1-(4-trans-Propyl-[1,1-bicyclohexyl]-4-trans-yl)-4-trifluormethoxybenzene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 07, 1992 - June 12, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

OECD 1981, updated Guideline adopted Februaty 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene

EC Number:

603-929-5

Cas Number:

135734-59-7

Molecular formula:

C21H29F3O

IUPAC Name:

1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene

Test material form:

solid

Specific details on test material used for the study:

Batch: E919140

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 28 weeks
- Weight at study initiation:3.24 (3.13 - 3.43) kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 32°C
- Humidity (%): 39 - 61%

IN-LIFE DATES: From: day 1 To: day 8

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1g per animal

Observation period (in vivo):

24, 48, and 72 hours, then daily up to day 8 of the experimental part

Number of animals or in vitro replicates:

3 (1 male & 2 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according OECD-Guideline

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in all animals at 24 h which was fully reversibke wihtin 48 hours.

Other effects:

none

Any other information on results incl. tables

Study design

To test for primary eye irritation, the test material was instilled into the conjunctival say of rabbits. The first examination of the treated eye followed 1 hour after instillation. The examinations were performed daily for further 7 days.

Results

In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in all animals at 24 h which was fully reversible within 48 hours. The animal's individual mean scores (considering readings at 24 h, 28 h, and 72 h after installation of the test material) were below 1.0.

Conclusion

According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to these results, the test item is not considered to be classified as eye irritant as all animal's individual mean scores (considering readings at 24 h, 48 h and 72 h after installation of the test material) were below 1.0.

Executive summary:

The study was performed according to OECD 405 under GLP conditions. According to these results, for regulatory purposes there is no need for classification for eye irritation.