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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 june -3 Sep 08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD and EC guidelines and accordine to GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
324763-39-5
EC Number:
608-745-9
Cas Number:
324763-39-5
IUPAC Name:
324763-39-5
Constituent 2
Reference substance name:
4-[(2R)-2-(Chloromethyl)-3-methylbutyl]-1-methoxy-2-(3- methoxypropoxy) benzene
IUPAC Name:
4-[(2R)-2-(Chloromethyl)-3-methylbutyl]-1-methoxy-2-(3- methoxypropoxy) benzene
Details on test material:
Name of test material (as cited in study report): SPP100B1
- Substance type: White powder
- Physical state: powder
- Analytical purity: 99.5%
- Purity test date: not stated
- Lot/batch No.: c0446
- Expiration date of the lot/batch: 30 Aug 2008
- Stability under test conditions: stable
- Storage condition of test material: in refrigerator in the dark

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Corn oil
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
nominal conc.
500,1000,2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The substance is not clastogenic nor aneugenic in the study.