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EC number: 404-450-2 | CAS number: 118685-34-0 COBRATEC 435
- 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:
- 11.08.1988 - 01.09.1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- Sodium 5-N-butylbenzotriazole
- EC Number:
- 404-450-2
- EC Name:
- Sodium 5-N-butylbenzotriazole
- Cas Number:
- 118685-34-0
- Molecular formula:
- CCCCc1ccc2c(c1)nnn2[Na]
- IUPAC Name:
- sodium 5-butyl-1H-1,2,3-benzotriazol-1-ide
- Test material form:
- solid - liquid: suspension
- Remarks:
- 37% aqueous solution
- Details on test material:
- Identification: Butyl benzotriazole-sodium salt (37% solution)
Physical state: Brown liquid
Purity: 37% aqueous solution
Storage: Ambient conditions of humidity and temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Equal numbers of male and female CFY (Sprague-Dawley origin) rats were obtained from Interfauna U.K. Ltd., Huntingdon, Cambridgeshire, England. They were in a weight range of 98 to 150 g prior to dosing (Day 1) in the main study and approximately four to six weeks of age. All the rats Were acclimated to the experimental environment for a period of 8 days prior to the start of the main study.
The rats were allocated to cages within the treatment groups. They were housed in groups of up to five rats of the same sex in metal cages with wire mesh floors.
A standard Iaboratory rodent diet (Labsure LAD 1) and domestic quality potable water were provided ad libitum. Access to food only was prevented overnnight prior to and approximately 4 hours after dosing.
The mean daily minimum and maximum temperatures of the animal room were 22°C and 23°C respectively and the mean daily relative humidity value was 68% R.H. The rate of air exchange was maintained at approximately 15 air changes/hour. Lighting was controlled by means of a time switch to provide 12 hours artificial lÍght in each 24-hours period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter (8 choke)
- Doses:
- Preliminary test: 0.80 and 2.50 g a.i./kg
Main study: 0.80, 1.26 and 2.00 g a.i./kg - No. of animals per sex per dose:
- Preliminary test: 2 males and 2 females per dose
Main study: 5 males and 5 females per dose - Control animals:
- no
Results and discussion
- Preliminary study:
- Mortality data for group of rats dosed orally with butyl benzotriazole-sodium salt (37% solution)
Dose (g a.i./kg) Mortality ratio (No; of deaths/No. dosed) Time of death after dosing
0.80; Male: 0/2; Female: 1/2; Combined: 1/4 ; Day 3
2.50; Male: 2/2; Female: 2/2; Combined: 4/4 ; < 4 h - < 22 h
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 400 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 1 100 - <= 1 900
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 400 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 1 000 - <= 2 400
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 300 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 900 - <= 2 100
- Mortality:
- There was a single male death amongst rats dosed at 0.80 g a.i/kg and deaths amongst both sexes of rat treated at 1.26 g a.i./kg and above. The majority of rats died from within six hours of dosing until Day 4. A single male, treated at the low dose Ievel, was found dead on Day 10.
Autopsy of rats that died commonly revealed no macroscopic abnormalities. The only exception was the presence of brown Iiquid within the urinary bladder of a single male dosed at 2.00 g a.i./kg. - Clinical signs:
- other: Common signs of reaction to treatment within four hours of dosing were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), Iethargy, decreased respiratory rate, ptosis, pallor of the extremities, increased salivation and pro
- Gross pathology:
- Autopsy of rats that died commonly revealed no macroscopic abnormalities. The only exception was the presence of brown Iiquid within the urinary bladder of a single male dosed at 2.00 g a.i./kg.
- Other findings:
- Terminal autopsy findings were normal.
Any other information on results incl. tables
Mortality data for groups of rats dosed orally with butyl benzotriazole-sodium salt (37% solution)
Main Study
|
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute median lethal oral doses (LD50) and their 95% confidence limits to rats of butyl benzotriazole-sodium salt,dosed as a 37% solution,were estimated to be:
Males and females combined: 1.4 (1.1 to 1.9) g a.i./kg bodyweight.
Males only: 1.4 (1.0 to 2.4) g a.i./kg bodyweight.
Females only: 1.3 (0.9 to 2.1) g a.i./kg bodyweight.
The results of this study established that Butyl benzotriazole, sodium salt hac to be classified:
Harmful with the risk phrase R22 (harmful if swallowed), according directive 67/548/EEC (DSD)
Acute Tox. 4 with Hazardous Statement H302 (harmful if swallowed), according regulation (CE) 1272/2008 (CLP) - Executive summary:
A study was performed to assess the acute oral toxicity to rats of Butyl benzotriazole, sodium salt
The study was conducted in accordance wilth under Annex V of the EEC direcetíve 79/831/EEC, Part B Methods for determínation of toxicity, Method B1 Acute OraI Toxicity, and the OECD guideline for Testing of Chemicals No. 401 "Acute OraI Toxicity"
The acute median lethal oral doses (LD50) and their 95% confidence limits to rats of butyl benzotriazole, sodium salt, dosed as a 37% solution,were estimated to be:
Males and females combined: 1.4 (1 .1 to 1.9) g a.i./kg bodyweight.
Males only: 1.4 (1.0 to 2.4) g a.i./kg bodyweight
Females only: 1.3 (0.9 to 2.1) g.a.i./kg bodyweight
Main study shows
Mortality: There was a single male death amongst rats dosed at 0.80 g a.i/kg and deaths amongst both sexes of rat treated at 1.26 g a.i./kg and above. The majority of rats died from within six hours of dosing until Day 4. A single male, treated at the low dose Ievel, was found dead on Day 10.
Autopsy of rats that died commonly revealed no macroscopic abnormalities. The only exception was the presence of brown Iiquid within the urinary bladder of a single male dosed at 2.00 g a.i./kg.
Clinical signs: Common signs of reaction to treatment within four hours of dosing were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), Iethargy, decreased respiratory rate, ptosis, pallor of the extremities, increased salivation and prostration. Other clinical signs apparent at the same time or at later intervals on Day 1 were:
- ataxia amongst rats treated at all dose levels,
- increased lachrymation amongst females dosed at 0.80 g .i./kg and in all rats treated at 1.26 and 2.00 g.a.i/kg.
Recovery of rats surviving treatment, as judged by external appearance and behaviour, was apparently complete by Days 4 and 5 (0.80 and 1.26 g a.i./kg) or Day 7 (2.00 g a.i./kg).
Delayed signs of toxicity including pilo-erection , abnormal body carriage, abnormal gait, lethargy and pallor of the extremities reappeared on Day 9 in one male dosed at 0.80 ga.i./kg and preceded death on the following day.
Bodyweight: Low bodyweight gains during the first week of the study were recorded for all surviving rats.
Single male and female rats dosed at 0.80 and 1.26 g a.i./kg and a further male treated at the high dose level showed low bodyweight, gains between Days 8 and 15.
Terminal autopsy findings were normal
It is concluded that butyl benzotriazol, sodium salt has to be classifiedhas harmful with risk phrase R22 (DSD) and Acute Tox. 4 with hazardous Statement H302 (CLP/GHS)
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