Reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and lithium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-01-10 to 1999-01-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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)

Version / remarks:

96/54 EWG B.1.tris (Akute-toxische-Directive 96/54 EEC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 22. March 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Starin: HsdBrl:WH,Full-Barrier
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: Female 150 - 162 g; male 146 - 153 g
- Fasting period before study: Animals were fasted by withholding food over-night. Following the period of fasting the animals were weighed and the test substance was administered. Then the food was withhold for a further 3-4 hours.
- Housing: Individually kept in Macrolon cages on Altromin saw fiber bedding
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free-TPF
- Water: ad libitum, tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3° C
- Humidity: 55 ± 10%
- Air changes: 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.00 - 18.00

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

Carboxymethylcellulose (1 % in aqua dest.)

Details on oral exposure:

VEHICLE
- Amount of vehicle: Carboxymethylcellulose; 1% in aqua bidest.
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males/3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed prior to first application and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, cageside observations, respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern, observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

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 occurred during the study.

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period.

Gross pathology:

Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test material (EC: 433-100-1) in the Wistar rat (HsdBrl strain) was found to be greater than 2000 mg/kg bw.

Executive summary:

The test substance (EC: 433-100-1) was tested for acute toxicity on oral administration in rats in a study according to EU Method B.1/OECD Guideline 423. A single dose of 2000 mg/kg bw was administered by oral gavage to 3 male and 3 female Wistar rats. The animals were observed for fourteen days for signs of toxicity. No signs of mortality or systemic toxicity were noted during the study. All animals showed an expected gain in body weight during the study. No abnormalities were noted at necropsy.

Therefore, the acute oral median lethal dose (LD50) of the test substance (EC: 433-100-1) was found to be greater than 2000 mg/kg bw.