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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable with restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986

Materials and methods

Principles of method if other than guideline:
Five-week-old rats (10/sex/group) received oral doses of ethyl acrylate in corn oil 5 days per week for 13 weeks. Animals were assigned to control or treatment groups according to a random number table. Animals were observed twice daily for clinical signs and weighed weekly. Necropsies were performed on all animals. Tissues, including the prostate/testes (males) and ovaries/uterus (females) were examined histologically from all control and high dose animals.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl acrylate
EC Number:
205-438-8
EC Name:
Ethyl acrylate
Cas Number:
140-88-5
Molecular formula:
C5H8O2
IUPAC Name:
ethyl acrylate
Details on test material:
- Name of test material (as cited in study report): Ethyl acrylate
- Analytical purity: 99 % and 99.5 % for lot. No. 37201 and 343029, respectively.
- Lot/batch No.: 37201 and 343029
- Stability under test conditions: Contained 15 ppm of the monoethyl ether of hydroquinone as an inhibitor.
- Storage condition of test material: stored at -20°C during the studies

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
see 7.5.1
Details on mating procedure:
not applicable
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
see 7.5.1
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
5 days/week for 13 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
7, 14, 28, 55, or 110 mg/kg bw (0.7, 0.14, 0.28, 0.55, and 1.1 % solution in corn oil; 10 mL/kg bw)
Basis:
actual ingested
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
110 mg/kg bw/day (actual dose received)
Sex:
male/female
Basis for effect level:
other: no effects on reproductive organs

Results: F1 generation

Effect levels (F1)

Remarks on result:
not measured/tested

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Data on reproductive organ toxicity (testes weights as well as information on gross and microscopic pathology for testes, prostate, ovaries, and uteri) were derived from a 3 month study by the oral route ( EA, 5 days/week by gavage, 10 animals/sex/dose level) with Fischer rats according to the NTP protocol which is similar to OECD guideline 408. No effects were observed at the highest dose tested (110 mg/kg bw/day).

Applicant's summary and conclusion