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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: standard NTP methodology
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name. 1,2-dichloropropane

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
14 days
Frequency of treatment:
Consecutive days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 125, 250, 500, 1000 or 2000 mg/kg bw/d
Basis:

No. of animals per sex per dose:
Groups of 5 male and 5 female
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

open allclose all
Key result
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
mortality
Key result
Dose descriptor:
LOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
mortality

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

GC analysis of the dosing solutions demonstrated that the achieved concentration was 95 - 100% of target. All rats given 2000 mg/kg bw died during the study, along with a single male from the 125 mg/kg bw/d group. Final mean body weight was decreased 14-15% in animals given 1000 mg/kg bw/d relative to the controls. The renal medullae were red in 4/5 males and 5/5 females given 2000 mg/kg bw/d but not in rats from the lower treatment groups.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the sub-acute NOEL for PDC in male and female rats was 500 mg/kg bw/d.