Benzeneacetic acid, .alpha.,.alpha.-dimethyl-, ethyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Start of study: September 02 - End of study: September 19, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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

Remarks:

Principles of Good Laboratory Practice, annex of paragraph 19a, section 1 of the chemical law of July 25, 1994

Test material

Test material information

Constituent 1

Reference substance name:

α,α-Dimethyl-ethyl ester benzeneacetic acid

EC Number:

608-307-7

Cas Number:

2901-13-5

Molecular formula:

C12 H16 O2

IUPAC Name:

α,α-Dimethyl-ethyl ester benzeneacetic acid

Details on test material:

Name: Dimethylphenylessigsäureethylester
Synonyms: EDMPA
Chemical name: Benzeneacetic acid, α,α-dimethyl-, ethyl ester
Certificate of analysis: March 18, 1997
Purity: 99.8%
Appearance: clear, colorless liquid
Solubility: 0.3 g/L in water, miscible with alcohol, acetone and toluene
Batch number: B 0006
Date of production: March 12, 1997
Date of expiry: March 2000
Storage conditions: darkness at approximately 5°C in a refrigerator

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.7-3.9 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333) and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

0.1 ml/eye

Observation period (in vivo):

Eyes were examined 1, 24, 48 and 72 hours after administration of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes were washed out thoroughly with isotonie saline at approx. 37 °C.
- Time after start of exposure: 24h
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

20

Reversibility:

fully reversible within: 48h

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

80

Irritant / corrosive response data:

One hour up to one day after application, the conjunctivae of all animals showed definitely injected blood vessels up to a diffuse beefy red color. Onehour after application one animal showed a very slight swelling. Additionally, clear-colorless discharge were noted.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing of the substance for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.