Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4th November to 2nd December 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Proprietary study conducted according to guidelines and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
e-Caprolactone, a viscous liquid, supplied by Solvay S.A. Brussels. Batch No: WA2809/0791. Purity: >99%. Prior to dosing, the material was stored in a refrigerator.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
SPF-derived male New Zealad White rabbits (one animal weighed 1.8-2.2kg, three weighed 2.5-3.0kg), obtained from Harlan Olac. Animals underwent an 11 day acclimatisation period. Rabbits were housed individually in stainless steel wire cages without sawdust or woodchips (i.e. no extraneous material that might produce eye irritation). They received 80g food per day (standard laboratory diet), with free access to the food and water. Temperature of the animal room was maintained at 19-22oC, relative humidity 52-72%, artificial light from 7am till 7pm, radio-sound from 7am till 7pm, and approximately 16 air changes per hour.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1ml e-Caprolactone applied to conjunctival sac.
Duration of treatment / exposure:
Substance was applied to conjunctival sac, and eyelid held closed for approximately 1 second.
Observation period (in vivo):
Observations were made at 1, 24, 48, 72 hours and 7 days after treatment.
Number of animals or in vitro replicates:
Initially 4 animals were used, one of these animals was injured and euthanased 1 hour post-treatment. A replacement rabbit was obtained from the supplier.
Details on study design:
Four rabbits were used. 0.1ml test substance was dropped into the conjuctival sac of the left eye. Eye reactions were scored at 1, 24, 48, 72 hours and 7 days after treatment. The scoring system used was that according to Draize (1944), and the results were interpreted according to the Commission Directive 91/325/EEC. The right eye remained untreated to serve as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 24-72h
Score:
1.78
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.89
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
1.44
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.89
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
At 1 hour very slight opacity, iritis, redness and very slight chemosis were observed in three rabbits, and slight iritis, redness and chemosis was observed in the fourth. Severe discharge was observed in animal's 1-3 and moderate discharge in animal 4. The following observations are limited to 3 animals: at 24 hours slight opacity and iritis were observed, slight to moderate redness was observed. Very slight to sight chemosis was observed. At 48 hours opacity was very slight to slight. Redness was slight to moderate. Chemosis was very slight. At 72 hours very slight to slight opacity and slight iritis were observed. Slight to moderate redness were observed. All symptoms had disappeared by day 7.
Other effects:
No additional effects.

Any other information on results incl. tables

Scores for ocular effects

Observation

1h

24h

48h

72h

Mean (24-72h)

7d

Cornea

Opacity

1,1,0

2,2,2

2,2,1

2,2,1

1.78

0,0,0

Iris

Lesion

1,1,1

1,1,1

1,1,1

1,1,0

0.89

0,0,0

Conjunctivae

Erythema

1,1,1

2,2,1

1,2,1

1,2,1

1.44

0,0,0

Chemosis

1,1,2

2,1,1

1,1,1

0,1,0

0.89

0,0,0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to labelling regulations e-Caprolactone is classified as irritating to the eye.
Executive summary:

The primary irritation of e-Caprolactone to the eye of male rabbits was determined in this guideline study. 0.1ml substance was introduced to the conjunctival sac of the left eye of three rabbits (the right eye remained untreated to serve as a control). The eyes of the rabbits were examined and the ocular reactions graded at intervals up to and including 7 days after treatment. Various signs of irritation were observed (corneal opacity, iris lesion, conjunctival erythema, chemosis and discharge), lthough all symptoms were reversible by Day 7. The substance requires classification as an eye irritant according to Regulation (EC) No 1272/2008 (CLP) and according to Directive 67/548/EEC. It is classified as an eye irritant and assigned the symbol Xi and the risk-phrase R36 "Irritating to eyes". It is an eye irritant category 2 and is assigned the pictogram GHS07 with the signal word "warning" and the hazard statement H319 "causes serious eye irritation".