Cyclododecanone, reaction products with cyclized 3-chloro-2-methyl-1-propene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study according to current guidelines but reported as summary report, non GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2014

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)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro- 1H-cyclopentacyclododecen

IUPAC Name:

2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro- 1H-cyclopentacyclododecen

Details on test material:

- Name of test material (as cited in study report): 2-Methyl-4,5,6,7,8,9,10,11,12,13-decahydro-1 H-cyclopentacyclododecen
- Physical state: Liquid/ brown, turbid
- Analytical purity: 62.5 area-% (not corrected for the water content.)
- Lot/batch No.: Methyl-Cyclopentadien-Cyclododecan (Austrag Gasphase SVA-Fabrik 02-18.10.2012)
- Storage condition of test material: Room temperature
- pH value: approx. 5

Test animals / tissue source

Species:

other: not applicable

Strain:

other: not applicable

Details on test animals or tissues and environmental conditions:

not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

750 μL of the undiluted test substance

Duration of treatment / exposure:

10 minutes followed by a 2-hours post-incubation period

Observation period (in vivo):

10 minutes followed by a 2-hours post-incubation period

Number of animals or in vitro replicates:

not applicable

Details on study design:

The test method consists of a topical exposure of the test substance to the epithelial surface of isolated corneas from the eyes of freshly slaughtered cattle. Corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements are used to calculate an In Vitro lrritancy Score (IVIS) of the test substance, which is used for the prediction of serious eye damage.
Histological evaluation of the treated corneas was performed in addition to the assessment of opacity and permeability.
Three corneas were treated with 750 μL of the undiluted test substance for 10 minutes followed by a 2-hours post-incubation period.

Negative control: de-ionized water
Positive control: 100% dimethylformamide

Results and discussion

In vivo

Results

Irritation parameter:

other: IVIS

Basis:

mean

Time point:

other: 10 minutes followed by a 2-hours post-incubation period

Score:

0.3

Reversibility:

other: not applicable

Any other information on results incl. tables

The mean IVIS of the negative and positive controls was 1.6 and 121, respectively.

Histopathological evaluation resulted in no findings for test substance and negative control and severe findings (IV) for the positive control.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive or severely irritating.

Conclusions:

The present data on eye irritation do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.