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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Paraffin waxes and Hydrocarbon waxes, chloro
EC Number:
264-150-0
EC Name:
Paraffin waxes and Hydrocarbon waxes, chloro
Cas Number:
63449-39-8
Molecular formula:
C18H33Cl5 C18H30Cl8 C20H36Cl6 C20H33Cl9 C25H45Cl7 C25H42Cl10 C25H29C23 C30H53Cl9 C30H49Cl13 C30H35Cl27
IUPAC Name:
Paraffin waxes and Hydrocarbon waxes (C18 and longer), chloro
Details on test material:
C22-26; 43% Cl (liquid).

Test animals

Species:
rat
Strain:
other: Charles River COBS CD rats

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
Groups of 25 pregnant female rats were given the test substance at doses of 0, 500, 2000 or 5000 mg/kg bw/day orally by gavage, using a constant dose volume of 5 ml/kg bw, as a single daily dose on days 6 through to 19 of gestation.
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
One female and one male rat of the same strain and source were place together for matting. The occurrence of copulation was determined by the daily inspection for a copulaotry plug. Evidence of a copulatory plug was designated as day 0 for the study.
Duration of treatment / exposure:
6th - 19th day of gestation
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
500, 2000, 5000 mg/kg/day
Basis:

No. of animals per sex per dose:
25
Control animals:
yes, concurrent no treatment

Examinations

Maternal examinations:
Females were observed daily for mortality and signs of toxicity. Body weights were recorded on gestation days 0, 6, 9, 12, 16, and 20. On day 28 all females were sacrificed and uterus and ovaries were exposed by abdominal incision.
Ovaries and uterine content:
Uterine examinations were conducted on all surviving rats on day 20 of gestation.
Fetal examinations:
All fetuses were individually weighed and examined for external malformation and variations. Half of the fetuses were place in Bouin's solution for subsequent soft tissue examination using the Wilson razor-blade technique.
Statistics:
Level of significance at p <0.05. Chi-square with Yates correction and/or Fisher's exact probability as described by Siegel were used.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
No treatment related effects observed in the dams. One high-dose dam died late in gestation but a cause of death could not be determined.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
5 000 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No teratogenic effects.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
5 000 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAELs for maternal toxicity and teratogenicity were 5000 mg/kg/day (top dose).
Executive summary:

NOAELs for maternal toxicity and teratogenicity were 5000 mg/kg/day (top dose).