Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report for SIAM 15 (n-Butyl acrylate)

Author:

OECD

Year:

2002

Bibliographic source:

UNEP Publications

Reference 2

Reference Type:

other: method description

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Principles of method if other than guideline:

Pregnant mice received the test compound via oral gavage on days 5 - 20 of gestation. The controls received concurrently the vehicle. Doses of n-butyl acrylate were 100, 1000, 1500, 2000, 2500, 3000, 4000 mg/kg bw/day.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyl acrylate

EC Number:

205-480-7

EC Name:

Butyl acrylate

Cas Number:

141-32-2

Molecular formula:

C7H12O2

IUPAC Name:

butyl acrylate

Test animals

Species:

mouse

Strain:

CD-1

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on mating procedure:

- Impregnation procedure: cohoused

Duration of treatment / exposure:

day 6 - 15 of gestation

Frequency of treatment:

dayly

No. of animals per sex per dose:

25-30

Control animals:

yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

2 000 mg/kg bw/day

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

When adminitered orally in mice at day 6 - 15 of gestation, butyl acrylate showed effects on offspring at doses highly above the threshold for maternal toxicity. The NOAEL for developmental toxicity is 1000 mg/kg based on diminished fetal body weights at 1500 mg/kg and above. The NOAEL for teratogenicity is 2000 mg/kg based on malformations observed at higher doses.

Executive summary:

Mice obained n-butyl acrylate during day 6 -15 of gestation by oral gavage in doses of 0, 100, 1000, 1500, 2000, 3000 and 4000 mg/kg. The highest dose was lethal to all animals. At 3000 and 2500 mg/kg, 2 of 30 animals died. At 2000, 1500 and 1000 mg/kg, 1 of 30 animals died. Maternal body weight gain and fetal body weights were significantly reduced at 1500 mg/kg and higher dose groups. The percentage of resorptions was significantly increased at 2500 and 3000 mg/kg.Up to 2000 mg/kg and in the controls, sporadic malformations on different sides were observed (i.e. single cases of cleft palate, fused ribs, sternebrae, and arches, extra arches, branced ribs). There was no dose dependency with the exception of a slight increase when taking the sum of all events per dose group together. In the higher dose groups 2500 and 3000 mg/kg, a significant increase of fetuses with external and skeletal malfunctions and variations (cleft palate, exencephaly, open eyes, fused arches, fused ribs).

NOAEL (maternal): 100 mg/kg

NOAEL (developmental toxicity): 1000 mg/kg

NOAEL (teratogenicity): 2000 mg/kg