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EC number: 236-195-6 | CAS number: 13223-03-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA guidelines
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): DADM
- Molecular formula (if other than submission substance): C8H16N.Cl
- Molecular weight (if other than submission substance): 161.68
- Smiles notation (if other than submission substance): C(=C)CN{+}(c)(c)(.Cl{-})CC=C
- InChl (if other than submission substance): InChI = InChI=1/C8H16N.ClH/c1-5-7-9(3,4)8-6-2;/h5-6H,1-2,7-8H2,3-4H3;1H/q+1;/p-1
- Substance type: organic
- Physical state: liquid
- Analytical purity: unknown
- Impurities (identity and concentrations): unknown
- Composition of test material, percentage of components: 60% in aqueous solution
- Purity test date:
- Lot/batch No.: S11719-140
- Expiration date of the lot/batch: unknown
- Stability under test conditions: stable
- Storage condition of test material: unknown
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Laboratories, Cumberland, VA, USA
- Age at study initiation: average of 3 to 4 months
- Weight at study initiation:
- Fasting period before study: no
- Housing: individual stainless-steel suspended cages with wire floors.
- Diet: 350 g/day of Respond 2000
- Water: ad libitum
- Acclimation period: yes (quarantine of unknown duration)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2±1.2
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: 22/12/1975 To: 23/03/1976
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): daily
- Mixing appropriate amounts with: Respond 2000 dog chow
- Storage temperature of food: unknown
VEHICLE
- Justification for use and choice of vehicle: none - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Diets were adjusted to deliver specified doses of monomer in a 350 gram meal.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 200, 800 mg/kg bw/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 4 per sex per dose
- Control animals:
- yes, plain diet
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Prior to initial feeding, at 45 days and at end of study.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: All animals
- Parameters checked in tables 7-13 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Prior to initial feeding, at 45 days and at end of study.
- Animals fasted: No data
- How many animals: All animals
- Parameters checked in table 14-19 were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: Prior to initial feeding, at 45 days and at end of study.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in tables20-25 were examined.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- All dogs were necropsied and histopathology performed.
Internal organs were carefully inspected and representative blocks from the following ones were saved: skin, eyes, ears, tongue, fat, skeletal muscle, salivary glands, thyroids*, trachea, esophagus, lungs, heart*, gallbladder, liver*, stomach, small intestine, large intestine, adrenals*, kidneys*, urinary bladder, gonads*, prostate, vagina, pituitary*, brain*, spinal cord, bone and marrow. The asterisked tissues were also weighted and organ-to-body weight as well as organ-to-brain weight ratios were calculated.
Representative sections from the above organs and tissues from all dogs were stained with routine hematoxylin and eosin and examined with ordinary light microscopy.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- only at highest dose
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- 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
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
BODY WEIGHT AND WEIGHT GAIN
The terminal body weights of the 800 mg/kg male dogs were significantly lower than the terminal body weights of the control group. Otherwise there were no treatment related effects in this study.
FOOD CONSUMPTION AND COMPOUND INTAKE
Only an occasional test group had a significantly different average daily feed consumption as compared to the control.
FOOD EFFICIENCY
- The mean feed efficiency of the control group ranged from 0.047 to 0.257 with an average feed efficiency of 0.142. The corresponding mean weekly body weight gain ranged from 0 to 600 g. over the duration of the experiment with a net average gain of 4,100 g.
- The mean feed efficiency for the 50 mg/kg DADMAC group ranged from o to 0.217, with an average feed efficiency of 0.107. The corresponding mean weekly body weight gain ranged from 0 to 500 g with a net average weight gain of 3,300 g.
-The mean feed efficiency for the 200 mg/kg DADMAC group ranged from o to 0.258, with an average feed efficiency of 0.130. The corresponding mean weekly body weight gain ranged from 0 to 600 g. with a net average weight gain of 3,900 g.
- The mean feed efficiency for the 800 mg/kg DADMAC test group ranged from 0.045 to 0.275 with an average feed efficiency of 0.121. The corresponding mean weekly body weight gain ranged from 100 to 500 g with a net average weight gain of 3.200 g.
HAEMATOLOGY
- The lowest hematocrit at 0 weeks was 33% in one control dog.
- The lowest haemoglobin at 0 weeks was 10.8 gms% (in one control dog and one 800 mg/kg dog ). By three months all dogs had normal haemoglobin values.
- White cell differential counts of all dogs, both male and female, remained within normal limits for the duration of the study.
CLINICAL CHEMISTRY
- Although some of dogs at 0 week had a blood glucose concentration between 129 and 150 mg%, at six and 13 weeks all blood glucose values fell within normal limits.
All BUN, SGOT, SGPT, and CGTP values were within the normal values at termination of the study.
