tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 December 2001- 20 December 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate

EC Number:

603-330-9

Cas Number:

129332-29-2

Molecular formula:

C28H34FNO4

IUPAC Name:

tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after instillation.

Number of animals or in vitro replicates:

3 animals of one sex

Results and discussion

In vivo

Irritant / corrosive response data:

Irritation: Instillation of approximately 29mg of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48hours in all animals.

Corrosion: There was no evidence of ocular corrision.

Colouration: No staining of ocular tissues by the test substance was observed. Remnants of the test substance were present in the eyes of all animals on day 1. Green staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.

Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Instillation of approximately 29mg of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48hours in all animals

Remnants of the test substance were present in the eyes of all animals on day 1. Green staining of the fur on the heads and paws, caused by the test substance, was noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation. Non irritant.

Executive summary:

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation. Non irritant.