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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: sufficient doumentd for evaluation

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Chemical mutagenesis testing in Drosophila: III. Results of 48 coded compounds tested for the national toxicology program
Author:
Valencia R, Mason JM, Woodruff RC, Zimmering S
Year:
1985
Bibliographic source:
Environ Mutagen 7, 325-348
Reference Type:
publication
Title:
Chemical mutagenesis testing in Drosophila: VIII. Reexamination of eyuivocal results
Author:
Mason JM, Valencia r, Zimmering S
Year:
1992
Bibliographic source:
Environ Mutagen 19, 227-234

Materials and methods

Principles of method if other than guideline:
Tetrachlorophthalic anhydride was tested in the Drosophila sex-linked recessive lethal (SLRL) assay
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
Drosophila melanogaster
Strain:
other: Canton-S-wild-type stock
Sex:
male/female

Administration / exposure

Route of administration:
other: feeding and injection
Duration of treatment / exposure:
feedling: 72 hours
injected: 24 hours
Frequency of treatment:
feeding: At 24 hr and again at 48 hr, the flies were transferred to vials with freshly prepared feeding mixture
injected: single injection
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
1000 ppm feeding; 500 ppm injection
Basis:
nominal conc.
No. of animals per sex per dose:
no data
Control animals:
yes, concurrent no treatment

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
ambiguous
Remarks:
feeding: questionable; injection: negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Compound: tetrachlorophthalic anhydride

Lethals (feeding) = ?

Lethals ( injection) = negative

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
Executive summary:

Tetrachlorophthalic anhydride was tested in the Drosophila sex-linked recessive lethal (SLRL) assay. The compound was tested first for the induction of sex-linked recessive lethals (SLRLs) by feeding the chemical in a solution of 5% aqueous sucrose. Afterwards the chemical was tested by injection in a solution of 0.7% aqueous NaCl.

In the feeding test an questionale result was obtainded. In the injection test tetrachlorophathalic anhydride was negative. In a reexamination of the test results by the authors (data were published in a follow-up publication) an equivocal test result for tetrachlorophathalic anhydrid was confirmed.

No data were available on the quality of the test substance (purity: practical). a reason for the questionale result in the feeding test and the negative result in the injection test was not evident. According to the authors, overall the test result is judged as equivocal.

Therefore the test result is not used for classification of TCPA.