3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Well-documented non-GLP study performed according to a method similar to OECD TG 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Appraisal of the safety of chemicals in foods, drugs and cosmetics; by the Staff of the Division of Pharmacology, FDA, 1959

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide

EC Number:

939-581-9

Cas Number:

1471314-81-4

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Name of test material (as cited in study report): Aminoxid WS 35
- Substance type: light-yellow, clear watery liquid
- Physical state: liquid
- Other: pH 5.0

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 160-205 g
- Fasting period before study: 16h prior to dosage
- Housing: in groups of 5 rats in plastic cages (42x26x14 cm) on wood chips bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Substance was administered in a 100% concentration at dosage levels of 3.98, 5.00, 6.30 and 7.94 ml/kg bw.

Doses:

3.98, 5.00, 6.30 and 7.94 ml/kg.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosage, and at least once daily thereafter.
- Necropsy of survivors performed: yes

Statistics:

Mortality data by Probit-analysis

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6.24 mL/kg bw

Based on:

test mat.

95% CL:

> 5.84 - < 6.65

Mortality:

After 14 days: 0/10 died at 3.98 ml/kg; 2/10 animals died at 5 ml/kg; 6/10 died at 6.30 ml/kg; 8/10 died at 7.94 ml/kg.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

No effects.

Gross pathology:

Animals that died during the study showed slight redness of the gastro-intestinal mucous membrane and the intestine was filled with liquid.
Surviving animals did not show adverse effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral rat LD50 derived after acute exposure and a 14-day recovery period, was 6.24 ml/kg bw. Assuming a relative density of 1, the oral LD50 equals 6240 mg/kg bw. When correcting for the active content (i.e. 35%) the LD50 is 2184 mg/kg bw , which is above the classification limits of the CLP Regulation.