Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No guideline or GLP followed and the information given is very limited..

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tetramethylammonium chloride
- Source: Matheson, Coleman & Bell, Cincinnati, Ohio, USA

Test animals

Species:
other: chicken
Strain:
other: White Leghorn
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kimber Farms Inc., Niles, California, USA
- Age at study initiation: egg stage

ENVIRONMENTAL CONDITIONS
- Eggs were incubated in a Jamesway model 252B automatic egg incubator (James Manufacturing Co., Fort Atkinson, Wisconsin, USA)
- Temperature (°C):37.5
- Humidity (%): 73

Administration / exposure

Route of administration:
other: injection into yolk
Vehicle:
water
Details on exposure:
Volume = 0.1 ml
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
Embryos were collected from eggs on day 6
Frequency of treatment:
Single injection, on day 2 (2 eggs) or 4 (2 eggs)
Duration of test:
6 days
Doses / concentrations
Remarks:
Doses / Concentrations:
10 mg/egg
Basis:
nominal conc.
No. of animals per sex per dose:
4
Control animals:
other: unexposed eggs... (see attached file)
Details on study design:
This study was aimed at comparing the teratogenicity of insecticides with known neuro-toxicity with compounds that are known to be both neurotoxic and teratogenic, such as tetramethylammonium chloride.
The teratogenic effects of the compounds were investigated, furthermore the distribution of injected acetyl-1-14C-choline and its hydrolysis products.

Results and discussion

Effect levels

Dose descriptor:
dose level:
Effect level:
10 other: mg/egg
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Severe manifestation of teratogenic signs.

Observed effects

Tetramethylammonium chloride caused severe teratogenic effects (+++; max of positive control = ++++), greatly reducing body length. No significant differences between untreated and TMAC-treated chick embryo's were observed in distribution of acetyl-14C-choline (and its metabolites) that was injected one day before collection of the embryo's.
No differences were observed between the eggs exposed on day 2 or day 4.

Applicant's summary and conclusion

Conclusions:
Fertile eggs were injected with 10 mg/egg of the test substance. After 2 or 4 days, the embryo's were shown to have greatly reduced body length.
Based on these data, it can be concluded that at the dose level of 10 mg/egg tetramethylammonium chloride is teratogenic to chicken embryos.
Executive summary:

Fertile eggs were injected with 10 mg/egg of the test substance. Upon recovery of the embryo's at 2 or 4 days after injection of the test substance, the embryo's showed to have greatly reduced body length. No significant differences between the TMAC and untreated eggs were observed in distribution of acetyl-14C-choline, that was injected one day before embryo's were collected. No differences were observed between the eggs exposed on day 2 or day 4.

Based on these data, it can be concluded that at the dose level of 10 mg/egg tetramethylammonium chloride is teratogenic to chicken embryo's.