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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch number: sample no.1
- Purity: 90.5 %
- Before the treatment, the test substance was stored at -20°C and protected from light and was stored at +4 °C during the treatment
- The pH of the test substance specified in the test article description was between 5 and 7.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: New-Zealand albino
- Sex: male
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel, France)
- Age: no data
- Weight at study initiation: 2.4 ± 0.1 kg
- Controls: auto-control (left flank)
-Upon their arrivai at C.I.T., the animals were acclimatized to the experimental environment for at least 5 days during which they were observed daily.
-They were individually identified with metallic ear-tags.

ENVIRONMENTAL CONDITIONS
- Temperature : 22 ± 3°C
- Humidity : 50 ± 20% relative humidity
- Light/dark cycle: 12 hours of light/12 hours of dark
- The air was non-recycled and filtered by absolute filters.
- Food and water: ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: none
Controls:
other: The left flank did not receive any substance and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL:
- Concentration : undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
The cutaneous reactions were evaluated one hour then 24, 48 and 72 hours after removal of the semi-occlusive dressing and then daily until day 15.
Number of animals:
3
Details on study design:
- Area of exposure: right flank, 6 cm2
- Total quantity applied: 0.5 ml
- Administration frequency: once
- Removal of test substance: no
EXAMINATIONS:
- Scoring system: Draize's score
- Examination time points: 1h, 24 h, 48 h and 72 hours after the patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1 and 2
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Desquamation up to d15
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Desquamation up to d15
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal: 2 and 3
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
A marked skin inflammation (erythema: mean scores of 2.7 to 3.0 and oedema: mean scores of 2.0 to 2.7) was observed during at least 72 hours. Reversibility of the oedema was recorded on day 7 and erythema was no longer observed on day 10. Between days 7 and 15, desquamation of the skin, signs of superficial reversible damages of the skin were observed in the 3 animals

Any other information on results incl. tables

 No residual test substance was observed after removal of the dressing.

Mean calculated score for each site

Observation period (hours) 

1       24      48        72   

Erythema   3,0     3,0     3,0       2,7 

Oedema        3,0     3,0     2,7       1,7   

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Executive summary:

The skin irritation potential of 3-hydroxy-1,1-dimethylbutylperoxy-neodecanoate was assessed in a skin irritation test conducted according to the OECD 404 guideline (GLP study)

A single dose of 0.5 ml of the test substance in its original form was prepared on a dry compress then applied to a 6 cm2 clipped areas of 3 male New Zealand White rabbits. The test substance was held in contact with the skin for 4 hours by means of a semi-occlusive dressing. The cutaneous reactions were observed one hour, 24, 48 and 72 hours after removal of the dressing and then daily until day 15. No residual test substance was observed after removal of the dressing. The mean score of the scores recorded after 24, 48 and 72 hours for each animal was calculated.

A marked skin inflammation (erythema: mean scores of 2.7 to 3.0 and oedema: mean scores of 2.0 to 2.7) was observed during at least 72 hours. Reversibility of the oedema was recorded on day 7 and erythema was no longer observed on day 10. Between days 7 and 15, desquamation of the skin, signs of superficial reversible damages of the skin were observed in the 3 animals. In conclusion the test substance was considered as irritant when administered by cutaneous route in rabbits.