2-methylbutyl acrylate

Toxicity to reproduction

Administrative data

Endpoint:

fertility, other

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read-across of data for an analogous chemical. The target chemical and the source chemical are very closely related alkyl acrylate compounds. They differ only by the addition of a methyl group in the butyl portion of the molecule. Both molecules are expected to be metabolized via the same hydrolysis and enzymatic pathways. The data from the source chemical are experimental results from well documented study report which meet basic scientific principles and are considered to be acceptable with restrictions.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Group of rats (20 male and 20 female per dose and control group) were exposed to butyl acrylate vapors (6 h/ day) over a period of 13 weeks at concentrations (analytically measured) of 21, 108, 211, and 546 ppm. Animals were observed for clinical signs, body weight gain, hematological and biochemical parameters. Necropsies were performed on all animals and weight of the testes were measured. Tissues, including seminal vesicles, prostate, epididymis/uterus, testes and ovary were examined histologically from all animals.

GLP compliance:

no

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

IUPAC Name:

butyl acrylate

Details on test material:

- Name of test material (as cited in study report): Butyl acrylate
- Analytical purity: 99.5 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

see 7.5.3.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure (if applicable):

whole body

Vehicle:

unchanged (no vehicle)

Details on exposure:

see 7.5.3.

Details on mating procedure:

not applicable

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

see 7.5.3.

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

6 h/day, 5 d/week for 13 weeks (63 exposures)

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 21, 108, 211, and 546 ppm (corresponding to 0, 0.11, 0.57, 1.11, 2.86 mg/L/day) Calculation of concentrations (mg/L) based on Derelanko MJ (2000). Toxicologist's Pocket Handbook, CRC Press, conversion table, p. 57.
Basis:
analytical conc.

No. of animals per sex per dose:

20

Control animals:

yes, sham-exposed

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEC

Effect level:

2.86 mg/L air (analytical)

Sex:

male/female

Basis for effect level:

other: no effects on reproductive organs

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

Data on reproductive organ toxicity were derived from a 3 month inhalation study. Respective results from animals exposed to the highest dose level of 546 ppm (2.86 mg/L) did not give evidence for any impairment of the investigated reproductive organs of both sexes.

Applicant's summary and conclusion

Executive summary:

The results presented in this summary are experimental results for the source chemical n-butyl acrylate. The results are considered to be appropriate for read-across to the target chemical 2-methylbutyl acrylate.