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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 November 2001- 21 November 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

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

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 males and 5 females were used as test animals.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Duration of exposure:

15 days

Doses:

Single dose on day 1 of 2000mg/kg

No. of animals per sex per dose:

5 males and 5 females were used as test animals.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male was found dead on day 1. No further mortality occured.

Clinical signs:

Hunched posture was noted among two makes and one femaleon days 2 and/or 3.
Maculate or general erythema was seen on the treated skin area of four females during the observation period.
No clinical signs were shown by the animal that died on day 1. The surviving animals had recovered from the symptoms between days 4 and 12.

Body weight:

The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.

Gross pathology:

No toxicologically significant abnormalities were found at macroscopic post mortem examinationof the animals. Pelvic dilation of the kidneys was noted in one male and one female. This finding is considered to be within the background pathology encountered for rats of this age and strain.
No macroscopic abnormalities were noted among the other animals, including the animal that died on day 1.

Applicant's summary and conclusion

Interpretation of results:

not classified

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 dermal toxicity. LD50 > 2000mg/kg bw

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 dermal toxicity. LD50 > 2000mg/kg bw