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EC number: 240-851-7 | CAS number: 16830-15-2
- 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
In view of these results, under these experimental conditions, the test item, in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives 67/548 and 99/45, must not be classified.
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:
- August 5, 2002 - September 19, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The MNNC was carried out at 25%, 12.5%, 6.25% and 3.125% in paraffin oil and diluted at 16% and 8% in ethanol/water 1 animal weighted 233g at the beginning instead of 250g These deviations have no influence on the development and the results of the study
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed in 2002.
LLNA method (OECD 442 B) was adopted in 2010. - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- albinos
- Sex:
- male
- Details on test animals and environmental conditions:
- 15 male albino guinea pigs of Dunkin-Hartley strain, supplied by Centre de Production Animale (F- 45160 Olivet) were exposed to the test product after a 5-day acclimatisation period. For the main study, the animals weighted between 233g and 353g at the beginning of the test.
- Route:
- intradermal
- Vehicle:
- other:
- Concentration / amount:
- 08/25/02: First induction
- 2 intradermal injections of the product diluted at 16% in an ethanol/distilled water (20/80: v/v) solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 32% in a ethanol/distilled water (20/80: v/v) solution.
08/30/02: Second induction
Topical application, on the same zone, with the product at 100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl sulfate at 10%. - Route:
- epicutaneous, occlusive
- Concentration / amount:
- 09/16/02: topical application under occlusive dressing at the
following concentrations : 100% and 50%.
09/17/02: 24-hours reading time.
09/18/02: 48-hours reading time and weighing. - No. of animals per dose:
- GROUP 1 (negative control) : 5 male guinea pigs identified n° C7276 to C7280;
GROUP 2 (treated) : 10 male guinea pigs identified n° C7291 to C7300; - Details on study design:
- Preliminary studies
08/01/02 Arrival of animals.
08/05/02 to 09/04/02 Preliminary tests : pre MNIC, MNNC, and MNIC determinations.
Main study
08/20/02 Arrival of animals.
Induction phase
08/25/02 1st induction
- 2 intradermal injections of the product diluted at 16% in an
ethanol/distilled water (20/80: v/v) solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a
physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 32% in a
ethanol/distilled water (20/80: v/v) solution.
08/25/02 Weighing of animals.
08/30/02 2nd induction:
topical application, on the same zone, with the product at
100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl
sulfate at 10%.
09/01/02 to 09/16/02 Rest phase: 15 days
09/16/02 Challenge phase : topical application under occlusive dressing at the following concentrations : 100% and 50%.
09/17/02 24-hours reading time.
09/18/02 48-hours reading time and weighing. - Positive control substance(s):
- yes
- Positive control results:
- In conclusion, in view of these results, under these experimental conditions, the substances
NEOMYCIN SULFATE and BENZOCAINE :
must be classified R 43 “may cause sensitization by skin contact” and in accordance with the
criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives
67/548 and 2001/59. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 6.25%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 6.25%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 75%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 38%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 38%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In view of these results, under these experimental conditions, the test item, in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives 67/548 and 99/45, must not be classified.
- Executive summary:
SUMMARY AND CONSLUSION OF THE STUDY
After induction (intradermic injection and topical application) of 10 animals (male) of treated group with the test item and a 15-days rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product at 100% and diluted at 50% in an ethanol/distiller water solution (20/80, v/v), according to the experimental protocol established from the O.E.C.D. guideline n°406 dated July 17th, 1992 and the method B.6 of the E.E.C. n°96/54 dated July 30th, 1996.
No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test product.
No cutaneous intolerance reaction was recorded in animals from the negative control group.
In conclusion, in view of these results, under these experimental conditions, the test item, must not be classified and in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives 67/548 and 99/45.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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.