Registration Dossier
Registration Dossier
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EC number: 500-201-8 | CAS number: 68213-23-0 1 - 2.5 moles ethoxylated
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro and in vivo genetic toxicology studies with diethylene glycol monohexyl ether.
- Author:
- Ballantyne, B. & Vergnes, J.S.
- Year:
- 2 001
- Bibliographic source:
- J. Appl. Toxicol. 21, 449-460
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-(2-hexyloxyethoxy)ethanol
- EC Number:
- 203-988-3
- EC Name:
- 2-(2-hexyloxyethoxy)ethanol
- Cas Number:
- 112-59-4
- IUPAC Name:
- 2-[2-(hexyloxy)ethoxy]ethanol
- Details on test material:
- - Name of test material (as cited in study report): diethylene glycol monohexyl ether
- Ethoxylation degree: 2EO
- Physical state: No data
- Analytical purity: 96.8%
- Lot/batch No.: No data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- n.a.
- Frequency of treatment:
- single
- Post exposure period:
- 30, 48, 72 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 200, 400, 640 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Triethylenemelamine (0.3 mg/kg)
Examinations
- Tissues and cell types examined:
- Tail blood smears
- Details of tissue and slide preparation:
- Sampling time: 30, 48, 72 h
- Evaluation criteria:
- According to Guideline.
- Statistics:
- Yes
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 410-1000 mg/kg bw
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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