Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Rat (Rattus norvegicus) / CD / Crl: CD(SD)
Sex:
female
Details on test animals 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:
None
Body weight:
None
All animals gained the expected body weight at the end of the study period.
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.