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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
Study period:
January 09 to March 02, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD Guideline 404 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colorless liquid
Details on test material:
See information in the field "Confidential details on test material"

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: L'Abbaye de Bellefontaine, F-49122 Begrolles en Mauges, France
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: Individually in polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 °C
- Humidity (%): 50 ± 20
- 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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1h, 24h, 48 h, and 72 h after exposure termination;
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: right flank
- coverage: 6 cm²
- Type of wrap if used: gauze patch held in place with semi-occlusive dressing

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this assay, the test article has no skin irritating potential.
Executive summary:

DBE has been tested for skin irritation on 3 New Zealand White rabbits according to OECD guideline n° 404 and EU guideline n° B.4 (Draize Method) in compliance with Good Laboratory Practice. The rabbits received a dermal dose of 0.5 ml of DBE on a gauze on intact and abraded skin sites under an semiocclusive dressing for a period of 24 hours. Scores for erythema and oedema were measured 1, 24, 48 and 72 hours after patch removal and primary cutaneous index was calculated (maximum possible index =12)

No sign of dermal irritation (score = 0 for erythema and oedema) was observed for intact skin site of the 3 rabbits at any reading time. Primary Irritation Index was = 0.0. No other signs of intoxication were observed.

Based on these results DBE is not classified irritating to skin according to the criteria of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).