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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Combined repeat dose and reproductive/developmental toxicity screening test.
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Collection of data from an OECD SIDS Report.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
1-Dodecanol (Cas# 112-53-8)
Author:
OECD SIDS
Year:
1998
Bibliographic source:
SIDS Initial Assessment Report on 1-Dodecanol, link: http://www.chem.unep.ch/irptc/sids/OECDSIDS/112538.pdf
Reference Type:
publication
Title:
Combined Repeat Dose and Reproductive/Developmental Toxicity Screening Test on 1-Dodecanol in Rats
Author:
Hansen E.
Year:
1992
Bibliographic source:
Institute of Toxicology, Danish National Food Agency, July 30, 1992, IT 921105.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no data

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Details on mating procedure:
After 14 days of dosing, females were placed together with the males. Females in which no mating was recorded were kept together with the same male for a 14 day period. If no plug and no indication of pregnancy was found after a 14-day period, the female rat was placed together with another male for an 8-day period.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
See mating procedure
Frequency of treatment:
Daily
Details on study schedule:
No further data.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 500 and 2000 mg/kg/by/day
Basis:
nominal in diet
No. of animals per sex per dose:
12
Control animals:
yes

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
body weight and weight gain
food consumption and compound intake
food efficiency
organ weights and organ / body weight ratios

Results: P1 (second parental generation)

Effect levels (P1)

Remarks on result:
not measured/tested

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
2 000 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
sexual maturation
mortality
body weight and weight gain
gross pathology
other: number of pups per litter

Results: F2 generation

Effect levels (F2)

Remarks on result:
not measured/tested

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
1-Dodecanol showed no adverse reproductive effects in rats at dose levels up to and including 2000 mg/kg bw/day..