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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-08-1988 - 22-08-1988
- 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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
- Details on test material:
- Identification: Butyl benzotriazole, sodium salt
Physical state: dark brown solid
Purity: 82%
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at ambient temperature
- Stability under test conditions:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshlre, EngIand
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 2.2 - 2.7 kg prior to treatment at day 1
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Standard Rabbit diet ad libitum
- Water (e.g. ad libitum): Tap Water ad libitum
- Acclimation period: The rabbits selected for the study were all acclimated to the laboratory environment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): relative humidity at 30-70%
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours of artificial light (0700-1900 hours) in each 24 hours period
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Purity: distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4. Additional observations were made on Days 5 through 14.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square
- % coverage:
- Type of wrap if used: 2.5 cm square gauze pad moistened with 0.5 ml distilled water occluded with "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
Day 1: 30 minutes after removal of patches.
Day 2, 3 and 4
Days 5 through 14
The animals were not restrained during the exposure period and were returned to their cages.
(indicate if minutes, hours or days)
SCORING SYSTEM:
- Method of calculation: Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (neet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No Oedema 0
Very slight Oedema (barely perceptible) 1
Slight Oedema (edges of area well-defined by definite raising) 2
Moderate Oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: Days 1 - 3
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- Necrosis and chemical burns
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3
- Time point:
- other: Days 4 - 13
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- Necrosis
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3
- Time point:
- 14 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Remarks:
- Necrosis and scab formation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Days 1 - 6
- Score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Days 7 - 14
- Score:
- 1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Day 1 - 30 minutes after removal
- Score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Day 2 - 3
- Score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Days 4 - 14
- Score:
- 1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Days 1 - 3
- Score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Days 4 - 14
- Score:
- 1
- Remarks on result:
- positive indication of irritation
- Other effects:
- Necrotic lesions and reactions resembling a chemical burn were observed in aIl three animals. The necrotic lesions persisted throughout the study. Slight or moderate oedema was present in all three animals initially and very slight oedema persisted throughout the study. Scab formation was observed around the necrotic areas in all three animals on day 14.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- A single semi-occlusive application of butyl benzotriazole, sodium salt to intact rabbit skin for four hours elicited severe persistent dermal irritation.
The results of this study established that Butyl benzotriazole, sodium salt has to be classified:
Corrosive with Risk Phase R 34: Causes burns according Directive 67/548 EEC (DSD);
Skin Corr. 1B with Hazardous statement H131: cause severe skin burns and eye damage, according regulation (EC) 1272/2008 (CLP) - Executive summary:
A study was performed to assess the skin irritation potential of COBRATEC 435 (butyl benzotriazole, sodium salt) to the rabbit
The experimental procedure used was based on that recommended under Annex V directive 79/83I/EEC. Part B: Methods for the determination of toxicity. B4. skin irritation and OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion".
Three rabbits were each administred a single dermal dose of 0.5 g of the test substance and observed for 14 days
Severe persistent dermal irritation was abserved following a single semi-occlusive application of butyl benzotriazole, sodium salt to intact rabbit skin for four hours.
The results of this study established that Butyl benzotriazole, sodium salt has to be classified:
Corrosive with Risk Phase R 34: Causes burns according Directive 67/548 EEC (DSD);
Skin Corr. 1B with Hazardous statement H314: cause severe skin burns and eye damage, according regulation (EC) 1272/2008 (CLP)
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