Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16.02.2010 to 21.12.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
EC Number:
700-453-0
Cas Number:
59802-05-0
Molecular formula:
C26H42O4
IUPAC Name:
1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Crl:CD´SD`
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd
- Females nulliparous and non-pregnant: yes
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 202 to 238 g
-Fasting period: overnight prior to and approximately four hours after dosing
- Housing: Animals were housed inside a barriered rodent facility
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark per
24 hours.

IN-LIFE DATES: From: 28/10/2010 To: 18/11/2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test substance was formulated at a concentration of 200 mg/mL in the vehicle and administered at a volume of 10 mL/kg bodyweight.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.

- Other examinations performed: clinical signs, body weight,histopathology

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.
Clinical signs:
There were no clinical signs of reaction to treatment throughout the study.
Body weight:
A low bodyweight gain was noted for one female (No. F1) and a bodyweight loss for one
female (No. F5) on Day 15. All other animals were considered to have achieved satisfactory
bodyweight gains throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination at study
termination on Day 15.

Applicant's summary and conclusion

Conclusions:
The acute median lethal oral dose (LD50) to rats of Bis(C9 (branched)alkyl)benzene-1,4-dicarboxylate
was demonstrated to be greater than 2000 mg/kg bodyweight.