Bis(2-ethylhexyl) sebacate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 Feb - 18 Feb 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of details on test substance, no necropsy performed

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) sebacate

EC Number:

204-558-8

EC Name:

Bis(2-ethylhexyl) sebacate

Cas Number:

122-62-3

Molecular formula:

C26H50O4

IUPAC Name:

bis(2-ethylhexyl) sebacate

Details on test material:

- Name of test material (as cited in study report): Di-Octyl Sebacate
- Analytical purity: No data

Test animals

Species:

rat

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult, not further specified
- Weight at study initiation: 200-239 g
- Fasting period before study: 24 h
- Housing: Common cages
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
5mL/kg bw

Doses:

5 mL/kg bw equivalent to 4560 mg/kg bw at a density of 0.912 g/mL at 25 °C (Croda 2008; see chapter 4.4).

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made daily for a two week period.
- Necropsy of survivors performed: no
- Other examinations performed: Eating patterns, behaviour patterns

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Based on:

test mat.

Remarks on result:

other: original value in mL/kg as given in the study report

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 560 mg/kg bw

Based on:

test mat.

Remarks on result:

other: density 0.912 g/mL at 25 °C

Mortality:

No mortality occurred during the observation period.

Clinical signs:

other: Slight diarrhoea was accompanied with wet, oily coats, which normally prevailed during 96 hours. Eating habits and behaviour patterns remained unchanged during the observation period.

Gross pathology:

Not examined

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified