ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 to 28 November 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The animals were male SPF-derived New Zealand White rabbits (1.8-2.2 kg), obtained from Harlan Olac, The Netherlands. They were acclimatised for 11 days, and at the beginning of the acclimatisation period they were inspected for signs of illness. No abnormalities were detected.The rabbits were housed individually in stainless steel wire cages (KK 102). Bedding material was not provided. The rabbits received 80 g standard laboratory 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, a relative humidity of 52-72%, artificial light was provided for 12 hours per day, and radio sound was provided for 12 hours per day. There were approximately 16 air changes per hour.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The eyelids were held gently closed for a short period after administration of the test substance. The test substance was not washed from the eyes.

Observation period (in vivo):

Reactions were scored at 1, 24, 48 and 72 hours after application.

Number of animals or in vitro replicates:

Three male rabbits.

Details on study design:

After the acclimatisation period, both eyes of each rabbit were examined with the aid of a slit-lamp. Only those rabits without eye defects or signs of irritation were used. 0.1 mL CAPA 305 was placed in the conjunctival sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed. The lids were then gently held together for a short period and the rabbit was released. The other eye, remaining untreated, served as a control.Scoring of ocular reactions was performed according to the Draize et al (1944) scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: All time points

Score:

0

Max. score:

4

Reversibility:

other:

Remarks on result:

other: No effects at any time point

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: All time points

Score:

0

Max. score:

2

Reversibility:

other: no effects were observed

Remarks on result:

other: No effects at any time point

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: All time points

Score:

0

Max. score:

3

Reversibility:

other: no effects were observed

Remarks on result:

other: No effects at any time point

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: all time points

Score:

0

Max. score:

4

Reversibility:

other: no effects were observed

Remarks on result:

other: No effects at any time point

Irritant / corrosive response data:

Slight lacrimation was observed in rabbit no. 1 at 1 hour after administration. The effect had disappeared at 24 hours.

Other effects:

No other effects were reported.

Any other information on results incl. tables

With the exception of rabbit no. 1 showing slight lacrimation at 1 hour post-administration (Score 1), all rabbits were given scores of zero at all time points.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

No evidence of eye irritation was seen under the conditions of this study.

Executive summary:

The primary eye irritation potential of CAPA 305 was tested according to OECD method 405. A sample of 0.1 ml CAPA 305 was placed into the conjunctival sac of one eye of each of 3 male New Zealand White rabbits. The eyes of the rabbits were examined and the ocular reactions graded (according to Draize et al, 1944) at 1, 24, 48 and 72 hours after administration. Slight lacrimation was observed in one rabbit at 1 hour after administration, this effect had disappeared at 24 hours. No other effects were observed. CAPA 305 caused no significant eye irritation in the three rabbits.