Registration Dossier

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Reproductive function and performance
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The result was obtained from a publically available source which has been subject to peer-review and in which the original data sources are traceable.

Data source

Reference
Reference Type:
publication
Title:
Safety evaluation of certain food additives and contaminants 3-chloro-1,2-propanediol
Year:
2011
Bibliographic source:
WHO FOOD ADDITIVES SERIES: 48

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Not given.
GLP compliance:
not specified
Remarks:
Details not provided

Test material

Constituent 1
Reference substance name:
3-chloropropane-1,2-diol
EC Number:
202-492-4
EC Name:
3-chloropropane-1,2-diol
Cas Number:
96-24-2
IUPAC Name:
3-chloropropane-1,2-diol
Constituent 2
Reference substance name:
3-Chloro-1,2-propanediol
IUPAC Name:
3-Chloro-1,2-propanediol

Test animals

Species:
rat
Strain:
other: CD
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Details on mating procedure:
Before the kill at day 15, the males were cohabited with untreated females in a 1:2 ratio. The females were killed on presumed gestational day 13 and examined for pregnancy status.
Duration of treatment / exposure:
3-Chloro-1,2-propanediol was administered by gavage to groups of 10 adult male CD rats at a dose of 0, 1, 5, or 25 mg/kg bw per day for 14 days. The animals were killed on day 15 or 29. At necropsy, testis weight, distribution of DNA ploidy in testicular cell suspensions, testicular and epididymal histological appearance, and epididymal sperm concentration, motility, morphology, and breakage were determined.
Frequency of treatment:
Daily.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0 mg/kg
Basis:

Remarks:
Doses / Concentrations:
1 mg/kg
Basis:

Remarks:
Doses / Concentrations:
5 mg/kg
Basis:

Remarks:
Doses / Concentrations:
25 mg/kg
Basis:

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

At the highest dose, minor decreases in body weight and relative food consumption were reported, and testicular and epididymal lesions were observed.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 mg/kg bw/day
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Reduced percentage of mobile sperm and decreased fertility
Remarks on result:
other: Generation: Unknown (migrated information)

Results: F1 generation

Effect levels (F1)

Dose descriptor:
other: No offspring
Generation:
F1
Effect level:
> 0 - <= 1 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: No offspring

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The substance impairs fertility in the rat.