Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
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

Test material

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

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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

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 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.