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EC number: 239-269-6 | CAS number: 15217-42-2
- 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
Endpoint summary
Administrative data
Description of key information
Read across from two studies (one sub-acute, one chronic) for the oral route,
one 14 day Range-finding study available supporting the Read across.
The selected NOAEL of 150 mg/kg bw/day is observed in the sub-acute study for the analogue Tolyltriazole.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: mean: 89 g (male) 86 g (female)
- Fasting period before study: no
- Housing: standard Makrolon-cages type II
- Diet: Altromin 1324 Pellets, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: the test item was grounded and solved in the vehicle
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water): the test item is soluble and stable in the vehicle which is commonly used
- Concentration in vehicle: 10 to 90 mg / ml
- Amount of vehicle (if gavage): 5 ml / kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of the test item in the vehicle was determined and no significant changes of the composition was observed after 48 hours.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
50 mg/kg
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
150 mg/kg
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
450 mg/kg
Basis:
actual ingested - No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: the doses were selected based on a range finding study
- Positive control:
- No
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once or twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
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
HAEMATOLOGY: Yes
- Time schedule for collection of blood: only at end of study
- Animals fasted: Yes
- How many animals: all
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: only at end of study
- Animals fasted: Yes
- How many animals: all
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- arithmetic means and standard deviation
for organ weights the confidence levels 95 and 99 %
Comparision of test and control group results are done with test of significance (U-test) with a= 5 % and a = 1% - 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:
- effects observed, treatment-related
- Description (incidence and severity):
- in 450 mg/kg bw groups
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- 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:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
one animal (450 mg/kg bw, female) died during the study
after the daily application, all animals in the dose group of 450 mg/kg bw showed apathy
BODY WEIGHT AND WEIGHT GAIN
no findings
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
no findings
HAEMATOLOGY
no findings in the dose groups 50 and 150 mg/kg bw
reduced levels of eryhtocytes, hematocrit and hemoglobine in the male dose group 450 mg/kg bw
CLINICAL CHEMISTRY
Raised activity of alanin-aminotransferase in male/female dose group 450 mg/kg bw
Reduced concentration of the plasma protein concentration in male/female dose group 450 mg/kg bw
ORGAN WEIGHTS
no findings
GROSS PATHOLOGY
two male and one female animal had pale kidneys
HISTOPATHOLOGY: NON-NEOPLASTIC
no findings
OTHER FINDINGS - Dose descriptor:
- NOAEL
- Effect level:
- ca. 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Critical effects observed:
- not specified
- Conclusions:
- Benzotriazole has a NOAEL of 150 mg/kg bw for the 28 days repeated dose toxicity.
- Executive summary:
For Tolyltriazole a well-conducted in vivo study is available showing a NOAEL of 150 mg/kg bw for the 28 days repeated dose toxicity. This means that a similar result for Sodium Benzotriazolate can be anticipated.
Sodium Benzotriazolate has a NOAEL of 150 mg/kg bw for the 28 days repeated dose toxicity.
A DNEL for oral, dermal and/or inhalation route can be based on this information.
Classification and labeling are / are not needed for this endpoint.
A risk characterisation will be performed because the substance is classified for oral toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Two studies from analogues (Benzotriazole and Tolyltriazole) available.
A 14-day Range-finding study for the substance is available and supports the selection (A LOEL of 183.6 mg/kg bw/day was derived).
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No study for sub-acute or sub-chronic repeated dose toxicity available for this substance.
The sub-acute study of the analogue Tolyltriazole is selected as it provides the most sensitive NOAEL
Justification for classification or non-classification
The information on repeated dose toxicity are conclusive but not sufficient for a classification according Regulation (EC) No. 1272/2008.
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.
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