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Toxicological information

Repeated dose toxicity: oral

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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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals 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).