Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
5 to 9 July 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Proprietary GLP guideline-compliant study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TMPDE. The trade name of the substance was NEOALLYL T-20, lot no. 30341, received on 7 June 1993. The substance was a mixture of Trimethylolpropane Diallyl Ether (87.4%), Trimethylolpropane Monoallyl Ether (6.9%), and Trimethylolpropane Triallyl Ether (5.7%). The purity was given as 100%. The substance was described as a colourless liquid, and was stored in a metal canister at 4°C in the dark.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were three New Zealand White rabbits supplied by David Percival Ltd., Cheshire, UK. The animals weighed 2.02 to 2.28 kg and were 12-16 weeks old at the start of the study, they were acclimatised for a minimum of 5 days. Individuals were identified by unique numbers written on the inner surface of the ear with an indelible black marker.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml was instilled into the right eye
Duration of treatment / exposure:
Single administration
Observation period (in vivo):
72 hours following treatment
Number of animals or in vitro replicates:
3 females
Details on study design:
Immediately before the start of the test, both eyer of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.
One rabbit was initially treated , 0.1 ml test substance was instilled into the conjunctival sac of the right eye. The upper and lower lids were held together for about 1 second immediately after instillation, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on instillation, one drop of local anaesthetic ("Ophthine") was instilled into both eyes of these animals 1-2 minutes before treatment.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation from Draize (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics".Examination of the eye was facilitated by the use of light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Residual test material was noted around the treated eye of all animals one hour after treatment.
Diffuse corneal opacity was noted in two treated eyes at the 24 and 48 hour observations. No other corneal effects were noted. Iridial effects were noted. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment with minimal to moderate conjunctival irritation at the 24 hour observation. Minimal conjunctival redness was noted in two treated eyes at the 48 hour observation.
Other effects:
No other effects reported.

Any other information on results incl. tables

Table 1. Individual ocular irritation scores

Rabbit Number & Sex (Bodyweight Kg)

Time After Treatment

Corneal Opacity

Iridial Inflammation

Conjunctival Redness

Conjuncitval Chemosis

95 Female (2.20)

24 hours

0

0

1

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Total

0

0

1

0

Mean

0.0

0.0

0.3

0.0

 

96 Female (2.53)

24 hours

1

1

2

1

48 hours

1

0

1

0

72 hours

0

0

0

0

Total

2

1

3

1

Mean

0.7

0.3

1.0

0.3

 

99 Female (2.20)

24 hours

1

1

2

2

48 hours

1

0

1

0

72 hours

0

0

0

0

Total

2

1

3

2

Mean

0.7

0.3

1.0

0.7

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found to be a mild eye irritant under the conditions of this study, the severity of the effects does not trigger classification of the substance as an eye irritant under CLP Regulation (EC) No 1272/2008.
Executive summary:

The eye irritant potential of TMPDE (NEOALLYL T-20) was assessed in three New Zealand White rabbits according to OECD method 405. A single instillation of the test material to the non-irrigated eye produced diffuse corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation. Treated eyes appeared normal 72 hours after treatment and the severity of the effects does not trigger classification of the substance as an eye irritant under CLP Regulation (EC) No 1272/2008.