Ethyl formate

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Toxicity and Teratogenicity of Food Additive Chemicals in the Developing Chicken Embryo

Author:

M. JACQUELINE VERRETT et al

Year:

1980

Bibliographic source:

TOXICOLOGY AND APPLIED PHARMACOLOGY (1980)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Teratogenicity of test Chemicals was performed in the Developing Chicken Embryo

GLP compliance:

not specified

Type of method:

in vitro

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl formate

EC Number:

203-721-0

EC Name:

Ethyl formate

Cas Number:

109-94-4

Molecular formula:

C3H6O2

IUPAC Name:

ethyl formate

Details on test material:

- Name of test material: Ethyl formate
- Molecular formula: C3H6O2
- Molecular weight: 74.0784 g/mol
- Smiles notation: O(CC)C=O
- InChI: 1S/C3H6O2/c1-2-5-3-4/h3H,2H2,1H34H3;1H
- Substance type: organic
- Physical state: liquid

Test animals

Species:

other: Chicken

Strain:

other: Single-Comb White Leghorn

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data avilable

Administration / exposure

Route of administration:

other: Injection (Via Yolk and via air cell injection)

Vehicle:

not specified

Details on exposure:

No data avilable

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

At two stages of incubation: preincubation (0 hr) and at the fourth day (96 hr)

Frequency of treatment:

At 0h and 96 h

Duration of test:

96 h

Doses / concentrations

Remarks:

0.50 to 75 mg/egg (5 dose level)

No. of animals per sex per dose:

500 eggs (100 eggs per dose)

Control animals:

yes

Statistics:

No data avilable

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

25 other: mg/egg

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: No teratogenic effect were observed

Remarks on result:

other: No teratogenic effect were observed

Observed effects

Mortality, abnormalities included all structural anomalies as well as toxic responses such as edema, hemorrhage, hypopigmentation of the down, significant growth retardation, cachexia, and other nerve disorders. Structural abnormality of the head, viscera, limbs, or body skeleton were examined.No teratogenic effect were observed

Applicant's summary and conclusion

Conclusions:

The NOAEL value for teretogenicity of test chemical was considered to be 25 mg/egg in chicken embryo.

Executive summary:

Teretogenicity study of test chemical was conducted in Fresh fertile eggs from Single-Comb White LeghornChicken.Test chemical was administered by two routes, into tha yolk and through the air cell. For each enjection route, eggs were treated at0h and at 96 h. Five dose level tested range from 0.50 to 75 mg/egg and 100 embryos were treated per dose. Mortality, abnormalities included

all structural anomalies as well as toxic responses such as edema, hemorrhage, hypopigmentation of the down, significant growth retardation, cachexia, and other nerve disorders.Structural abnormality of the head, viscera, limbs, or body skeleton were examined. No teretogenic effect observed at dose level of 25 mg/egg. Hence,the NOAEL value for teretogenicity of test chemical was considered to be 25 mg/egg in chicken embryo.