URINALYSIS
All dogs except one had normal urinalysis findings at the beginning, at 45 days and at the conclusion of the experiment. One Dog (800 mg/kg group) at six weeks had 8-10 RBC/h.p.f. By thirteen weeks, however, its urinalysis results were normal.
ORGAN WEIGHTS
The mean terminal body weight for the male control group was 9.0 kg, for the 50 mg/kg group, 8.1 kg., for the 200 mg/kg group, 8.5 kg and for the 800 mg/kg group 7.8 kg. The corresponding mean terminal body weight for the female control group was 8.1 kg., for the 50 mg/kg group, 7.9 kg., for the 200 mg/kg group 8.6 kg and for the 800 mg/kg group, 7.8 kg.
The mean thyroid weight for the male control group was 0.70 gram, for the 50 mg/kg test group 0.78 gram, for the 200 mg/kg group 0.71 gram and for the 800 mg/kg group 0.78 gram. The corresponding mean thyroid weight for the female control group was 0.71 gram, for the 50 mg/kg group 0.81 gram, for the 200 mg/kg group 0.64 gram and for the 800 mg/kg group 0.78 gram
The mean heart weight for the male control group was 72.50 grams, for the 50 mg/kg group 66.30 grams, for the 200 mg/kg group 68.80 grams and for the 800 mg/kg group 57.50. The corresponding mean heart weight for the female control group was 63.80 grams, for the 50 mg/kg group 65.00 grams, for the 200 mg/kg group 63.80 grams and for the 800 mg/kg group 72.50 grams
The mean liver weight for the male control group was 231.3 grams, for the 50 mg/kg group 208.8 grams, for the 200 mg/kg group 265.0 grams and for the 800 mg/kg group 252.5 grams. The corresponding liver weight for the female control group was 202.5 grams, for the 50 mg/kg group 218.8 grams, for the 200 mg/kg group 212.5 grams and for the 800 mg/kg group 221.3 grams.
The mean adrenal weight for the male control group was 0.85 gram, for the 50 mg/kg group 0.95 gram, for the 200 mg/kg group 0.94 gram and for the 800 mg/kg group 0.93 gram. The corresponding mean adrenal weight for the female control group was 0.80 gram, for the 50 mg/kg group 0.92 gram, for the 200 mg/kg group 0.85 gram and for the 800 mg/kg group 0.95 gram.
The mean kidney weight for the male control group was 50.00 grams, for the 50 mg/kg group 45.00 grams, for the 200 mg/kg group 55.00 grams and for the 800 mg/kg group 50.00 grams. The corresponding mean kidney weight for the female control group was 40.00 grams, for the 50 mg/kg group 43.80 grams, for the 200 mg/kg group 41.30 grams and for the 800 mg/kg group 45.00.
The mean testicular weight for the male control group was 6.55 grams, for the 50 mg/kg group 6.94 grams, for the 200 mg/kg group 4.48 grams and for the 800 mg/kg DADM group 8.02 grams. The corresponding ovarian weight for the female control group was 0.69 gram, for the 50 mg/kg group 0.75 gram, for the 200 mg/kg DADM group 0.56 gram and for the 800 mg/kg DADM group 0.80 gram.
The mean pituitary weight for the male control group was 0.07 gram, for the 50 mg/kg group 0.06 gram, for the 200 mg/kg group 0.07 gram and for the 800 mg/kg group 0.01 gram The corresponding pituitary weight for the female control group was 0.06 gram, for the 50 mg/kg group 0.06 gram, for the 200 mg/kg DADM group 0.05 gram and for the 800 mg/kg group 0.06 gram.
The mean brain weight for the male control group was 72.00 grams, for the 50 mg/kg group 76.30 grams, for the 200 mg/kg group 76.00 grams and for the 800 mg/kg group 79.00. The corresponding brain weight for the female control group was 69.30 grams, for the 50 mg/kg DADM group 71.30 grams, for the 200 mg/kg DADM group 73.50 grams and for the 800 mg/kg DADM group 73.80 grams.
HISTOPATHOLOGY: NON-NEOPLASTIC
Two male dogs (one of the 50 mg/kg group and one of the 200 mg/kg group) had small testes macroscopically. Microscopically the seminiferous tubules appeared underdeveloped . It was not believed to be compound-related but rather of congenital origin. One additional dog (of the 200 mg/kg group) had small pulmonary granulomata compatible with pulmonary ascariasis but neither larva could be demonstrated in the granulomata nor worms in the intestine. All remaining dogs had normal histology.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- LOAEL
- Effect level:
- 800 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: decrease in body weight gain.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for DADMAC was 200 mg/kg/day and the LOAEL was 800 mg/kg/day (based on body weight loss). These values are valid for the registered substance based on their close structural relationship.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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