Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Triisooctylamine
EC Number:
247-092-0
EC Name:
Triisooctylamine
Cas Number:
25549-16-0
Molecular formula:
C24H51N
IUPAC Name:
tris(6-methylheptyl)amine
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.: 0008924462

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: female animals approx. 10 weeks
- Weight at study initiation: animals of comparable size and weight
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 3
- Humidity (%): 30 – 70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: unchanged (no vehicle) or corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: only for 300 mg/kg: 15 g/100 mL
- Amount of vehicle (if gavage): 2 mL/kg bw
- Justification for choice of vehicle: corn oil was a suitable vehicle

MAXIMUM DOSE VOLUME APPLIED: 2.47 mL/kg bw (undiluted) or 2 mL/kg (300 mg/kg)
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
3 females at 2000 mg/kg and 6 females at 300 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animals was made at least once each workday. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. Individual body weights shortly before administration (day 0), weekly thereafter and on the day of death or sacrifice moribund starting with study day 6.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations. Necropsy of all animals that died as early as possible after death.
Statistics:
N/A

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal of the 2000 mg/kg bw test group was found dead on study day 6 (delayed mortality), while the two remaining animals were sacrificed in a moribund state on the same day. No mortality occurred in both 300 mg/kg bw test groups.
Clinical signs:
other: In the animal of the 2000 mg/kg bw test group that was found dead on study day 6 impaired general state and piloerection were observed from study day 1 until study day 3, while exsiccosis and body weight reduction were noted from study day 2 until study d
Gross pathology:
Due toe the advanced putrefaction no macroscopic pathological findings could be determined in the animal that was found dead on study day 6. In the animals which were sacrificed in a moribund state on study day 6 no macroscopic pathological findings were observed. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (300 mg/kg bw: 6 females).

Any other information on results incl. tables

Under the conditions of this study the median lethal dose of Triisooctylamine after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria