reaction mass of sodium acetate, monoethylene glycol and diethylene glycol

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Well reported published study. Not a full repeat dose study end point set.

Data source

Reference

Reference Type:

publication

Title:

Prolonged lead exposure and fixed ratio performance

Author:

Cory-Slechta DA

Year:

1986

Bibliographic source:

Neurobehav Toxicol Teratol 8, 237-44

Materials and methods

Principles of method if other than guideline:

Study to evaluate the behaviour (neurotoxicity) of rats following sub-chronic to chronic exposure to lead. Lead dosed as acetate salt and sodium acetate used as control

Test material

Test material information

Constituent 1

Reference substance name:

Sodium acetate

EC Number:

204-823-8

EC Name:

Sodium acetate

Cas Number:

127-09-3

Molecular formula:

C2H4O2.Na

IUPAC Name:

sodium acetate

Test animals

Species:

rat

Strain:

Long-Evans

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms, Altamont, NY, USA
- Age at study initiation: 21 days
- Weight at study initiation: 32-44g
- Diet: American Institute of Nutrition semi-purified mouse rat diet (US Biochemical Corp Inc). Diet provided ad libitum until day 55 (start of behavioural studies) when diet was restricted to limit weight gain to 1-5g/day until weight reached 300g when diet was then ad libitum.

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Frequency of treatment:

ad libitum (drinking water)

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

50 ppm

Remarks:

nominal in drinking water

Doses / concentrations 2

Dose / conc.:

500 ppm

Remarks:

nominal in drinking water

Control animals:

no

Positive control:

lead acetate

Examinations

Observations and examinations performed and frequency:

BODY WEIGHT: Yes
- Time schedule for examinations: Weekly. Daily during behavioural testing.

NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: from age 55 days.
- Dose groups that were examined: all
- Functions tested: reinforcement behaviour . Animals trained to use lever press system with food as a reward. Animals ability to adapt and re-learn difference frequency response requirements of lever presses used as measure of neurobehaviour impairment.

Sacrifice and pathology:

None

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

no effects observed

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

Assuming a water consumption rate of 110ml/kg/day, 500ppm (assuming w/v) would equate to 55mg/kg/day.

Effect levels

Dose descriptor:

NOAEL

Effect level:

>= 500 ppm

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: No adverse effects seen.

Target system / organ toxicity

Critical effects observed:

no