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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to a guideline study conducted on a read-across material.
Justification for type of information:
The toxicological profile of the test material would not be different than that of codeine and the data are interchangeable. Codeine toxicology data is used to support the registered substance’s products in regulatory submissions. The test material is the sulfate salt form of codeine, a naturally occurring phenanthrene alkaloid and opioid agonist with analgesic, antidiarrheal, and antitussive activity.

Data source

Reference
Reference Type:
publication
Title:
NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF CODEINE (CAS NO. 76-57-3) IN F344/N RATS AND B6C3Fl MICE (FEED STUDIES)
Author:
NATIONAL TOXICOLOGY PROGRAM
Year:
1996
Bibliographic source:
NIH Publication No. 96-3360

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The mutagenicity potential of the test material was assessed in Salmonella typhimurium tests using strains TA97, TA98, TA100 or TA1535 with or without metabolic activation with S9 mix from Aroclor 1254-inducted male Sprague-Dawley rat or Syrian hamster liver, for 20 minutes at 37 °C in triplicate. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37° C.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

1
Reference substance name:
Codeine
EC Number:
200-969-1
EC Name:
Codeine
Cas Number:
76-57-3
Molecular formula:
C18H21NO3
IUPAC Name:
Codeine

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA97, TA98, TA100 and TA1535
Metabolic activation:
with and without
Metabolic activation system:
S9-mix

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium strains TA97, TA98, TA100 and TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test the test material was not mutagenic in any of four strains of Salmonella typhimurium, with or without S9 metabolic activation enzymes.
Executive summary:

The mutagenicity potential of the test material was assessed in Salmonella typhimurium tests using strains TA97, TA98, TA100 or TA1535 with or without metabolic activation with S9 mix from Aroclor 1254-inducted male Sprague-Dawley rat or Syrian hamster liver, for 20 minutes at 37 °C in triplicate. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37° C.

The test material was not mutagenic in any of four strains of Salmonella typhimurium, with or without S9 metabolic activation enzymes.