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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (EU Method B.4 and OECD 404).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Eu Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethoxypropyl acetate
- Physical state: Liquid
- Analytical purity: > 98.5%
- Storage condition of test material: At ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Each animal was identified by a numbered aluminium tag placed through the edge of one ear.
- Source: Rosemead Rabbits, Rosemead, Essex, UK
- Age at study initiation: Approximately 10 to 11 weeks
- Sex: males
- Weight at study initiation: 2.2 to 2.5 kg
- Housing: Individually in metal cages with perforated floors
- Diet: Ad libitum access to SDS Standard Rabbit Diet
- Water: Ad libitum access to tap water
- Acclimation period: Animals were acclimated to the laboratory environment (period not stated)

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 degrees C
- Humidity: 30 – 70 % relative humidity
- Air changes: Approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light (0700-1900 hours) in each 24 hour period.

IN-LIFE DATES: From: 30 July, 1985 To: 2 August, 1985

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:
Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches), and on Days 2, 3 and 4.
Number of animals:
Three.
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square
- % coverage:
- Type of wrap if used: Guaze pad occluded with ‘Elastoplast’ elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water
- Time after start of exposure: 4 hours after treatment

SCORING SYSTEM:
Erythema and eschar formation (Grades 0 – 4)
Oedema formation (Grades 0 – 4)
Other lesions described

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72hrs
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Mean of 3 animals tested. Maximum score observed 1.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72hrs
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Mean of 3 animals tested. Maximum score observed 1.
Irritant / corrosive response data:
Very slight (Grade 1) erythema, with or without very slight oedema was seen in two animals on Days 2 and 3 only. These responses were completed resolved on Day 4. The remaining animal showed no observable response to treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of ethoxypropyl acetate to intact rabbit skin for 4 hours elicited very slight dermal irritation. Based on these results, ethoxypropyl acetate is not classified as an irritant, and does not require labeling with risk phrase R38: ‘Irritating to skin’.
Executive summary:

In a guideline and GLP in vivo rabbit skin irritation study, a single semi-occlusive application of ethoxypropyl acetate for 4 hours elicited very slight dermal irritation. The response was well below the threshold for classification as a skin irritant.