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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
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:
no guideline followed
Principles of method if other than guideline:
Method not available
GLP compliance:
yes

Test material

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

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Duration of treatment / exposure:
13 wk
Frequency of treatment:
6 hr/d, 5 d/wk
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 15, 50 or 150 ppm
Basis:

No. of animals per sex per dose:
Male and female B6C3F1 mice (n = 10 per group)
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
15 ppm
Basis for effect level:
body weight and weight gain

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

IR analysis demonstrated that the mean concentration of PDC within the chamber (SD in brackets) was 0, 15(1), 50(3) or 151(3) ppm.

Clinical observations and body weight

No clinical signs or evidence of overt toxicity were recorded in any of the treated animals, while body weights were indistinguishable from those of the controls.

Haematology

RBC and HGB were slightly but significantly decreased (approx. 5%) in low and high dose male mice (no effect at 50 ppm, all treated females indistinguishable from controls). PCV was statistically significantly increased in low dose animals (no effect in mid and high dose groups). The authors concluded these findings were of doubtful toxicological relevance given the lack of a clear dose-response relationship and an absence of histopathological involvement in bone marrow or spleen. All other heamatological parameters were comparable between the control and treated animals.

Necropsy findings

Body weight and organ weights (relative and absolute) were unaffected by treatment.

Histopathology

No treatment related histopathological changes were present.

Applicant's summary and conclusion

Conclusions:
No adverse treatment related changes were noted in male and female B6C3F1 mice following whole body exposure to to 0, 15, 50 or 150 ppm PDC for 13 wk (NOAEL = 150 ppm).