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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 August 11 to 14, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Individual animal weights not reported
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of acrylic acid and 4,4'-isopropylidenediphenol ethoxylated
EC Number:
701-362-9
Molecular formula:
(C2 H4 O)x (C2 H4 O)y C21 H20 O4
IUPAC Name:
Esterification products of acrylic acid and 4,4'-isopropylidenediphenol ethoxylated
Details on test material:
SID Change
Previous CAS: 64401-02-1
Previous EC: 613-584-2

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Hampshire, England
- Age at study initiation: Approximately 10-11 weeks
- Weight at study initiation: 2.3-2.6 kg
- Housing: Housed individually in metal cages
- Diet: Standard laboratory diet (SDS Stanrab (P) Rabbit diet), ad libitum
- Water: Drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30-70 %
- Air changes: Approximately 19 air changes/h
- Photoperiod: 12 h dark / 12 h artificial light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
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 h
Observation period:
4 days [Day 1 (approximately 60 min after removal of the dressings) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h after exposure)]
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: Test substance was applied under a 25 mm X 25 mm gauze pad to one intact skin site on each animal.
- Type of wrap if used: Treatment site was covered with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: After 4 h of exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30-40 °C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

SCORING SYSTEM:
- Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout the observation period.
Other effects:
No signs of toxicity were observed in any animal throughout the observation period.

Any other information on results incl. tables

Table 1: Dermal reactions observed after application of SR 349

Rabbit number and sex (male)

E = Erythema

O = Oedema

Day

1*

2

3

4

2268

E

0

0

0

0

O

0

0

0

0

2269

E

0

0

0

0

O

0

0

0

0

2270

E

0

0

0

0

O

0

0

0

0

 

* Approximately 30 minutes after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance is not classified as irritating to skin.
Executive summary:

In a primary dermal irritation study performed similarly to OECD Guideline 404 and in compliance with GLP, three New Zealand White male rabbits were dermally exposed to 0.5 mL of the test substance, under a semi-occlusive patch (25 mm X 25 mm) for 4 h to intact clipped skin of the dorso-lumbar region. After removal of the residual test material, animals were observed for 4 days. Irritation was scored by the method of Draize at Day 1 (approximately 60 min after removal of the dressings) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h) after exposure.

No dermal reactions and signs of toxicity to treatment were observed in any animal throughout the observation period. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were respectively 0, 0, 0 for erythema and 0, 0, 0 for oedema score. In this study, the test substance is not a skin irritant on male rabbits.

 

Under the test conditions, the test substance is not classified as irritating to skin.