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EC number: 479-330-6 | CAS number: 67226-45-3
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Dec 23, 2008 - Jul 06, 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: For this endpoint supporting data for a main most critical degradation product are provided. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 402.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-Butylpyridinium chloride
- EC Number:
- 620-019-3
- Cas Number:
- 1124-64-7
- Molecular formula:
- C9H14ClN
- IUPAC Name:
- N-Butylpyridinium chloride
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Manston Road. Margate, Kent, UK
- Age at study initiation: group 1: appr. 8 weeks; group 2: appr. 8-9 weeks
- Weight at study initiation: group 1: 227-250 g (m), 176-190 g (f); group 2: 182-190 g and 213-243 g (f)
- Fasting period before study: overnight before dosing
- Housing: groups of3 in polypropylene cages
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 33 - 80 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 15
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 7 x 8 cm
- % coverage: 100
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution):
- Constant volume or concentration used: according to body weight
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/(kg bw
- No. of animals per sex per dose:
- 2000 mg/kg bw: 5 (m), 5 (f)
2000 mg/kg bw: 5 (f) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days: 1, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No formal stati stical analysis was conducted.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were 2 unscheduled deaths. One female was found dead on Day 2, approximately 19 1/2 h after dosing. The animal had shown no signs of reaction to treatment before death and there was no indication that its death resulted from the dosing procedure.
Another female from the additional females treated was euthanised approximately 3 1/4 h after dosing because of adverse signs of reaction to treatment. - Clinical signs:
- other: The female that was euthan ised displayed subdued behaviour, piloerection, red nasal and ocular discharge, wetness around the genital area and was cold to the touch from approximately 3 h after dosing. In the surviving animals there was no evidence of sys
- Gross pathology:
- The female found dead had red staining to the dorsum. This is considered to be evidence of erythema caused by the test item. The animal that was euthanised
had discolouring of the dorsal skin, which is also considered to be a result of test item application. The in-life finding of wetness around the genital area was also evident.
There were other find ings that are not untypical of background findings in rats of this strain and age on these study types, and, therefore they are considered not to be indicative of an effect of treatmenl. These included a mottled appearance of the kidneys of 2 males and enlarged mandibular lymph nodes in one female. The decedent had a dilated uterus.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The median dermal lethal dose (LD50) is greater than 2000 mg/kg bw.
- Executive summary:
Study Design
The study investigated the dennal toxicity potential of N-butylpyridinium chloride after a single administration to Sprague-Dawley rats. Five males and 5 females received N-butylpyridinium chloride at 2000 mg/kg bw. The test item was administered as supplied onto the water moistened clipped dorsal trunk and covered with a water moistened occlusive patch for 24 h. This study was performed according to GLP and the methods applied are fully compliant with OECD TG 402.
Results
All 5 males survived treatment. One female was found dead on Day 2, approximately 19h after dosing, and, consequently. a second group of 5 females received N-butylpyridinium chloride at 2000 mg/kg bw. One of these females was euthanised approximately 3h after dosing because of adverse signs. All animals were observed for adverse signs up to 14 days after dosing and all animals received a gross necropsy.
The female found dead on Day 2 had shown no signs of reaction to treatment before death and there was no ind ication that its death resulted from the dosing procedure. Necropsy findings revealed that the dorsal skin was stained red. The female that was euthanised approximately 3h after dosing displayed subdued behaviour, piloerection, red nasal and ocular discharge, wetness around the genital area and was cold to the touch. Necropsy findings revealed red staining or discolouration to the dorsum and wetness around the genital area.
Among the males and the surviving females there were no other systemic signs recorded and only local findings at the site of test item application were noted. These included erythema, reddening of the dorsal surface, flaking skin and dry scabbing. These signs had resolved by Day 10.
Body weight gains were considered to be acceptable for rats of this age and strain and there were no necropsy findings in the surviving animals that were considered to be related to treatment.
Conclusion
Under the conditions of the study, a topical dosage of 2000 mg/kg bw of N-butylpyridinium chloride to Sprague-Dawley rats resulted in the unscheduled death of 2 of 15 animals and caused local irritation at the treatment site. It is considered that the median dermal lethal dose (LD50) is greater than 2000 mg/kg bw.
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