Diisodecyl sebacate

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study on a read-across compound, only briefly described in the secondary literature

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1983

Reference 3

Reference Type:

review article or handbook

Title:

Toxicity profile. Di(2-ethylhexyl) sebacate

Author:

Bibra

Year:

1996

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Groups of 12 rats were exposed to DEHS at 25 or 250 mg/m3, 4 hrs/day, 5 days/wk for 13 wk.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

di-(2-ethylhexyl) sebacate

IUPAC Name:

di-(2-ethylhexyl) sebacate

Constituent 2

Reference substance name:

Bis(2-ethylhexyl) sebacate

EC Number:

204-558-8

EC Name:

Bis(2-ethylhexyl) sebacate

Cas Number:

122-62-3

IUPAC Name:

bis(2-ethylhexyl) sebacate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): di(2-ethylhexyl) sebacate
- Molecular formula (if other than submission substance): C26-H50-O4
- Molecular weight (if other than submission substance): 426.677
- Smiles notation (if other than submission substance): C([C@@H](CCCC)CC)OC(CCCCCCCCC(OC[C@@H](CCCC)CC)=O)=O
- InChl (if other than submission substance): InChI=1S/C26H50O4/c1-5-9-17-23(7-3)21-29-25(27)19-15-13-11-12-14-16-20-26(28)30-22-24(8-4)18-10-6-2/h23-24H,5-22H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: no data in citing source
- Physical state: no data in citing source
- Analytical purity: no data in citing source
- Impurities (identity and concentrations): no data in citing source
- Composition of test material, percentage of components: no data in citing source
- Isomers composition: no data in citing source
- Purity test date: no data in citing source
- Lot/batch No.: no data in citing source
- Expiration date of the lot/batch: no data in citing source
- Stability under test conditions: no data in citing source
- Storage condition of test material: no data in citing source

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data in citing source
- Age at study initiation: no data in citing source
- Weight at study initiation: no data in citing source
- Fasting period before study: no data in citing source
- Housing: no data in citing source
- Diet (e.g. ad libitum): no data in citing source
- Water (e.g. ad libitum): no data in citing source
- Acclimation period: no data in citing source

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data in citing source
- Humidity (%): no data in citing source
- Air changes (per hr): no data in citing source
- Photoperiod (hrs dark / hrs light): no data in citing source

IN-LIFE DATES: no data in citing source

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

not specified

Remarks on MMAD:

MMAD / GSD: No data in citing source

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: no data in citing source
- Method of holding animals in test chamber: no data in citing source
- Source and rate of air: no data in citing source
- Method of conditioning air: no data in citing source
- System of generating particulates/aerosols: no data in citing source
- Temperature, humidity, pressure in air chamber: no data in citing source
- Air flow rate: no data in citing source
- Air change rate: no data in citing source
- Method of particle size determination: no data in citing source
- Treatment of exhaust air: no data in citing source

TEST ATMOSPHERE
- Brief description of analytical method used: no data in citing source
- Samples taken from breathing zone: no data in citing source

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data in citing source.

Duration of treatment / exposure:

13 wk

Frequency of treatment:

4 hr/day, 5 days/wk

Doses / concentrations

Remarks:

Doses / Concentrations:
25 or 250 mg/m3
Basis:
no data

No. of animals per sex per dose:

Total of 12 animals of unspecified sex in each of the two groups.

Control animals:

not specified

Details on study design:

- Dose selection rationale: no data in citing source
- Rationale for animal assignment (if not random): no data in citing source
- Rationale for selecting satellite groups: from citing sources, satellite groups don't appear to have been selected
- Post-exposure recovery period in satellite groups: from citing sources, satellite groups don't appear to have been selected
- Section schedule rationale (if not random): no data in citing source

Positive control:

No data in citing source.

Examinations

Observations and examinations performed and frequency:

Rats were apparently assessed 1, 7 and 13 weeks after exposure, but no further details are given on any of the examinations performed.

Sacrifice and pathology:

GROSS PATHOLOGY: no data in citing source
HISTOPATHOLOGY: no data in citing source

Other examinations:

No data in citing source.

Statistics:

No data in citing source.

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

A secondary source, compiled prior to the results of this study being subject to final analysis, stated that "no significant effects appear evident". Presumably there were no severe treatment-related clinical signs of toxicity, and no treatment-related mortality, but no specific details are given. The finalised results of this study may not have been formalised.

Effect levels

Dose descriptor:

NOAEL

Effect level:

ca. 250 mg/m³ air

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Apparently no observed adverse effects at highest tested concentration

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

In a study very briefly described in the secondary literature, no adverse effects were evidently observed in rats following inhalation exposure to DEHS for 13 weeks, resulting in a study NOAEC of 250 mg/m3.

Executive summary:

A subchronic inhalation study has been conducted on DEHS, a structurally-related read-across compound for DIDS, and is reported very briefly in the secondary literature.

Groups of 12 rats were treated with DEHS at either 25 or 250 mg/m3 for 4 hours/day, 5 days/week, for 13 weeks. Rats were apparently "assessed" after 1, 7 and 13 weeks of exposure [no details are given on the extent of examination, and presumably more frequent assessments were also performed e.g. for mortality and clinical signs of toxicity].

According to a secondary source, final analysis of the data has not been formalised. However, no significant adverse effects were evidently reported [no further details given], therefore a study NOAEC of 250 mg/m3 can be assumed.