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

Acute Toxicity: oral

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:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

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

Test material information

Constituent 1

Test material form:

other: semi-solid, wax-like (at 20°C)

Test animals

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

Administration / exposure

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

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:

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.

Applicant's summary and conclusion

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.