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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
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:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 198 1
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
September 19, 1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler ; D-W6050 Offenbach, FRG
- Age at study initiation: young adult
- Weight at study initiation: 2.43 - 2.60 kg
- Housing: single, in stainless steel cages (40 cm x 51 cm)
- Diet (e.g. ad libitum): KLIBA diet 341 ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: > 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml

Duration of treatment / exposure:
4h
Observation period:
72h (study terminated after 72h since no irritation was observed)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): polyethylenglycol and polyethylenglycol / water (1:1)
- Time after start of exposure: 4h

SCORING SYSTEM:
according to Draize (and as documented in OECD Guideline 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Mean individual scores : 0 - 0.33 - 0.33
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Mean individual scores = 0 - 0 - 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not skin irritating
Conclusions:
Based on the conditions of this study, the substance is not classified as irritating to the skin according to CLP classification criteria.
Executive summary:

The potential of butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 rabbits for 4 hours under semiocclusive dressing. The average score (24-48-72h) for irritation was calculated to be 0.2 for erythema and 0 for edema. The skin reactions were reversible within 48 hours, thus the study was terminated 72h after application. Under the test conditions chosen and considering the described findings, butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate does not give indication of an irritant property to the skin.