of treated skin area due to test substance colour

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.
Executive summary:

Nitrohydrochinondimethylether was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 500 mg test substance mixed with 0,2 ml Polyethylenglycol 400 were applied to the shaved skin of 3 New Zealands White rabbits. After 4 h exposure time the semiocclusive patch was removed. Residual test substance was removed with lukewarm tap water. Animals were examined for signs of skin irritation and/or corrosion at 30-60 min, 24, 48, and 72 h after patch removal. Mean scores (mean of 24, 48, and 72h) were calculated for oedema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.