ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 to 19 September 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Proprietary GLP and guideline-compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

CAPA 3050

IUPAC Name:

CAPA 3050

Constituent 2

Reference substance name:

ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

EC Number:

500-099-5

EC Name:

ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

Cas Number:

37625-56-2

Molecular formula:

(C6H14O3)x.C6H10O2 (x=0-6)

IUPAC Name:

2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol

Constituent 3

Reference substance name:

2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol

IUPAC Name:

2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): CAPA 3050
- Substance type: Oligomer
- Physical state: Liquid
- Analytical purity: 100%
- Lot/batch No.: WCB000999
- Expiration date of the lot/batch: 23th August 2015
- Stability under test conditions: Stable for the duration of the study
- Storage condition of test material: Ambient

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were male SPF-derived New Zealand White rabbits (2.5-3.0 kg), obtained from Harlan Olac, Zeist, The Netherlands. The animals were acclimatised for 11 days, and inspected be a veterinarian at the beginning of the the acclimatisation period. No abnormalties were detected.The rabbits were individually housed in stainless steel wire cages (KK 102). Bedding material was not provided. The rabbits received 80 g standard kaboratory diet (LKK-20, Hope Farms, The Netherlands), per day during the acclimatisation period. During the experiment the rabbits had free access to food and water. The animal room was maintained at a temperature of 19-20°C, relative humidity of 55-72%, artifical light was provided for 12 hours oer day, and radio-sound was provided for 24 hours per day. There were approximately 16 air changes per hour.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes after patch removal, then 24, 48 and 72 hours later.

Number of animals:

Three male rabbits.

Details on study design:

On the last day of acclimatisation, the backs of the rabbits were clipped free of hair. Three different test materials were tested on each rabbit at the same time (CAPA 205, CAPA 304, CAPA 305). Three separate 6 cm² patches were prepared per animal, 1 per substance. The patches, containing 0.5 g of test substance per patch, were held under occlusive Blenderm tape and secured in place on the back of the animal by adhesive tape. The animals were fitted with Elizabethan collars (IMS, Cheshire, UK) for the duration of the exposure period. After the 4 hour exposure period, the collars and patches were removed and the skin was wiped to remove and remaining test substance.Skin reactions were scored according to erythema and eschar formation (graded 0-4), and oedema formation (graded 0-4).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: All time points

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

other: No effects at any time point

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: all time points

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

other: No effects at any time point

Irritant / corrosive response data:

A single dermal exposure to CAPA 305 for 4 hours caused no erythema or oedema at any time point.

Other effects:

No other effects were reported.

Any other information on results incl. tables

No rabbit was given a score above zero at any of the time points up to 72 hours after patch removal, for either erythema or oedema formation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

CAPA 305 was considered to cause no skin irritation in rabbits. CAPA 305 was therefore classified as not irritating under CLP.

Executive summary:

The primary irritation potential of CAPA 305 was determined according to OECD method 404. A sample of 0.5 g of CAPA 305 was applied to the shaved intact back skin of 3 male New Zealand White rabbits, and held under an occlusive patch for 4 hours. Readings of the reactions for erythema and oedema were made at 30 minutes, and 24, 48 and 72 hours after patch removal. No signs of irritation were observed at any time point. CAPA 305 was therefore considered to cause no skin irritation in rabbits.