Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 256-783-6 | CAS number: 50814-31-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40215.
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Source study has reliability 2. Details on the read across are attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- Appraisal of the safety of chemicals in foods drugs and cosmetics (1959) by AFDO.
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 1.6 kg
- Housing: Singly in metal cages, overall dimensions 47×32×34 cm
- Diet: Nafag, ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hrs light day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days
- Number of animals:
- 6 rabbits, 3 males and 3 females
- Details on study design:
- The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 × 2.5 cm with test substance was applied immediatly to the prepared skin. The patch was covered with an impermeable foil of 5 × 5 cm, which was fixed to the body of the animals with adhesive tape.
Test substance was applied to each side in quantities of 0.5 g. Before application, test material was wetted with tap water.
The gauze patches were removed 24 hours after application. Skin reaction was appraised upon removal during an observation period of 8 days on the basis of erythema and edema formation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 026/M
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 026/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 028/M
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 028/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 030/M
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 030/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- 007/F
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- 007/F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- 009/F
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- 009/F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- 011/F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- 011/F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Results tabulated
animal no. | erythema | oedema | mean erythema | mean oedema | ||||
24 h | 48 h | 72 h | 24 h | 48 h | 72 h | |||
1 | 1 | 0 | 0 | 0 | 0 | 0 | 0.33 | 0 |
2 | 1 | 0 | 1 | 0 | 0 | 0 | 0.66 | 0 |
3 | 0 | 1 | 0 | 0 | 0 | 0 | 0.33 | 0 |
4 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
5 | 1 | 0 | 0 | 0 | 0 | 0 | 0.33 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Erythema and Eschar Formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Total possible erythema score 4
Edema formation
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised appoximately 1mm)
4 Severe edema (raised more than 1mm and extending beyond area of exposure)
Total possible edema score 4
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The substance was tested as described in Appraisal of the safety of chemicals in foods drugs and cosmetics of 1959 by AFDO.
Under the conditions of the experiments the substance is not irritant when applied to intact skin of rabbits. - Executive summary:
Method
6 rabbits (3 males and 3 females) of the Russian breed were used. Test substance was applied on both intact and abraded skin in amount of 0.5 g. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days.
Results
On intact skin, slight signs of erythema and oedema were noted in 5/6 rabbits. Such signs were found to be reversible within 8 days.
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.