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

Endpoint summary

Description of key information

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.

 

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

Study period:

1999-01-10 to 1999-01-28

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)

Version / remarks:

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

Deviations:

no

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

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

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.

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

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.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

EU Method B.1/OECD Guideline 423 (RL1)

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral

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.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute oral toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) No 2019/521.