Reaction mass of (2R,7aR)-2,4,6,6-Tetramethyl-7,7a-dihydro-1,3-benzodioxol-5(6H)-one and (2S,7aS)-2,4,6,6-Tetramethyl-7,7a-dihydro-1,3-benzodioxol-5(6H)-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Reference 2

Reference Type:

other: Amendment to the report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

162691-58-9

EC Number:

605-300-0

Cas Number:

162691-58-9

IUPAC Name:

162691-58-9

Details on test material:

- Name of the test substance used in the study report: Asta-C9-Acetal
- Physical state/appearance : liquid, yellowish
- Storage conditions : refrigerator, exclusion of light

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler; Offenbach / Main, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: mean body weight: 3.18 kg
- Housing: Single housing stainless steel wire mesh cages with grating, floor area : 3000 cm2
- Diet: Kliba-labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland. About 130 g per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod: 12 h light and 12 h dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Substance was not washed out.

Observation period (in vivo):

15 d

Number of animals or in vitro replicates:

3

Details on study design:

- Readings: 1 h, 24 h, 48 h, 72 h, 8 d and 14 day after instillation
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, and #3

Time point:

other: mean 24-48-72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, and #3

Time point:

other: mean 24-48-72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean 24-48-72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean 24-48-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean 24-48-72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean 24-48-72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean 24-48-72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 15 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean 24-48-72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

One female animal showed a contracted pupil at 1 hour after exposure

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Under the concitions of the performed eye irritation study, the test substance was determined to be not irritating to the eye.

Executive summary:

The potential to cause damage to the conjunctiva, iris or cornea was assessed in an OECD 405 guideline study in compliance with GLP. Three white Vienna rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0 (all animals) for corneal opacity and iritis, 0, 1, and 0.3 for chemosis and 0.3, 2, and 1 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed were reversible in one animal within 48 hours; another animal was free of signs 72 hours after instillation and in the 3rd animal the eye findings were reversible within 15 days after instillation. Based on these findings it is concluded that the test substance is not irritating to the eye