Dibutyl sebacate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

31 Jan - 10 Apr 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles. Purity of test substance not given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

purity of test substance not given

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

Version / remarks:

purity of test substance not given

Deviations:

yes

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

69275-01-0

Cas Number:

69275-01-0

IUPAC Name:

69275-01-0

Details on test material:

- Name of test material (as cited in study report): Di-(2-octyl-dodecyl)-sebacate
- Physical state: colorless liquid
- Storage condition of test material: room termperature
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: oleum Arachidis, DAB8

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

28 days (control and test groups)
Additional animals (5/sex/group) for both the control and the high dose group were maintained for further 28 treatment-free days, for purpose of recovery testing.

Frequency of treatment:

once daily, 5 days a week

Doses / concentrations

Remarks:

Doses / Concentrations:
100, 350 and 1000 mg/kg bw/d (group 2, 3 and 4, respectively)
Basis:
actual ingested

No. of animals per sex per dose:

test groups: 10
recovery groups (control, high dose group): 5

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

>= 1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: NOAEL corresponding to the highest dose tested.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Table 3: Mean body weight and body weight gain values (g) of rats treated with the test item in the feed for 28 days:

body weight gain
	males				females
week	control	100 mg/kg bw	350 mg/kg bw	1000 mg/kg bw	control	100 mg/kg bw	350 mg/kg bw	1000 mg/kg bw
0	158	159	165	158	136	139	137	141
1	210	211	220	214	158	163	164	166
2	267	271	280	269	179	184	189	190
3	315	323	332	323	193	203	209*	209*
4	355	362	373	262	202	217*	225**	225**
gain 0-4	197	203	208	204	66	78	88	84

*significant different (p>0,05); **significant different (p>0.01)