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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:
From 18 to 21 January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (B4 Method)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Lot/batch No.: ZJ600
- Expiration date of the lot/batch: January 1995
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 11-14 weeks old
- Weight at study initiation: 2.4 to 3.2 kg
- Housing: individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): standard Iaboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes but no detail

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by means of a time switch to give 12 hours of artificial Iight (0700 - 1900 hours) in each 24 hours period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A 0.5 ml amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
Duration of treatment / exposure:
4 hours
Observation period:
Examination of the treated skin was made on Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Number of animals:
3 rabbits
Details on study design:
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-Iumbar region of each rabbit exposing an area of skin approximately 100 mm x 100 mm.
All animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No erythema was observed
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No oedema was observed
Irritant / corrosive response data:
No dermal irritation was observed.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

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 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid to intact rabbit skin for four hours elicited no dermal irritation. According to these study, 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid is not irritating for skin in rabbits.
Executive summary:

A study was performed to assess the skin irritation potential of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid to the rabbit (Method B.4.). Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for four days. There were no signs of toxicity or ill health in any rabbit during the observation period. No dermal reactions were observed following a single semi-occlusive dermal application of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid to intact rabbit skin for four hours. 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid does not require labelling as lrritating to skin.