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EC number: 249-596-6 | CAS number: 29385-43-1
- 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
One orale subaute toxicity study is available, giving a NOAEL of 150 mg/kg bw/day.
As the former read-across to the proposed analogueous substance Benzotriazole (CAS 95-14-7) proofed to be
scientifcly not adequate, a read-across based on a category developed in OECD QSAR Toolbox
was used to fulfill the data gap which arose.
Category read-across Predictions taking into account studies with durations > 28 d
resulted in dose descriptors for the two main constituents.
While 4-Methyl-1H-Benzotriazole was predicted to have a NOAEL/NOEL of 435 resp. 168 mg/kg bw/day,
the results for 5-Methyl-1H-Benzotriazole are more consistent:
Ttwo predictions were made, one included substances for which a NOEL is available and one prediction
with substances with a NOAEL.
Both predictions resulted in a NOEL/NOAEL for 5-Methyl-1H-Benzotriazole (repeated dose toxicita, duration > 28 d) of
19 mg/kg bw/day.
However this information cannot be used for Hazard conclusion, as the approach does not give information on target organ(s) and
details of effects.
As a test is proposed, the information from this read across approach could be used for dose selection.
In a prenatal developmental toxicity study, a NOAEL of 90 mg/kg bw/day for systemic toxicity was determined.
For Hazard and risk assessment the lowest dose descriptor available is used.
A recalculation from the constituent to the substance, taking into account the typical concentration of the constituent
is not performed.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD-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 gounded 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 - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- haematology
- Critical effects observed:
- not specified
- Conclusions:
- In doses up to 150 mg/kg bw / day, no adverse effects were observed.
A dose of 450 mg/ kg bw/day lead to apathy after gavage, to a changed blood count and raised plasma activity of transaminases GOT and GPT
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:
- The study is a well conducted GLP-Study following the OECD-Guideline
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
Mode of Action Analysis / Human Relevance Framework
based on the available data, no mode of action can be identified.
Additional information
Justification for classification or non-classification
Based on the available data and the low severity of effects observed in experimental studies, criteria for classification is not met.
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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