Nonanedioic acid, 1,9-bis(2-octyldodecyl) ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

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 1

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Reference 2

Reference Type:

publication

Title:

Single Dose Oral Toxicity Test of Bis(2-ethylhexyl) azelate in Rats

Author:

Shirota, M.

Year:

2003

Bibliographic source:

Toxicity Testing Reports of Environmental Chemicals, 11, 287-320

Reference 3

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 4

Reference Type:

secondary source

Title:

Bis(2-ethylhexyl) azelate

Author:

OECD

Year:

2006

Bibliographic source:

SIDS Initial Assessment Report for SIAM 22, Paris, France, 18-21 April, 2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

103-24-2 (analytical purity 77.2%)

IUPAC Name:

103-24-2 (analytical purity 77.2%)

Details on test material:

- Name of test material (as cited in study report): Bis(2-ethylhexyl)nonanedioate
- Analytical purity: 77.2%
- Impurities (identity and concentrations):
Bis(2-ethylhexyl)glutarate 2.2%,
Bis(2-ethylhexyl)adipate 2.4%,
Bis(2-ethylhexyl)pimelate 2.8%,
Bis(2-ethylhexyl)suberate 3.8%,
Bis(2-ethylhexyl)sebacate 3.3%,
Bis(2-ethylhexyl) 1-,9-nonamethylenedicarboxylate 5.3%,
Bis(2-ethylhexyl)1-,10-decamethylenedicarboxylate 0.6%,
Bis(2-ethylhexyl)1-,11-undecamethylenedicarboxylate 0.3%
- Lot/batch No.: N-31101

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Details on strain: Crj:CD(SD)IGS
- Source: Charles River Laboratories Japan, Inc., Yokohama, Japan
- Age at study initiation: 5 weeks
- Fasting period before study: from 4 pm one day before administration to 3 hours after administration
- Diet: CRF-2 (CLEA Japan, Meguro, Japan), ad libitum except fasting period
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 24
- Humidity (%): 50.5 - 62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed hourly up to 6 h post administration and once daily thereafter (including
weekends and holidays), and individual body weights were determined on Day 1, 2, 4, 8, 11 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Student's t- test, Aspin-Welch test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Soft faeces were observed in control groups of both sexes after 1 to 6 hours of administration. But no other clinical signs were evident in male and female rats.

Gross pathology:

Cysts in right kidney were found in one male of control group. But no other abnormal changes were noted at necropsy in other males and females.

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