Dibutyl sebacate

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:

key study

Study period:

13 Feb 2002 - 14 May 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

(adopted in 1997)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl adipate

EC Number:

203-350-4

EC Name:

Dibutyl adipate

Cas Number:

105-99-7

IUPAC Name:

dibutyl adipate

Details on test material:

- Name of test material (as cited in study report): Hexanedioic acid, Dibutyl ester; Adipinsäuredibutylester.
- Batch No: 13290016
- Physical state: colourless liquid
- Purity: 100 % active substance
- Stability in vehicle: not indicated by the sponsor
- Storage: at room temperature, light protected
- Expiration date: November, 2002

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Duration of treatment / exposure:

Single administration

Frequency of treatment:

Single administration

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
500, 1000, 2000 mg/kg bw
Basis:
actual ingested
for 24 h sampling

Doses / concentrations 2

Remarks:

Doses / Concentrations:
2000 mg/kg bw
Basis:
actual ingested
for 48 h sampling

No. of animals per sex per dose:

5
(6 animals per sex, group and sampling time were treated, and 5 were finally used for evaluation)

Control animals:

yes, concurrent vehicle

Examinations

Tissues and cell types examined:

Bone marrow cells

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Remarks:

2000 mg/kg bw group: 1 h post treatment reduction of spontaneous activity in 12/12, abdominal position in 3/12, eyelid closure in 4/12 and ruffled fur in 8/12 were evident the animals fully recovered within 24 h

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Table 1: Results of the in vivo micronucleus assay in NMRI mice (average values)

Experimental group	Number of animals (m/f)	Sampling time (hours after administration)	Dose (mg/kg bw)	PCEs with micronuclei (%)	Range of micronucleated cells per 2000 PCEs	PCE/NCE
Vehicle control (olive oil)	5/5	24	0	0.085	0 - 3	2000/1650
Positive control (Cyclophosphamide)	5/5	24	40	1.200	10 - 37	2000/2235
Test substance	5/5	24	500	0.065	0 - 4	2000/1677
Test substance	5/5	24	1000	0.135	0 - 7	2000/1686
Test substance	5/5	24	2000	0.040	0 - 5	2000/1719
Test substance	5/5	48	2000	0.090	0 - 3	2000/1776

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative