Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: mutations were not specified
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No experimental deails available. The negative result was provided as reference.

Data source

Reference
Reference Type:
publication
Title:
Mutagen assay with Arabinopsis A report of the U.S. Envioronmental Protection Agency Gene-Tox Program
Author:
Rédei, GP
Year:
1982
Bibliographic source:
Mutation Research, 99 (1982) 243 - 255

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Experimental details were not provided.
GLP compliance:
no
Type of assay:
other: Arabinopsis thaliana

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no information available.

Test animals

Species:
other: Arabinopsis thaliana, a plant
Details on test animals and environmental conditions:
Arabinopsis thaliana is a plant which was often used as biological model organism. No further data on the test plants and the experimental conditions were provided.

Administration / exposure

Route of administration:
other: not provided
Details on exposure:
no details were provided
Doses / concentrations
Remarks:
Doses / Concentrations:
500 mM
Basis:
no data
Information given as "highest negative" concentration

Results and discussion

Any other information on results incl. tables

According to a cited reference (Müller, A.J. (1965) Arabinopsis Inf. Serv., 2, 22 - 24), the highest negative concentration of DEC is 500 mM. Further details were not provided.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative since no positive finding was reported
According to this Klimisch 4 information, the plant Arabinopsis thaliana showed no mutagenicity up to a concentration of 500 mM. further information was not provided.
Executive summary:

Rédei (1982) cited a publication from Müller (Müller, A.J. (1965) Arabinopsis Inf. Serv., 2, 22 - 24) in which the mutagenic potential of DEC on the plant Arabinopsis thaliana was evaluated. No experimental details were provided. It was stated that the highest concentration without mutagenic effects was 500 mM. Due to the very limited information on test material, experimental design, results and evaluation it is not possible to evaluate the relevance of this information. Therefore, this information was regarded as Klimisch 4 and will not be used for the risk assessment of DEC.