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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Toxicological assessment of alkyllead and inorganic lead: a multidisciplinary approach
Author:
Franklin, C.A., Yagminas, A.P., Golman, A.P., Villineuve, D.C., Little, P.B., Valli, V.E.O.
Year:
1987
Bibliographic source:
Trace Subst. Environ. Health Vol 21, pp 286-296

Materials and methods

Principles of method if other than guideline:
No data on the exact method used is available
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:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Animals kept in cages. Test conditions: 22 degrees C, 50% relative humidity, 12 hours light, food and water ad libitum
5 Animals per group

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration of treatment / exposure:
13 Weeks
Frequency of treatment:
5 times per week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
0.2 mg/kg bw/day (nominal)
Dose / conc.:
2 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5 Animals per dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
At low dose and high dose, reduced body weight
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
At low dose and high dose, reduced feed intake
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
Dry / Haematological: low dose - Amino laevulinicacid dehydrogenase high dose - not specified
Behaviour (functional findings):
effects observed, treatment-related
Description (incidence and severity):
excitability, irritability, tremors, coma
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
At low and high dose: brain lesions and spinal cord, eosinophilic inclusions in prox. Renal tubular

Effect levels

Dose descriptor:
LOAEL
Effect level:
0.2 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
body weight and weight gain
food consumption and compound intake
gross pathology

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Repeat oral toxicity study carried out on groups of male rats, concluded that the first signs of toxicological effects due to TEL were observed at a dose rate of 0.2 mg/kg bw/d.
Executive summary:

Repeat oral toxicity study carried out on groups of male rats, concluded that the first signs of toxicological effects due to TEL were observed at a dose rate of 0.2 mg/kg bw/d.

An additional early study (21 weeks, oral, rats) by Schepers (1964b) supports the LOAEL identified in Franklin et al. (1987).