Benzeneacetic acid, 4-(cyclopropylcarbonyl)-.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:

August 30 to september 25, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to international guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid

EC Number:

605-546-9

Cas Number:

169280-10-8

Molecular formula:

C16 H20 O3

IUPAC Name:

4-(Cyclopropylcarbonyl)-α,α-dimethyl-ethyl ester benzeneacetic acid

Details on test material:

Batch: W0147
Sample: 181669 1 001
Physical state: powder
Date of arrival: August 23, 2001
Storage: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino (strain not defined)

Details on test animals or tissues and environmental conditions:

Breeding: Dr.Zimmermann Schweizer Hof, D-73453 Untergröningen/Aalen, Germany
Diet: Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P, Raiffesen Kraftfutterwerk Kehl, ad libitum
Water: Community tap water from Karlsruhe: free access for the animals by daily changing of the watering-bottles.
Husbandry: Rabbits housed individually in wire grating cages (2450 cm², height 42 cm) without bedding.
Temperature: 20-23 °C
Relative humidity: 30-70%
Light-dark rythm: 12 : 12
Animals were acclimated to the test conditions for 5 days prior to the administration.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Left eye of each treated rabbit was used for control.

Amount / concentration applied:

0.1 g into the conjonctival sac of the right eye to each rabbits.

Duration of treatment / exposure:

24 h

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

3

Details on study design:

The substance was applied to the right eye, while the left eye was considered as control. Both eyes were anaesthesized. The lids of the right eye were gently hold together for one second to prevent loss of substance. After 24 hours the eyes were gently washed with NaCl 0.9%,

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 6 days following exposure

Score:

0

Max. score:

3

Remarks on result:

other: A score of 0 was recorded for all three rabbits throughout the 6-day period of observation.

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 6 days following exposure

Score:

0

Max. score:

4

Remarks on result:

other: A score of 0 was recorded for all three rabbits throughout the 6-day period of observation.

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 6 days following exposure

Score:

0

Max. score:

2

Remarks on result:

other: A score of 0 was recorded for all three rabbits throughout the 6-day period of observation.

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 6 days following exposure

Score:

0

Max. score:

4

Remarks on result:

other: A score of 0 was recorded for all three rabbits throughout the 6-day period of observation.

Other effects:

No other effects.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test experimental conditions, the substance is considered to be not irritant for eyes in rabbits.