Tris(2-hydroxyethyl)ammonium salts of tall-oil fatty acids

Endpoint summary

Description of key information

Oral rat: LD50 > 2000 mg/kg bw  (no mortality at 2000 mg/kg bw)

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

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

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS: rats, Wistar Crl:(WI) BR (outbred, SPF-Quality)
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: ca. 7 weeks
- Housing: group housing of 3 animals per sex per cage (Macrolon cages, type IV)
- Fasting period before study: up to 20h prior to dosing, 3-4h after administration of the test material
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: the vehicle was tested in a pre-test.

Doses:

single dose: 2000 mg/kg bw

No. of animals per sex per dose:

3 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily (mortality//viability), at periodic intervals on Day 1 (administration) and thereafter once daily until Day 15 (clinical signs)
- Frequency of weighing: Days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

not performed

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: Lethargy, hunched posture, uncoordinated movements and/or piloerection were noted among the females on Day 1. No clinical signs of systemic toxicity were noted in males.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Interpretation of results:

other: no acute lethal toxicity

Conclusions:

Based on the results and according to the EU REGULATION (EC) 1272/2008 the substance does not have to be classified for oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral rat: LD50 > 2000 mg/kg bw (no mortality at 2000 mg/kg bw). Acute dermal rat: Waiving, as this study was considered to be scientifically unjustified. Acute inhalation rat: Waiving, as this study was considered to be scientifically unjustified. Exposure to WS400102 by the inhalation route is unlikely, because of its low vapour pressure and because it is a highly viscous liquid.

Justification for classification or non-classification

In the acute oral toxicity study in rats no death occurred at the highest dose of 2000 mg/kg bw. Systemic exposure to WS400102 after dermal or inhalation exposure will be much lower than after oral exposure and therefore no higher toxicity is to be expected via these exposure routes. No requirement of classification for acute oral, dermal or inhalation toxicity [Regulation (EC) 1272/2008].