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EC number: 276-309-1 | CAS number: 72058-41-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June 2018 - 14 Aug 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine
- EC Number:
- 276-309-1
- EC Name:
- 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine
- Cas Number:
- 72058-41-4
- Molecular formula:
- C11H18Cl2N4
- IUPAC Name:
- 4,6-dichloro-N-(2,4,4-trimethylpentan-2-yl)-1,3,5-triazin-2-amine
- Test material form:
- solid
- Details on test material:
- Colour: light yellow
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SUQIAN UNITECH CO., LTD; 2018041002
- Purity: 99.29%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was weighed out into a tared plastic vial on a precision balance and finely ground with the help of a mortar and pestle. The test item was then suspended with the vehicle corn oil to gain a final volume of 10 mL and to achieve a dose of 2000mg/kg body weight at a dose volume of 10 mL/kg body weight. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.
Test animals
- Species:
- rat
- Strain:
- other: WISTAR Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 8–10 weeks
- Weight at study initiation: Step 1: 173–181 g;Step 2: 178–183 g
- Fasting period before study: 16 to 19 hours
- Housing: Full barrier in an air-conditioned room
- Diet: Free access to Altromin 1324 maintenance diet for rats and mice
- Water: Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The test item does not make a solution or suspension with water, so the corn oil has to be used.
- Lot/batch no. (if required): MKCD1821
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose level of 2000 mg/kg bw was used as the starting dose, according to the test guideline, No compound-related mortality was recorded for any other animals of step 1 or 2. - Doses:
- Steps 1 & 2: 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 500 mg/kg bw
- Mortality:
- For one animal (-Step 1, Animal No.1) compound-related mortality occurred. No compound-related mortality was recorded for any other animals of step 1 or 2.
- Clinical signs:
- other: The most relevant clinical findings were reduced spontaneous activity, hunched posture, piloerection, eyes half closed, diarrhoea and slight weight loss during the first study week. All animals recovered within up to 8 days post-dose (Table 1).
- Gross pathology:
- Detailed pathological findings of the study are presented in Table 3.
No specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Table 1: Clinical Signs - Individual Data
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Time Point | Observations |
1 |
1 / Female | 2000 | 0 min – 30 min | nsf |
30 min – 120 min | Hunched posture, | |||
slight piloerection | ||||
120 min – d 2 | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea | |||
d 2 | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, slight diarrhoea, | |||
slight weight loss (2%) | ||||
d 3 | found dead | |||
2 / Female | 2000 | 0 min – 30 min | nsf | |
30 min – 120 min | Hunched posture, | |||
slight piloerection | ||||
120 min – d 2 | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea | |||
d 2 – d 3 | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea, slight weight loss | |||
(3% by d 3) | ||||
d 4 | Moderately reduced spontaneous activity, hunched posture, moderate piloerection | |||
d 5 – d 8 | Slight piloerection | |||
d 9 – d 15 | nsf | |||
3 / Female | 2000 | 0 min – 30 min | nsf | |
30 min – 120 min | Hunched posture, | |||
slight piloerection | ||||
120 min – d 2 | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, diarrhoea moderate | |||
d 2 | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea, slight weight loss (<1%) | |||
d 3 | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, slight diarrhoea | |||
d 4 | Moderately reduced spontaneous activity, hunched posture, | |||
moderate piloerection | ||||
d 5 | Slight piloerection | |||
d 6 | Moderate piloerection | |||
d 7 – d 8 | Slight piloerection | |||
d 9 – d 15 | nsf | |||
2 |
4 / Female | 2000 | 0 min – 30 min | nsf |
30 min – 60 min | Slight piloerection | |||
60 min – 120 min | Slightly reduced spontaneous activity, hunched posture, | |||
slight piloerection | ||||
120 min – 180 min | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea | |||
180 min – 240 min | Spontaneous activity moderately reduced, hunched posture, moderate piloerection, | |||
moderate diarrhoea | ||||
240 min – d 2 | Spontaneous activity moderately reduced, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea | |||
d 2 | Slight piloerection, severe diarrhoea, slight weight loss (1%) | |||
d 3 | Slight diarrhoea | |||
d 4 – d 15 | nsf | |||
5 / Female | 2000 | 0 min – 30 min | nsf | |
30 min – 60 min | Slight piloerection | |||
60 min – 120 min | Slightly reduced spontaneous activity, hunched posture, | |||
slight piloerection | ||||
120 min – 180 min | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea | |||
180 min – 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, | |||
moderate diarrhoea | ||||
240 min – d 2 | Moderately reduced spontaneous activity, hunched posture, severe piloerection, half eyelid-closure, moderate diarrhoea | |||
d 2 | Slight piloerection, severe diarrhoea, slight weight loss (7%) | |||
d 3 | Slight diarrhoea | |||
d 4 – d 15 | nsf | |||
6 / Female | 2000 | 0 min – 30 min | nsf | |
30 min – 60 min | Slight piloerection | |||
60 min – 120 min | Spontaneous activity slightly reduced, hunched posture, | |||
slight piloerection | ||||
120 min – 180 min | Slightly reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, diarrhoea moderate | |||
180 min – 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, | |||
moderate diarrhoea | ||||
240 min – d 2 | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea | |||
d 2 | Slight piloerection, | |||
severe diarrhoea | ||||
d 3 | Slight diarrhoea | |||
d 4 – d 15 | nsf |
bw = body weight; d = day (day 1 = day of administration); min = minute(s); nsf = no specific findings
Table 2:Absolute Body Weights in g and Body Weight Change in %
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | BW (g) | Body Weight Change in Comparison to Day 1 (%) | ||
Day 1 | Day 8 | Day 15 | Day 15 | |||
1 | 1 / Female | 2000 | 181 | Found dead on study day 3 | ||
2 / Female | 2000 | 175 | 194 | 225 | 29 | |
3 / Female | 2000 | 173 | 205 | 208 | 20 | |
2 | 4 / Female | 2000 | 183 | 196 | 203 | 11 |
5 / Female | 2000 | 179 | 177 | 197 | 10 | |
6 / Female | 2000 | 178 | 184 | 210 | 18 |
bw= body weight
Table 3:Findings of the Necropsy - Individual Data
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Organ | Macroscopic Findings |
1 | 1 / Female | 2000 | - | nsf |
2 / Female | - | nsf | ||
3 / Female | - | nsf | ||
2 | 4 / Female | - | nsf | |
5 / Female | - | nsf | ||
6 / Female | - | nsf |
bw = body weight;nsf = no specific findings
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Not classified according to CLP
- Conclusions:
- The median lethal dose of 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 2500 mg/ kg bw
- Executive summary:
In an acute oral toxicity test (183811), 2 groups of female Wistar Crl: WI(Han) rats (3/group) were administered 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine (99.29%) in corn oil by oral gavage at a dose of 2000 mg/kg bw.
The LD50 (cut-off) was 2500 mg/kg bw.
One animal of step 1 was found dead 2 days post-application. All remaining animals survived until the end of the study showing signs of toxicity. The most relevant clinical findings were reduced spontaneous activity, hunched posture, piloerection, eyes half closed, diarrhoea and slight weight loss during the first study week. All animals recovered within up to 8 days post-dose. Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
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