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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:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study without detailed documentation (publication).

Data source

Reference
Reference Type:
review article or handbook
Title:
The toxicity of behenyl alcohol: II. Reproduction studies in rats and rabbits
Author:
Iglesias G, JJ Hlywka, JE Berg, MH Khalil, LE Pope and D Tamarkin
Year:
2002
Bibliographic source:
Regulatory Tox. and Pharm. 36, 80-85 2002b

Materials and methods

Principles of method if other than guideline:
Method: other
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
C22 alcohol CAS RN 661-19-8

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
For 15 days prior to mating, during mating and up to Day 17 of gestation.
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
10, 100, 1000 mg/kg bw
Basis:

Control animals:
yes
Details on study design:
Sex: female
Duration of test: 20th day of gestation

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

All female rats survived to sacrifice and no maternal toxicity was  observed. The were no differences between treated and control animals in  any of the rerpoductive endpoints investigated (corpora lutea, pre & post  implantation sites, early & late resorption sites).  The litter size,  foetal weight and sex ratio observed in treated groups was comparable to  the control group.  There were no unusual macroscopic findings among  foetuses. Microscopic examination did not show any increased incidence of  anomalies in skeletal or soft tissues. See above chapter 5.8.1 for  further details.

Applicant's summary and conclusion

Conclusions:
1000 mg/kg/day is the NOAEL for maternal toxicity, teratogenicity and foetotoxicity in rats receiving behenyl alcohol by gavage for 15 days premating, during mating and up until gestation day 17. This is based on the absence of adverse effects in any of the parental, reproductive or foetal parameters examined.