Butanoic acid, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl ester

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability 2 is assigned because of the information is used from an analogue.

Justification for type of information:

The screening for reproductive / developmental toxicity of Cyclobutanate is based on read-across with substance Cyclacet. The read across justification is presented in the Endpoint summary and the accompanying files are attached there.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG 421

GLP compliance:

yes

Limit test:

no

Test material

Test material information

1

Reference substance name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate

EC Number:

911-369-0

Molecular formula:

C12H16O2

IUPAC Name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

See 7.8.1: Harlan study

Administration / exposure

Route of administration:

oral: gavage

Details on exposure:

See 7.8.1: Harlan study

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

See 7.8.1: Harlan study

Details on mating procedure:

See 7.8.1: Harlan study

Duration of treatment / exposure:

See 7.8.1: Harlan study

Frequency of treatment:

See 7.8.1: Harlan study

Duration of test:

See 7.8.1: Harlan study

No. of animals per sex per dose:

See 7.8.1: Harlan study

Details on study design:

See 7.8.1: Harlan study

Examinations

Maternal examinations:

See 7.8.1: Harlan study

Ovaries and uterine content:

See 7.8.1: Harlan study

Fetal examinations:

See 7.8.1: Harlan study

Statistics:

See 7.8.1: Harlan study

Indices:

See 7.8.1: Harlan study

Historical control data:

See 7.8.1: Harlan study

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

>= 1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOAEL

Effect level:

>= 1 000 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Remarks on result:

not measured/tested

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test (OECD 421, GLP, oral gavage), the systemic NOAEL was determined to be 1000 mg/kg bw/day based on the absence of treatment-related toxicologically relevant effects. The developmental NOAEL is considered to be >= 1000 mg/kg bw/day based on the absence of treatment-related debelopmental effects

Executive summary:

See executive summary at 7.8.1, the Harlan study