Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 259-033-6 | CAS number: 54229-13-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of experimental phase: 23 March 2017 End of experimental phase: 07 April 2017 Study completion: 08 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted on 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA, OPPTS Methods 870.1000 “Acute Toxicity Testing - Background
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride
- EC Number:
- 259-033-6
- EC Name:
- [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride
- Cas Number:
- 54229-13-9
- Molecular formula:
- C21H29ClN5O3.Cl
- IUPAC Name:
- [2-({4-[(E)-2-(2-chloro-4-nitrophenyl)diazen-1-yl]phenyl}(ethyl)amino)ethyl](2-hydroxypropyl)dimethylazanium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Species and strain: Rat, Hsd: Sprague Dawley SD
Sex: Males and females (nulliparous and non-pregnant)
Age: 6 to 8 weeks old
Weight ordered: 176 to 200 grams
Supplier: Envigo RMS s.r.l., San Pietro al Natisone (UD), Italy
Breeder: Envigo RMS B.V., Kreuzelweg 53, 5961 NM Horst, Netherlands
Date of arrival: 15March 2017
Weight range at arrival: 188 to 198 grams for males; 189 to 197 grams for females
Acclimatisation period: At least 5 days
Veterinary health check: During acclimatisation period
ENVIRONMENTAL CONDITIONS
Animals per cage: Up to 5 of one sex during acclimatisation; individually caged during the study
Housing: Clear polysulphone H-Temp solid bottomed cages (Tecniplast Gazzada S.a.r.l., Buguggiate, VA, Italy) measuring 59.5×38×20cm during
acclimatisation period and 42.5×26.6×18.5cm during the study with nesting material provided into suitable bedding bags.
Cage control: Daily inspected and changed as necessary (at least 3 times/week)
Water Drinking water supplied to each cage via a water bottle
Water supply: Ad libitum
Diet: 4 RF 18 (Mucedola S.r.l., Via G.Galilei, 4, 20019, Settimo Milanese (MI) Italy)
Diet supply: Ad libitum throughout the study
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 20 air changes per hour
Temperature range: 22 °C±2 °C
Relative humidity range: 55%±15%
Administration / exposure
- Type of coverage:
- semiocclusive
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal surfaces of the trunk
- % coverage: Approximately 10% of body surface
- Type of wrap if used: Elastic adhesive bandage and gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with cotton wool soaked with lukewarmwater
- Time after start of exposure: 24 hours
- Duration of exposure:
- The animals remained in contact with the test item for 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males and 5 females at 2000 mg/kg body weight
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs the day of dosing: on dosing, approximately 1 hour after dosing, 2 hours after dosing, approximately 4 hours after dosing. Daily thereafter for a total of 14 days. All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat. (total fraction)
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality occurred.
- Clinical signs:
- Only red staining at the treated site, due to the colour of the test substance, was observed in all male and female animals from Day 2 up to the end of the
observation period. - Body weight:
- Body weights and body weight changes were within the expected range for this species and age of animals at the end of the study.
- Gross pathology:
- Red staining at the treatment site was observed in all animals during the external examination performed on all animals at termination of the study. No internal abnormalities were noted during the necropsy procedure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute toxicity of Basic Red 18:1 Chloride was investigated following dermal administration of a single dose to the rat at 2000mg/kg body weight.
No mortality occurred following dosing and no signs of toxicity were observed.
These results indicate that the test item, Basic Red 18:1 Chloride, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of
2000mg/kg body weight.
The lack of mortality demonstrates the LD50 to be greater than 2000mg/kg body weight.
European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent
revisions) would suggest the following:
Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required - Executive summary:
The acute toxicity of Basic Red 18:1 Chloride was investigated following dermal administration of a single dose to the rat.
A single dose of 2000mg/kg body weight was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days, all animals were killed and subjected to necropsy examination.
No mortality occurred and only red staining at the treated site, due to the colour of the test substance, was observed in all male and female animals from Day 2 up to the end of the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals.
Only red staining at the treatment site, due to the colour of the test substance, was found at necropsy in all animals at termination of the study.
These results indicate that the test item, Basic Red 18:1 Chloride, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000mg/kg body weight. The lack of mortality demonstrates the LD50 to be greater than 2000mg/kg body weight. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC)No. 1272/2008 and subsequent revisions) would indicate the following:
Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.