Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
22 to 25 December 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP-compliant proprietary study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Ethyl butyl propanediol
- Physical state: colourless crystalline powder
- Analytical purity: 98.2%
- Storage conditions: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Rabbits were supplied by Rosemead Rabbits, Waltham Abbey, Essex, England. They were 10 to 13 weeks old and in a weight range of 2.4 to 2.7 kg, prior to treatment on Day 1. The animal room temperature was maintained at 19°C with a relative humidity at 30-70%. Air exchange was maintained at 19 air changes/hour and lighting was controlled to give 12 hours of artificial light in each 24 hour period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
The dermal test site was shaved 24 hours prior to application. The test material was moistened with distilled water. At completion of exposure, the bandages were removed and the sites were washed with water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Very slight erythema only persisted in 1 animal on Day 2.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Very slight oedema achieved on Day 1 only.
Irritant / corrosive response data:
Effects were transient and reversible.
Other effects:
None reported

Any other information on results incl. tables

The test material induced very slight erythema and oedema in all animals. One animal was observed with very slight erythema on Day 2. All reactions had resolved by Day 2 or 3.

Rabbit number

E = Erythema

O = Oedema

Day

1*

2 (24 h)

3 (48 h)

4 (72 h)

1828F

E

1

0

0

0

O

1

0

0

0

1829F

E

1

1

0

0

O

1

0

0

0

1830F

E

1

0

0

0

O

1

0

0

0

* Approximately 30 minutes after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
BEPD was found to be a transient skin irritant under the conditions of this study. Mean scores for the 24-72 hour assessments did not exceed EU classification thresholds.
Executive summary:

0.5 g of the test material (moistened with distilled water) was applied for 4 hours under semi-occlusive conditions to the shorn dorsal skin of three New Zealand White Rabbits. Exposure to the test material was terminated by washing the skin with water. Local dermal irritation was assessed at 1, 24, 48 and 72 hours. Very slight erythema and oedema were observed at the 30 minute reading in all three animals. Very slight erythema only persisted in one animal on Day 2. All reactions had resolved by Day 2 or 3. BEPD was found to be only minimally irritant under the conditions of this study.