Phenol, dodecyl-, branched

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:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1987

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

not specified

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, dodecyl-, branched

EC Number:

310-154-3

EC Name:

Phenol, dodecyl-, branched

Cas Number:

121158-58-5

Molecular formula:

Not appropriate. UVCB substance

IUPAC Name:

4-(3,4,5,6-tetramethyloctan-2-yl)phenol

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

other: No data

Duration of treatment / exposure:

Single dose

Frequency of treatment:

Single dose

Post exposure period:

up to 48 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 500, 1500 & 5000 mg/kg
Basis:
no data

No. of animals per sex per dose:

No data

Control animals:

yes

Positive control(s):

Cyclophosphamide-treated positive control group

Examinations

Tissues and cell types examined:

No data

Details of tissue and slide preparation:

No data

Evaluation criteria:

No data

Statistics:

No data

Results and discussion

Test results

Sex:

not specified

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

Mortality was observed at the high dose, and reduced body weight gain was observed in the mid- and high-dose groups. There was no evidence of chromosome damage as measured by increases in chromosome aberrations, altered mitotic index, or chromosome number when compared to the concurrent control group. In the cyclophosphamide-treated positive control group, a significant increase in the average number of aberrations, percent of cells with aberrations, and decreased mitotic index was observed confirming the sensitivity of the assay. Under the conditions of this study the test material is not clastogenic.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Under the conditions of this studythe test material is not clastogenic.

Executive summary:

The test material was evaluated in an In Vivo Rat Bone Marrow Assay similar to OECD Test Guideline 474.

The test material was administered to rats at dose levels of 0, 500, 1500, and 5000 mg/kg. Six rats/sex from each group were sacrificed at 6, 12, 24, and 48 hours after treatment. The bone marrow cells were aspirated from each femur and processed for cytogenetic analysis. Slides from five rats of each sex (60 cells per animal) were examined for chromosomal aberrations for the 6-, 12, and 24-hour groups. Sixty cells were examined per animal.

Mortality was observed at the high dose, and reduced body weight gain was observed in the mid- and high-dose groups. There was no evidence of chromosome damage as measured by increases in chromosome aberrations, altered mitotic index, or chromosome number when compared to the concurrent control group. In the cyclophosphamide-treated positive control group, a significant increase in the average number of aberrations, percent of cells with aberrations, and decreased mitotic index was observed confirming the sensitivity of the assay. Under the conditions of this studythe test material is not clastogenic.