1,4-Cyclohexanedicarboxylic acid, 1,4-diisononyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10.12.2015 to 07.07.2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis(7-methyloctyl) cyclohexane-1,4-dicarboxylate

Cas Number:

313644-32-5

Molecular formula:

C26H48O4

IUPAC Name:

1,4-bis(7-methyloctyl) cyclohexane-1,4-dicarboxylate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Rat (Rattus norvegicus) / CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Species / Strain / Stock: Rat (Rattus norvegicus) / CD / Crl: CD(SD)
Supplier: Charles River Laboratories, Research Models and Services, Germany GmbH Sandhofer Weg 7, 97633 Sulzfeld Germany
Selection of species International recommendations; EC, OECD and OCSPP (OPPTS) guidelines
Sex: Female
Number of animals: 6 female animals
Group: 1 dose level group of 6 female animals - Limit test -
Body weight (at start of 1st administration): 167 - 188 g
Age (at start of administration): Approx. 8 weeks
Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages.
Diet: ad libitum
Water: ad libitum
Acclimation period: At least 5 adaptation days
Identification of animals: By coloured marks and cage label
Duration of experiment: At least 5 adaptation days, 1 test day, 2 recovery weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12 to 18-fold air change per hour
- Photoperiod (hrs dark / hrs light): The rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

IN-LIFE DATES: From: 14.12.16 To: 31.12.16

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Administration volume: 2.11 mL/kg b.w.

Doses:

2000 mg/kg b.w. (limit test)

No. of animals per sex per dose:

1 dose level group of 6 female animals - Limit test -

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this experiment Diisononyl 1,4-cyclohexanedicarboxylate (DINCD) was examined
for acute toxicity after a single oral administration to rats.
Under the present test conditions, a single oral administration of 2000 mg
Diisononyl 1,4-cyclohexanedicarboxylate (DINCD)/kg b.w. did not reveal any signs
of toxicity in any of the six female animals.
All animals gained the expected body weight at the end of the study period.
No pathological changes were observed at necropsy.
The LD50 value was ranked exceeding 2000 mg/kg b.w.