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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Experimental data in peer reviewed paper.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
not specified
Type of assay:
mammalian germ cell cytogenetic assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethylhept-5-enal
EC Number:
203-427-2
EC Name:
2,6-dimethylhept-5-enal
Cas Number:
106-72-9
Molecular formula:
C9H16O
IUPAC Name:
2,6-dimethylhept-5-enal
Test material form:
other: liquid
Details on test material:
The test material, B-212, a clear, pale-yellow liquid, was received from the sponsor on December 8, 1988, and stored under refrigeration and protected from light. Corn oil, (Lot# L-775), a clear yellow liquid was received from Schenck' s Food Company on December 2, 1987, and stored under refrigeration.

Test animals

Species:
mouse
Strain:
NMRI
Details on species / strain selection:
Standard strain.
Sex:
male/female
Details on test animals or test system and environmental conditions:
NA

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Olive oil
Details on exposure:
Treated twice at 0 hours and 24 hours.
Duration of treatment / exposure:
Treated twice at 0 hours and 24 hours. Bone marrow assessed at 48 hours.
Frequency of treatment:
Twice
Post exposure period:
48 hours.
Doses / concentrationsopen allclose all
Dose / conc.:
1 540 mg/kg bw/day
Dose / conc.:
980 mg/kg bw/day
Dose / conc.:
420 mg/kg bw/day
Dose / conc.:
0 mg/kg bw/day
No. of animals per sex per dose:
4
Control animals:
yes, concurrent vehicle
Positive control(s):
Not considered as the test was performed in a paper.

Examinations

Tissues and cell types examined:
Bone Marrow.
Details of tissue and slide preparation:
As per Salamone, Heddle, Stuart and Katz 1980.
Evaluation criteria:
As per Kastenbaum and Bowman 1970.
Statistics:
As per Kastenbaum and Bowman 1970.

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not valid
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
other: Scientifcally performed as per the guidance at the time.
Additional information on results:
For each of the four test groups all four of the treated mice survived. It was therefore concluded that the test substance 2,6-dimethylhept-5-enal did not exhibit cytogenetic damage up to the tested dose of 1540 mg/kg bw.

Applicant's summary and conclusion

Conclusions:
For each of the four test groups all four of the treated mice survived. It was therefore concluded that the test substance 2,6-dimethylhept-5-enal did not exhibit cytogenetic damage up to the tested dose of 1540 mg/kg bw.
Executive summary:

It was concluded that the test substance 2,6-dimethylhept-5-enal did not exhibit cytogenetic damage up to the tested dose of 1540 mg/kg bw.