Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 18-JAN-2018 to 22-MAR-2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17th December 2001
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:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
- Fasting period before study: food but not water were withheld over-night
- Housing: plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning
- Diet: laboratory food ssniff (Spezialdiäten GmbH, Germany) at recommended doses
- Water: tap water for human consumption, ad libitum
- Acclimation period: 5 days prior to the start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.8 ± 0.5° C
- Humidity (%): 54.0 ± 2.0 %
- Air changes (per hr): not stated
- Photoperiod: 12-hour light /12-hour dark cycle

IN-LIFE DATES: From 30 January 2018 To: 14 February 2018

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: /
- Amount of vehicle (if gavage): /
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no. (if required): L63417

MAXIMUM DOSE VOLUME APPLIED: /

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: available information (from a similar substance) indicated that the test item is likely to be non-toxic with regard to acute
toxicity.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2x3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately after administration of the test item and 0.5, 1, 2, and 4 hours later, and daily for the next 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: individual weights of animals were measured immediately prior to test item administration and weekly thereafter.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All (6/6 females) animals survived.
Clinical signs:
none
Body weight:
The body weight of animals increased between week 1 and week 2, except 2 animals (stagnation of body weight in one female and decrease of body weight in another female)
Gross pathology:
No macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of triisononylamine is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Executive summary:

The test item Triisononylamine was administered to 6 females Wistar rats at a limit dose of 2000 mg/kg (OECD 423, GLP). The limit dose did not cause death or evident signs of toxicity. During the follow up period, no other signs of intoxication, change of health, nor any other adverse reactions were displayed. The body weight of animals increased between week 1 and week, 2 except 2 animals.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

The LD50 of triisononylamine is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.