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Toxicological information

Repeated dose toxicity: oral

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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:
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

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
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 / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
3000 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
1500 ppm
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
750 ppm
Basis:
nominal in diet
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

Dose descriptor:
NOEL
Effect level:
3 000 ppm
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
body weight and weight gain
clinical biochemistry
clinical signs
food consumption and compound intake
gross pathology
haematology
histopathology: neoplastic
histopathology: non-neoplastic
ophthalmological examination
organ weights and organ / body weight ratios
urinalysis
water consumption and compound intake

Target system / organ toxicity

Critical effects observed:
not specified

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).