Registration Dossier
Registration Dossier
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EC number: 254-104-8 | CAS number: 38725-13-2
Acute Toxicity: oral
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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Triisononylamine
- EC Number:
- 254-104-8
- EC Name:
- Triisononylamine
- Cas Number:
- 38725-13-2
- Molecular formula:
- C27H57N
- IUPAC Name:
- tris(7-methyloctyl)amine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system 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.
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