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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 Jan, 1994 to and 21 Jan, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[[3-hydroxy-2,2-bis[[(1-oxoallyl)oxy]methyl]propoxy]methyl]-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate
EC Number:
800-838-4
Cas Number:
1384855-91-7
Molecular formula:
Molecular formula not available for this UVCB.
IUPAC Name:
2-[[3-hydroxy-2,2-bis[[(1-oxoallyl)oxy]methyl]propoxy]methyl]-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SR399
- Physical state: Viscous liquid
- Purity: Not known to HRC
- Lot/batch No.: HYH1309
- Expiration date of the lot/batch: January 1995
- Storage condition of test material: Room temperature in the dark
- Date received: 14 December 1993

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., Petersfield, Hampshire, England
- Age at study initiation: Approx 17 to 19 weeks
- Weight at study initiation: 3.7 to 4.0 kg
- Housing: Individually in plastic cages with perforated floors in Building R 14 Room 1.
- Diet: SDS Stanrab (P) Rabbit Diet ( ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70%
- Air changes: 19 air changes/h
- Photoperiod: 12 h of artificial Iight (0700 - 1900 h) in each 24 h period

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
4 d
Number of animals:
3
Details on study design:
Approx 24 h prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approx 100 mm x 100 mm. 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 4 h. 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 3 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 3 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 3 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritant / corrosive response data:
Very slight erythema was seen in all three animals on Days 1 and 2. The skin were normal on Day 3.

Any other information on results incl. tables

Dermal reactions observed after application of the test substance:

Rabbit number and sex

E=Erythema

O=Oedema

Day

1

2

3

4

 

2945 (male)

E

O

1

0

1

0

0

0

0

0

2946 (male)

E

O

1

0

1

0

0

0

0

0

2947 (male)

E

O

1

0

1

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: EU CLP criteria not met
Conclusions:
Under the study conditions, the test substance was determined to be not irritating to the skin.
Executive summary:

A study was conducted to determine the skin irritation potential of test substance, DPHA to rabbit according to EU Method B.4, in compliance with GLP. Three rabbits were administered a single dermal dose of 0.5 mL under semi-occlusive dressing for 4 h. 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 to remove residual test substance. The treated area was blotted dry with absorbent paper. All animals were observed daily for signs of toxicity and ill health. Examinations of treated skin were made on Day 1 (60 mins after removal of dressing), and on Days 2, 3 and 4 (i.e., 24, 48 and 72 h after exposure). Dermal irritation was assessed using the numerical grading system. Very slight erythema was seen in all three animals on Days 1 and 2. Skin was normal on Day 3. Under the study conditions, the test substance was determined not to be irritating to the skin (Parcell, 1994).