Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is done similar to OECD TG 471, GLP status unknown. The information is from a published paper.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Remarks:
The substances have been tested in the labs where also the NTP program is carried out.
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Pinane
Biocyclo [3.1.1]heptane, 2,6,6 -trimethyl-
Cas no used: 473-55-2

Method

Species / strain
Species / strain:
other: TA98, TA100, TA97 and TA1535
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Details on test system and conditions:
The selected chemicals were tested under code using a preincubation modification of the Salmonella/mammalian microsome mutagenicity (Ames) test. The tests were perfomed in two laboratories under contract to the NTP. The test chemicals for this exercise were included among other chemicals being tested for the U.S. NTP, and, therefore, were treated as if they had been slected for routine testing. The protocol used, and the data evaluation criteria have been previously described (Zeiger et al. 1992). Briefly, chemicals were tested in a preincubation procedure in strains TA98 and TA100 without metabolic activation provided by Aroclor-induced rat and hamster liver homogenates (S9). If a positive response was seen in one of these two strains, the strain/metabolic activation combination producing that response was repeated, and no further testing was performed. If no positive responses were seen, the chemical was tested in strains TA97 and TA 1535. Other Salmonella strains were occasionally used based on the response obtained with these four strains.
Evaluation criteria:
Some chemicals were tested more than once. In some cases this was a result of the normal practice of testing occasional duplicates under different code numbers as a quality control of the accuracy of the testing laboratories. Some chemicals yielding equivocal responses were re-tested, under a different code numbers as a quality control of the accuracy of the testing laboratory. When the results from multiple testing on single chemicals were compiled for Table 2(attached), the combination of a questionable (?) and a negative (-) response were considered (-); the combination of weakly positive (+w) and negative response was considered questionable (?). The chemicals were not decoded until testing had been completed on a sample and the data had been accepted. The chemicals tested and their CASRNs are in Appendix 1 and 2 (attached).
Statistics:
The statistical sampling used in this study was a two stage, double sampling scheme for estimating binomial data with misclassifications. The first stage consisted of 675 chemicals obtained via a stratified random sample of the 65,725 NAS chemicals. At the second stage, 100 chemicals were chosen by a stratified random sample of the 675.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
other:
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
See Table 2-Summary Test Results (Attachment)
See Table 3-Proportions of Salmonella Mutagens in Different Datasets of Chemicals (Attachment)
Appendix 1-Test Chemicals and Salmonella Test Results (Attachement)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Pinane was not mutagenic, according to the test results published in this article.
Executive summary:

Pinane was one of the 100 substance tested in the Ames test, according to OECD TG 471, to address the question of the proportions of mutagens among all chemical in commerce. Pinane was negative in this test.

Zeiger, E., and Margolin, B.H., 2000, The Proportions of Mutagens among Chemicals in Commerce, Regulatory Toxicology and Pharmacology 32, 219–225