1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene

Genetic toxicity: in vivo

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

Test material information

Constituent 1

Reference substance name:

1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene

EC Number:

236-948-9

EC Name:

1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene

Cas Number:

13560-89-9

Molecular formula:

C18H12Cl12

IUPAC Name:

1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro-1,4,4a,5,6,6a,7,10,10a,11,12,12a-dodecahydro-1,4:7,10-dimethanodibenzo[a,e][8]annulene

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 or test system 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.