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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
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:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No details given.
GLP compliance:
not specified

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:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
4 week study
Frequency of treatment:
Every day
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 30, 60mg/kg/day
Basis:

Details on study design:
Groups of 20 Sprague-Dawley rats of each sex were given 3-chloro-1,2-propanediol at a dose of 0, 30, or 60 mg/kg bw per day by gavage on 5 days per week for 4 weeks. Ten animals of each sex from each group were killed on day 2, and their blood was examined for clinical chemical parameters.

Examinations

Observations and examinations performed and frequency:
After 2 days of treatment, the relative weight of the kidney was increased in males at the higher dose and in females at both doses, and on day 25, the relative weights of the kidney, liver, and testis (males at the higher dose) were significantly increased in treated rats.
Histopathological examination revealed chronic progressive nephropathy in eight females at the higher dose and mild tubule dilatation in the testis of three males at the lower dose and seven at the higher dose. One male at the higher dose had severe atrophy of both testes.

Results and discussion

Effect levels

Dose descriptor:
LOAEL
Effect level:
30 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
clinical signs
organ weights and organ / body weight ratios

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The substance is toxic by ingestion over prolonged exposure.