ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

Endpoint summary

Description of key information

CAPA 305 did not cause skin or eye irritation in modern guideline studies performed in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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.

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).

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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.

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.

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

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The primary irritation potential of CAPA 305 was determined in a GLP study according to OECD method 404 (Janssen, 1991). 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. No signs of irritation were observed in any of the rabbits tested. CAPA 305 was therefore considered to be non-irritating to skin.

Eye irritation

The primary eye irritation potential of CAPA 305 was tested in a GLP study 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. Slight lacrimation was observed in one rabbit at 1 hour after administration, this effect had disappeared at 24 hours. No other effects were observed. It was concluded that CAPA 305 is not irritating to eyes.

Justification for selection of skin irritation / corrosion endpoint:
Only study available

Justification for selection of eye irritation endpoint:
Only study available

Justification for classification or non-classification

CAPA 3050 was not found to be irritating to the skin or eye in guideline-compliant studies performed in the rabbit and therefore does not require classification according to the CLP Regulation.