Registration Dossier

Toxicological information

Skin irritation / corrosion

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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 and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

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)
GLP compliance:
yes (incl. certificate)
Remarks:
Harlan Laboratories Ltd

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification : Propylene oxide
Description : clear colourless liquid
Batch number : S-122009-310041
Date received : 14 December 2009
Expiry date : 14 June 2010
Storage conditions : room temperature in the dark
Analytic purity: 99.98%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Harlan Laboratories UK Ltd, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12-24 weeks
- Weight at study initiation: 2.49 or 2.65 kg
- Housing: individually
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24 ,48 and 72 hours after removal of patch
Number of animals:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: the individual score was 2 for one rabbit only
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: one rabbit scored 1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 and 72 hours
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information