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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Mating Index of mice
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)

Data source

Reference
Reference Type:
publication
Title:
Absence of mutagenic effects after treatment of mice with lead compounds
Author:
Kennedy, G.L., Arnold, D.
Year:
1971
Bibliographic source:
Newsletter Environ. Mut. Soc. Vol 5, pp 37

Materials and methods

Principles of method if other than guideline:
10 males per group were treated with a single dose po (6.48 and 32 mg TEL / kg) or ip (0.65 and 3.2 mg TEL / kg) and then paired with four females per week over six weeks.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: feed
Details on mating procedure:
Treated males were paired with four females per week over six weeks
Duration of treatment / exposure:
Exposure period: single dose
Premating exposure period (males): Single dose
Premating exposure period (females): no t applicable
Duration of test: 6 weeks
Frequency of treatment:
Single dose
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.65 & 3.2 mg TEL / kg
Basis:

Remarks:
Doses / Concentrations:
6.48 & 32 mg TEL /kg
Basis:

No. of animals per sex per dose:
10
Control animals:
not specified

Results and discussion

Results: P0 (first parental animals)

Reproductive function / performance (P0)

Reproductive performance:
effects observed, treatment-related
Description (incidence and severity):
Reduced the mating index during the first two weeks

Effect levels (P0)

Dose descriptor:
LOAEL
Effect level:
3.2 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Remarks on result:
other: Generation not specified (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

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.

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.

Applicant's summary and conclusion

Conclusions:
An LOAEL of <3.2 mg/kg bw is reported

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.
Executive summary:

An LOAEL of <3.2 mg/kg bw is reported

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.

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.