Reaction mass of bis(2-methylpropyl) (1R,2R,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate and bis(2-methylpropyl) (1S,2S,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 March 2012 - 22 May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,2-bis(2-methylpropyl) (1R,2R,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate; 1,2-bis(2-methylpropyl) (1S,2S,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate

EC Number:

943-279-2

Molecular formula:

C18H32O4

IUPAC Name:

1,2-bis(2-methylpropyl) (1R,2R,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate; 1,2-bis(2-methylpropyl) (1S,2S,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate

Test material form:

liquid

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Characteristics of donor animals: Eyes were excised from animals aged approximately 24 months
- Storage, temperature and transport conditions of ocular tissue: Eyes were transported and maintained at ambient temperature in sufficient HBSS containing 1% (v/v) penicillin / streptomycin solution to fully cover the eyes in
- Time interval prior to initiating testing: The eyes were used within 4 hours of excision
- indication of any existing defects or lesions in ocular tissue samples: Eyes were examined for defects (opacity, scratches, cuts, pigmentation, etc.) prior to use and those exhibiting defects were discarded
- Indication of any antibiotics used: Excised eyes were maintaned and transported in HBSS containing 1% (v/v) penicillin / streptomycin solution

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 750 µL
- Concentration: Undiluted

Duration of treatment / exposure:

10 minutes ± 30 seconds

Duration of post- treatment incubation (in vitro):

Two hours ± 10 minutes

Number of animals or in vitro replicates:

Three / triplicate

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least three times or until the wash medium was clear with no discolouration (four times in the case of SIBE138)

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Value:

0.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Value:

0.333

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The test substance, SIBE 138, was diluted to 10% w/v with 0.9% saline to obtain an aqueous solution for pH measurement. The pH of the test substance, measured using pH indicator paper, was approximately 7.0.

Sample Opacity ± SD = 0.333 ± 0.000

Permeability ± SD = 0.013 ± 0.008

In vitro irritancy Score ± SD = 0.5 ± 0.1

In vitro classification = Non-Corrosive/Non-Severe irritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance, SIBE 138, elicited an In Vitro Irritancy Score of 0.5 ± 0.1 and was predicted to be a non-corrosive / non-severe eye irritant.