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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01.08.1988 - 26.08.1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test is conducted before LLNA methods were available.
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: aqueous solution
- Details on test material:
- Identification: Butyl benzotriazole, sodium salt
Physical state: brown liquid
Purity: 37% aqueous solution
Storage condition: ambient temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- Sample received on 26 July 1988
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at ambient temperature in the dark
- Stability under test conditions: the stability and absorption of the test substance were not determined.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Forty female albino guinea-pigs of the Hartley/Dunkin strain were obtained from D. HaIl, Newchurch, Staffordshire, England. The guinea-pigs were acclimated to the Iaboratory environment for 18 days prior to allocation to the study.
The animals were randomly allocated to two groups:
20 control animals
20 test animals
The guinea-pigs were housed in suspended cages with wire mesh floors. They had free access to tap water and a vitamin C-enriched guinea-pig Diet
F.D.1. Hay was given weekly.
Animal room temperature was approximately 21°C and relative humidity 30-70%.
Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light in each 24 hour period.
AII animals were observed daily for signs of ill health or toxicity
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Based on the results of a preliminary investigation, the following concentration of Butyl benzotriazole, sodium salt 37% solution were selected:
Induction
Intradermal injection: 0.1% v/v water for irrigation
Topical application: 40% v/v in distilled water
Challenge
Topical application: 10% and 5% v/v in distilled water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Based on the results of a preliminary investigation, the following concentration of Butyl benzotriazole, sodium salt 37% solution were selected:
Induction
Intradermal injection: 0.1% v/v water for irrigation
Topical application: 40% v/v in distilled water
Challenge
Topical application: 10% and 5% v/v in distilled water
- No. of animals per dose:
- Control animals: 20
Test animals: 20 - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
One test animal was killed in extremis during the induction period. Signs of ill health inctuded noisy respiration, gasping, dark
eyes and lethargy. Autopsy revealed complete consolidation of anterior lung lobes with patchy consolidation of posterior lobes and pallor of liver: and kidneys. Death was not considered to be related to treatment.
One test animal was found dead prior to the challenge application. Tthe animal was autolysed and cannibalised and the cause of death could not be determined.
The bandage of a further one test animal came off prematurely. This animal was excluded from the final assessment.
The dermal reactions seen in six test animals were more marked than those seen in the controls.
In one further animal the dermal reactions were slightly more marked but not clearly different, from those seen in the controls.
The dermal response seen in the remaining ten animals was similar to the controls.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Butyl benzotriazole - sodium saIt 37% solution requires Iabelling the risk phrase with R43 "May cause sensitisation by skin contact" in accordance with the Directive 67/548/EEC and Hazardous Statement H317 "May cause an allergie skin reaction" in accordance with the regulation (EC) 1272/2008
- Executive summary:
A study was performed to assess the skin sensitisation potential of Butyl benzotriazole - sodium salt 37% solution using the guinea-pig.
The experimental procedure used followed the recommendations of:
1 - Annex V Part B Method B6 of the EEC Directive 79/831/EEC
2 - OECD Guideline for Testing of Chemicals No. 406 "Skin Sensitisation"
Based on the results of a preliminary study , the following dose levels were selected:
Induction:
Intradermal injection: 0.1% v/v in water for irrigation
Topical application: 40%% v/v in distilled water
Challenge
Topical application: 10% and 5% in distilled water
All concentrations are expressed in % v/v of 37% solution
twenty test and twenty control guinea-pigs were used in this study.
In this study, Butyl benzotriazole - sodium salt 37% solution produced evidence of skin sensitisation (delayed contact hypersensitivity) in six test animals.
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