reaction products of 1,4-butanediol with 1,3-chloro-2,3-epoxypropane, esters with prop-2-enoic acid

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 198 1

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

September 19, 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of butane-1,4-diol and 1-chloro-2,3-epoxypropane, esters with acrylic acid

EC Number:

701-230-0

Cas Number:

52408-42-1

Molecular formula:

C16H26O8

IUPAC Name:

Reaction products of butane-1,4-diol and 1-chloro-2,3-epoxypropane, esters with acrylic acid

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system 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

Results

Results 1

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

Results 2

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.