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EC number: 211-103-7 | CAS number: 629-70-9
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 October 1956 to 27 December 1956
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Intracutaneous injection of test material in physiological saline on alternate days to a total of ten injections in each of eight male guinea pigs.
- GLP compliance:
- no
- Remarks:
- investigation took place prior to introduction of GLP
- Type of study:
- intracutaneous test
- Species:
- guinea pig
- Strain:
- other: White
- Sex:
- male
- Details on test animals and environmental conditions:
- - Eight, normal, healthy, white male guinea pigs, each weighing 300 to 400 g, were used for the experiment.
- Animals were maintained on a regular diet of rabbit pellets supplemented with spinich and kale throughout the experiment.
- As much hair as possible was removed from the sides and back of each guinea pig with electric clippers. - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % suspension of test material
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % suspension of test material
- No. of animals per dose:
- Eight
- Details on study design:
- - The test material was made up as a 0.1 % suspension in physiological saline and injected using a 0.25 mL syringe with a 0.5 inch 26 gauge needle.
- Injections were made every other day until a total of ten had taken place.
- The first injection was 0.05 mL while the remaining injections were all 0.1 mL.
- An area consisting of 3-4 cm2 was used for the site of the injection. However, the inital injection was given slightly below the sensitisation area.
- Two weeks after the final injection, a test injection of 0.05 mL of a freshly prepared suspension was administered.
- Reaction readings were made 24 hours after the initial and final 0.05 mL injections. - Positive control substance(s):
- no
- Positive control results:
- Not applicable
- Reading:
- 1st reading
- Clinical observations:
- Small raised areas
- Remarks on result:
- other: Reading: 1st reading. Clinical observations: Small raised areas.
- Reading:
- rechallenge
- Clinical observations:
- No effects greater than initial injection
- Remarks on result:
- other: Reading: rechallenge. Clinical observations: No effects greater than initial injection.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced no sensitising effects in the guinea pig.
- Executive summary:
METHOD
A mixture declared to contain 90 % of test item was prepared as a 0.1 % suspension in physiological saline and administered to eight male guinea pigs by intracutaneous injection (initial injection of 0.05 mL in physiological saline followed by injections of 0.1 mL to a total of ten).
RESULTS
Twenty four hours after the initial injection, small raised areas were observed. These areas showed a slight increase in colour when compared to the surrounding area and the swellings were approximately 4-5 mm in diameter and 3-4 mm in height.
Fourteen days after the last sensitising injection was given, 0.05 mL of a new 0.1 % suspension showed no greater effects than did the initial injection.
CONCLUSION
The test material produced no sensitising effects in the guinea pig.
Reference
- Twenty four hours after the initial injection, small raised areas were observed.
- These areas showed a slight increase in colour when compared to the surrounding area.
- The swellings were approximately 4-5 mm in diameter and 3-4 mm in height.
- Fourteen days after the last sensitising injection was given, 0.05 mL of a new 0.1 % suspension showed no greater effects than did the initial injection.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a key study, conducted before the introduction of GLP, a mixture declared to contain 90 % of test item was prepared as a 0.1 % suspension in physiological saline and administered to eight male guinea pigs by intracutaneous injection (initial injection of 0.05 mL in physiological saline followed by injections of 0.01 mL to a total of ten).
Twenty four hours after the initial injection, small raised areas were observed. These areas showed a slight increase in colour when compared to the surrounding area and the swellings were approximately 4-5 mm in diameter and 3-4 mm in height. Fourteen days after the last sensitising injection was given, 0.05 mL of a new 0.1 % suspension showed no greater effects than did the initial injection. The test material was reported to cause no sensitising effects in the guinea pig.
In a second study, involving 56 human volunteers, the test material did not elicit any visible response in 50 out of 53 to whom 50 % test material in petrolatum (equivalent to 45 % of the test item described in this dossier) was applied to the same dermal site for 24 hours on four consecutive days for a period of three weeks. Furthermore, no evidence of skin sensitisation was found and it was predicted with 95 % certainty that at least 92.89 % of a general population would not be sensitised by the test material. It can therefore be concluded that the test item described in this dossier does not cause skin sensitisation in humans at a concentration of 45 %.
Migrated from Short description of key information:
Pre-GLP animal study concluding that a mixture declared to contain 90 % of test item did not cause sensitisation in the guinea pig supported by human data showing that the same test material did not elicit any visible response in 50 out of 53 volunteers who took part in the study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No evidence for skin sensitisation was reported in a pre-GLP study on the guinea pig and these data are supported by a second study involving 56 human volunteers. As a result, the test item is not classified as a skin sensitiser under the terms of Regulation (EC) No 1272/2008.
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