Registration Dossier
Registration Dossier
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EC number: 201-933-8 | CAS number: 89-72-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2007
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Unpublished data
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report For CoCAM2
- Author:
- OECD SIDS
- Year:
- 2 012
Materials and methods
- GLP compliance:
- yes
- Type of assay:
- other: Micronucleus test
Test material
- Reference substance name:
- 2-sec-butylphenol
- EC Number:
- 201-933-8
- EC Name:
- 2-sec-butylphenol
- Cas Number:
- 89-72-5
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-(butan-2-yl)phenol
1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Oral gavage at doses of 0, 75, 150, 300, and 600 mg/kg bw/day.
- Duration of treatment / exposure:
- Administered twice
- Frequency of treatment:
- 24-h intervals
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- cyclophosphamide monohydrate
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- 2-sec-butylphenol did not induce chromosomal aberrations in bone marrow cells in rats.
- Executive summary:
The micronucleus test was conducted in accordance with current protocols (OECD TG 474) in male and female rats under GLP.This study was identified as a key study because it was well conducted[MHLW Japan, 2007 (unpublished data)].
2-sec-Butylphenol was administered twice with 24-h intervals by oral gavage to male and female Crj:CD(SD) rats (5 animals/sex/dose) at doses of 0, 75, 150, 300, and 600 mg/kg bw/day.
The frequency of appearance of micronucleated immature erythrocytes (MNPCE) increased significantly in male rats at 600 mg/kg bw/day but this increase was within the range of vehicle control background data in the testing facility. In female rats, there no significant increase in the number of micronucleated cells at any dose. Theproportion of PCE among the total erythrocyte populations was unchanged.It was concluded that 2-sec-butylphenol did not induce chromosomal aberrations in bone marrow cells in rats. The positive control (CP, cyclophosphamide monohydrate) showed expected results.
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