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Diss Factsheets
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EC number: 228-055-8 | CAS number: 6104-30-9
- 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
Endpoint summary
Administrative data
Description of key information
A skin and an eye irritation study is available (BASF AG, 1967) which addresses both endpoints adequately.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited documentation, substance tested only as 50% dilution, observation/reading only at 24 hours and 8 days, only 2 animals tested
- Principles of method if other than guideline:
- The test substance was applied as 50% dilution for 20 hours under occlusive conditions. Observation/reading only at 24 hours and 8 days, only 2 animals tested
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: ca. 2.8 kg
- sex: male
no further data - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- Substance applied as a 50 % aqueous preparation (ca. 0.5 g on an area of about 2 .5 cm x 2.5 cm); occlusive application
- Duration of treatment / exposure:
- 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 24 hours and 8 days were selected as reading time points
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.
Reference
- Systemic toxicity: No mortality occurred. There were no signs of clinical toxicity from the dermal exposure.
- Irritation score: No skin findings were observed at any time
- Summary: Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited documentation, only 2 animals tested, only 50 µl applicated
- Principles of method if other than guideline:
- The test substance was applied as a single instillation (50 µl) as powder, the substance was not washed out, only 2 rabbits were used
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- no further data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: treated with talcum powder
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 microliter (50 mm3) - Duration of treatment / exposure:
- single instillation of the test substance as powder, the substance was not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none, substance not washed out - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean score observed for redness of the conjunctivae is 0.167 ( for 24, 48 and 72 hours) which is below 2.5.
These finding were reversible within 48 hours.
Reference
Summary:
The treatment led to slight redness. All findings were reversible after 8 days of observation period. The control eyes which were treated with talcum powder did show the same reactions.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In an older skin irritation study with 2 rabbits performed with ca. 0.5 g of a 50 % aqueous suspension of IBDU (purity ca. 90 - 96 %) under occlusive conditions for 20 hours, no local effects or other clinical signs were observed (reading time points: 24 hours and 8 days after application) (BASF AG, 1967).
Eye irritation
In an older eye irritation study with 2 rabbits performed with ca. 0.05 ml IBDU (purity ca. 90 -96%), slight redness (grade 1) was observed 24 hours after application in both animals. These findings were fully reversible within 48 hours (BASF AG, 1967).
Respiratory Tract
This information is not available
Justification for classification or non-classification
No classification and labeling is required, as no skin irritation was observed and eye irritation was marginal as only slight redness was observed after 24 hours, which was fully reversible after 48 hours.
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.
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