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Description of key information

Two acute toxicity tests were conducted, an oral and a dermal study. For both exposure routes, the acute oral median lethal dose (LD50) of the test material in rats was estimated to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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).
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07.06.2016 to 10.01.2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sulzfeld, Germany
-Number and sex of animals: 10 animals (5 males and 5 females, limit test)
Group: 1 dose level group of 5 males and 5 females
-Body weight (at dosing): Males: 252 - 265 g; Females: 229 - 246 g
-Age (at dosing): Males: approx. 8 weeks; Females: approx. 9 weeks
- Housing: During the 14-day observation period the animals were kept singly 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%
- 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: 23.09.2016 To: 19.10.2016
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: intact dorsal skin, animal´s back between the fore and hind extremities
- % coverage: approx. 1/10 of body surface
- Type of wrap if used: The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.1 mL/kg b.w.
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w. (limit test)
No. of animals per sex per dose:
One dose level group of 5 male and 5 female rats was examined (limit test).
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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: mortality, clinical signs, body weight, skin observation, gross pathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
One of the 5 female animals appeared to be reduced in body weight gain at the end of the study.
Gross pathology:
No signs of abnormalities were noted at necropsy.
Other findings:
No skin reactions were observed at the application site
Interpretation of results:
GHS criteria not met
Conclusions:
In this experiment Diisononyl 1,4-cyclohexanedicarboxylate (DINCD) was
examined for acute toxicity after a single dermal application to rats. One dose level
of 2000 mg/kg b.w. was employed (limit test).
Under the present test conditions, a single dermal administration of 2000 mg
Diisononyl 1,4-cyclohexanedicarboxylate (DINCD)/kg b.w. did not reveal any signs
of toxicity. No death was recorded within the test period (one dosing day and
14 days of recovery).
One of the 5 female animals appeared to be reduced in body weight gain at the
end of the study.
No skin reactions were observed at the application site.
No signs of abnormalities were noted at necropsy.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral toxicity study:

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 LD50value was ranked exceeding 2000 mg/kg b.w.

Acute dermal toxicity study:

In this experiment Diisononyl 1,4-cyclohexanedicarboxylate (DINCD) was examined for acute toxicity after a single dermal application to rats. One dose level of 2000 mg/kg b.w. was employed (limit test).

Under the present test conditions, a single dermal administration of 2000 mgDiisononyl 1,4-cyclohexanedicarboxylate (DINCD)/kg b.w. did not reveal any signs of toxicity. No death was recorded within the test period (one dosing day and 14 days of recovery).

One of the 5 female animals appeared to be reduced in body weight gain at the end of the study.

No skin reactions were observed at the application site.

No signs of abnormalities were noted at necropsy.

Justification for classification or non-classification

Based on the available studies, the test substance is not classified for acute toxicity according to EC Regulation No. 1272/2008.