Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 April 2002 - 12 April 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

In vivo information of 2002 is used for the assessment of the eye irritation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

January 1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

EC Number:

228-536-2

EC Name:

Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Cas Number:

6290-17-1

Molecular formula:

C9H16O4

IUPAC Name:

ethyl 2-(2,4-dimethyl-1,3-dioxolan-2-yl)acetate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: albino female rabbits of the stock Chbb:GM(SPF) - Littlerussian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: no

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature: 20°C ± 3°C
- Humidity: 55 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not indicated

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal three more rabbits were included in the study.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
After rinsing with 20 ml 0.9 % sodium chloride solution the eyes were examined again using UVlight to detect possible corneal damage.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal:

Remarks:

#1, #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 7

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

- One hour after the application of the test article all animals showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal were observed in one animal.
- 24 hours after the application of the test article two animals showed some conjunctival vessels definitely injected and a swelling above normal. Some conjunctival vessels definitely injected were observed in the third animal, whereas the fourth animal did not show any signs of eye irritation.
- 48 and 72 hours after the application of the test article all animals were free of any signs of eye irritation.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant.

Remarks:

In accordance Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

Based on the results of an eye irritation study, performed according to OECD 405 guideline and under GLP, the substance is considered not to be an eye irritant.

Executive summary:

A study, performed according to OECD 405 guideline and under GLP, was conducted to assess the potential for the substance to be eye irritating. Four albino rabbits were used: one rabbit initially was exposed to the substance and, since no marked eye irritation was seen in this animal, three more rabbits were included in the study. An amount of 0.1 mL of the substance was applied directly to one eye and the other, untreated, eye was used as control. Observations were made 1 hours, 24 hours, 48 hours and 72 hours after dosing. The effects were scored according to Draize. No effects were observed on the cornea and the iris. Effects on the conjunctivae were observed in all animals from 1 hour after treatment, these effects were fully reversed within 48 hours. Based on the results, the substance is considered not to be an eye irritant and does not need to be classified according to Regulation (EC) No. 1272/2008 and its amendments.