Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is very similar to a standard guideline study. However it was conducted prior to OECD guideline and GLP. No analysis of test substance in diet was conducted. There was no statistical analysis of the results. Full details of the study are not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

No ophthalmological examination and no functional observations. Limited haematology, clinical chemistry and pathology.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

EC Number:

234-204-8

EC Name:

Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

Cas Number:

10595-49-0

Molecular formula:

C19H42N2O5S

IUPAC Name:

3-(dodecanoylamino)-N,N,N-trimethylpropan-1-aminium methyl sulfate

Details on test material:

- Name of test material (as cited in study report): Catanac (LS)

Test animals

Species:

rat

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Carworth Farms, Rockland, NY
- Weight at study initiation: Average body weight for both sexes of 42g
- Housing: Individual cages
- Water (e.g. ad libitum): Ad libidum

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 73
- Humidity (%): 40-60
- Air changes (per hr): 10

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Wayne Lab-Blox of Allied Mills Inc, Chicago, Illinois

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

90 days

Frequency of treatment:

Continuosly in diet

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

3 000 ppm

Doses / concentrations 2

Dose / conc.:

1 500 ppm

Doses / concentrations 3

Dose / conc.:

750 ppm

No. of animals per sex per dose:

20 males and 20 females

Control animals:

yes, plain diet

Positive control:

No

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule for examinations: Daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule for examinations: Weekly

BODY WEIGHT: Yes
- Time schedule for examinations: Weekly

FOOD CONSUMPTION: Yes
- Time schedule for examinations: Weekly

FOOD EFFICIENCY: No

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: 45 and 90 days
- How many animals: 5 males and 5 females
- Parameters examined: Haematocrit %, total haemoglobin concentration, total and differential leukocyte counts, RBC morphology

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 45 and 90 days
- How many animals: 5 males and 5 females
- Parameters examined: urea nitrogen, alkaline phosphatase, glutamic oxaloacetic transaminase, fasting glucose

URINALYSIS: Yes
- Time schedule for collection of urine: 45 and 90 days
- Parameters examined: pH, specific gravity, glucose, protein, haemoglobin, presence of cells, casts and crystals

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:

ORGAN WEIGHTS: Yes - thyroids, liver, kidneys, adrenals, testes
GROSS PATHOLOGY: Yes - skin, eyes, ears, mouth, fat, skeletal muscle, bone and marrow, salivary glands, thyroid, trachea, oesophagus, lung, heart, aorta, thymus, spleen, lymph nodes, pancreas, liver, stomach, small intestine, large intestine, caecum, adrenals, kidneys, urinary bladder, ovaries, testes, vagina, pituitary and brain
HISTOPATHOLOGY: Yes - skin, fat, skeletal muscle, bone and marrow, thyroid, parathyroid, trachea, oesophagus, lung, heart, aorta, spleen, pancreas, liver, stomach, small intestine, large intestine, adrenals, kidneys, urinary bladder, ovaries, testes, vagina, pituitary and brain

Statistics:

Not reported

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Details on results:

There were no treatment related effects reported.

Effect levels

Key result

Dose descriptor:

NOEL

Effect level:

3 000 ppm

Based on:

act. ingr.

Sex:

male/female

Basis for effect level:

body weight and weight gain

food consumption and compound intake

Target system / organ toxicity

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

There were no treatment related effects following dietary dosing of the substance for 90 days to rats. Therefore the NOEL is 3000 ppm (calculated to be approximately equivalent to 279 mg/kg for males and 293 mg/kg for females).