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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature. Original report not available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
Author:
US-EPA (American Chemistry Council's Aliphatic Esters Panel)
Year:
2010
Bibliographic source:
High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)
Reference Type:
secondary source
Title:
Toxicity Profile for Di(2-ethylhexyl) Sebacate
Author:
British Industrial Biological Research Association (BIBRA)
Year:
1996
Bibliographic source:
as cited in US-EPA (2010) Diesters Category of the Aliphatic Esters Chemicals

Materials and methods

Principles of method if other than guideline:
1, 7, or 13-week inhalation study, no further details given.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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:
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
not specified

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remarks on MMAD:
MMAD / GSD: no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
1, 7, or 13 weeks
Frequency of treatment:
5 days/week; 4 h/day
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
25 and 250 mg/m³
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
0.025 and 0.25 mg/L
Basis:
nominal conc.
No. of animals per sex per dose:
12 rats/dose
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOAEC
Effect level:
250 mg/m³ air (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse systemic or lung effects at the highest concentration

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

There were no adverse systemic or lung effects seen in groups of 12 rats exposed to up to 250 mg/m³ for 4 h/day, 5 days/week for 13 weeks.

Applicant's summary and conclusion