Reaction mass of 2-methylpropan-2-ol and acetone and water

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, OECD Guideline compliant in vitro study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The purpose of this study was to determine the eye irritation potential of the test material using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Details on test material:

Batch No. S-122009-311853
Purity: 100%

Test animals / tissue source

Species:

human

Strain:

other: not applicable

Details on test animals or tissues and environmental conditions:

Not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

30 microliters

Duration of treatment / exposure:

10 minutes

Observation period (in vivo):

10 minutes

Number of animals or in vitro replicates:

Not applicable

Details on study design:

The experimental design of the study consists of a test for direct reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) by the test material followed by the main test.

For the main test, triplicate SkinEthic tissues were treated with 30 IJI of the test material for 10 minutes. Triplicate tissues treated with 30 IJI of Solution A served as the negative control and triplicate tissues treated with 30 IJI of 1% w/v Sodium Dodecyl Sulphate served as the positive control.

At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues.

After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured. The optical density was measured at 540 nm (00540). Data are presented in the form of percentage viability (MTT conversion relative to negative controls).

The test material was classified according to the following criteria:

i) If the percentage relative mean tissue viability was > or = 60% the test material
was considered to be non-irritant.

ii) If the percentage relative mean tissue viability was <60% the test material
was considered to be an irritant.

Results and discussion

In vivo

Results

Irritation parameter:

other: In vitro tissue viability

Basis:

mean

Time point:

other: 10 minutes

Score:

7.5

Max. score:

5.8

Reversibility:

other: not applicable

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Fuel - A is considered to be irritating to the eye, based on the reduction in eye corneal tissue viability after 10 minutes exposure in vitro.