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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Principles of method if other than guideline:
Study well documented, meets generally accepted scientific principles, acceptable for assessment
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetraethyllead
EC Number:
201-075-4
EC Name:
Tetraethyllead
Cas Number:
78-00-2
Molecular formula:
C8H20Pb
IUPAC Name:
tetraethylplumbane

Test animals

Species:
monkey
Strain:
other: Rhesus
Sex:
male/female
Details on test animals or test system and environmental conditions:
3 groups of 2 male and 2 female

Administration / exposure

Route of administration:
intravenous
Vehicle:
ethanol
Details on exposure:
0.6 - 1.2 mg/ kg/ day
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Low dose: 14 days. High dose: 7 days.
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
Low dose: 0.6 mg/kg/bw/day for 7 days, then 1.2mg/kg/bw/day for 7 days. High dose: 6.0mg/kg/bw/day for 7 days.
No. of animals per sex per dose:
2
Control animals:
yes
Details on study design:
Post-exposure period: 28 days

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
In the high dose group, three out of four animals died.
Mortality:
mortality observed, treatment-related
Description (incidence):
In the high dose group, three out of four animals died.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Symptoms in high dose animals included reduced  body weight
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Symptoms in high dose animals included reduced food intake
Food efficiency:
effects observed, treatment-related
Description (incidence and severity):
Symptoms in high dose animals included
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
In the high dose group included lowered brain cholesterinase and increased serum urea, serum bilrubin and glycosuria. No clinico-chemical findings were observed in the low dose group.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
In the high dose group, pathological findings included degeneration of the peripheral neuraxons and muscle fibre
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
For the low dose group
Histopathological findings: neoplastic:
no effects observed
Description (incidence and severity):
For the low dose group

Effect levels

Dose descriptor:
NOAEL
Effect level:
0.6 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

In low dose animals no abnormal symptoms were detected.   
Symptoms in high dose animals included gastro-intestinal disturbances, pathological reflexes, muscle tremor, and 
reduced food intake and body weight.

Applicant's summary and conclusion