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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.44
Max. score:
20
Reversibility:
fully reversible within: 48h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
10
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72h
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.

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