Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
LOAEL
3.2 mg/kg bw/day
Additional information

In a dominant lethal test on mice, 10 males per group were treated with a single dose of TEL p.o. (6.48 and 32 mg/kg bw) or i.p. (0.65 and 3.2 mg/kg bw) and then mated with 4 females per week for 6 weeks (Kennedy and Arnold, 1971). The preimplantation losses rose after an i.p. dose of 3.2 mg/kg bw between weeks 3 and 6 of mating. A significant increase in early resorptions was not observed. Oral administration of 32 mg/kg bw reduced the mating index during the first two weeks (Kennedy and Arnold, 1971).


Short description of key information:
The first signs of any effect due to TEL was that preimplantation losses rose after an i.p dose of 3.2 mg/kg bw

Effects on developmental toxicity

Description of key information
In reproductive toxicity studies on rats and mice, TEL had an embryotoxic effect at maternotoxic levels. 
TEL is not teratogenic to the mouse or rat.
Effect on developmental toxicity: via oral route
Dose descriptor:
LOAEL
1 mg/kg bw/day
Additional information

In reproductive toxicity studies on rats and mice, TEL had an embryotoxic effect at maternally toxic levels.[r1] (Kennedy et al. 1975).

A series of studies on rat and mice[r2] identified that developmental toxicity effects were observed at oral dose levels from 1 mg/kg bw/day, considered the LOAEL for developmental effects for the CSA. In rats and mice embryotoxic effect was detected only at maternally toxic doses (Kennedy et al. 1975).

Maternal toxicity was observed and foetal resorption and general retardation of development was encountered at the higher dose levels. TEL did not cause any congenital malformations. Foetuses derived from lead exposed females were examined grossly and for internal structural and skeletal development but no teratogenic response was evident, even at dose levels at which signs of maternal toxicity were observed. It is concluded that lead as TEL is not teratogenic to the mouse or rat.[r3] (Kennedy et al. 1975)

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Justification for classification or non-classification

The available data on TEL indicate that it caused developmental and reproductive toxicity in rodents, but only at doses that were maternally toxic (Kennedy et al. 1975;McClain and Becker, 1972).Under the EU DSD, lead alkyls are classified as Repr. Cat. 1 (R61 May cause harm to the unborn child) and Repr. Cat. 3 (R62 Possible risk of impaired fertility).Under GHS/CLP, lead alkyls are assigned the classification ¿Repr. 1A¿ (H360Df-May damage the unborn child. Suspected of damaging fertility).