Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
24 hours
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Testing of the substance itself or its metabolites is not ensured, because urinary excretion of the test substance or its metabolites was not proven

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Rats were given Dechlorane Plus at dose levels of 500 or 1,000 mg/rat bw once orally by gavage, and the urine was collected for 24 hours thereafter. After addition of glucuronidase to hydrolyse glucuronides, the urine was tested in the Ames test with Salmonella typhimurium with and without metabolic activation.
GLP compliance:
no
Type of assay:
other: Ames test with urine of treated rats

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
Dechlorane Plus, no further details reported.

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
Bodyweight about 300 g, given food ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
none
Details on exposure:
single oral administration
Duration of treatment / exposure:
Single oral administration
Frequency of treatment:
Single oral administration
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
500 or 1,000 mg per animal
Basis:

No. of animals per sex per dose:
3 males per group
Control animals:
yes
Positive control(s):
3 males given 2-acetylaminofluorene at 40 mg/kg bw once intraperitoneally

Examinations

Tissues and cell types examined:
Urine was collected for 24 hours and assayed

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
other: vehicle not specified
Negative controls validity:
not specified
Positive controls validity:
other: Only two strains reacted positive
Additional information on results:
Negative results do not demonstrate the lack of genotoxicity, while positive results would demonstrate their presence. Test results can not be used for the evaluation of the genotoxicity of the test substance.

Any other information on results incl. tables

No increase in mutant frequency with urine from treated rats in any strain at any concentration with and without metabolic activation. Negative controls were clearly negative, but positive controls were only partly and moderately positive. It was not demonstrated, if the urine of treated rats contained the test substance or metabolites of it.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative cannot be used for evaluation due to false negatives in some positive controls
The results cannot be used for the evaluation of the genotoxicity of Dechlorane Plus
Executive summary:

Dechlorane Plus was administered once orally by gavage to groups of 3 male rats at dose levels of 500 or 1,000 mg/rat. Negative controls were given vehicle (unspecified), while positive controls were given 2-acetylaminofluorene at 40 mg/kg bw once intraperitoneally. The urine was collected over 24 hours and tested in the standard Ames plate incorporation test in Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538 with and without metabolic activation by rat liver S9-mix. No increase in mutant frequency was observed in urine-exposed cultures at any concentration in any strain with and without metabolic activation, but the presence of the test substance or its metabolites in urine was not verified. Positive controls were only partly and moderately positive, while negative controls were negative. This result cannot be used for the evaluation of the genotoxicity of Dechlorane Plus.