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EC number: 471-920-1 | CAS number: -
- 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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Summary
The skin sensitization potential of the test substance was evaluated in three sequential studies. Review of the various lines of evidence and SCL of 9.4% has been determined for this substance.
Data Analyses
In order to evaluate the skin sensitization potential, a series of studies were conducted and briefly summarized in the following table, and the substance showed weak to moderate sensitizing effects under testing conditions.
LLNA (3H labelled)
LLNA (BrdU labelled)
LLNA (BrdU labelled)
Guidance
OECD429
OECD429
OECD429
Test Item
Test substance
Test substance
Test substance
GLP (Y/N)
Y
Y
Y
Year
2/27/2006
5/30/2006
5/30/2006
Species
CBA/Ca mice
CBA/J mice
CBA/J mice
# animals
5/group
5/group
5/group
Method
Dose levels:
100%, 50% and 25% in acetone/olive oil 4:1
Dose levels:
25%, 10%, 5%, 2.5% and 1% in acetone/olive oil 4:1
Dose levels:
100%, 50%, 25% and 10% in acetone/olive oil 4:1
Result
Stimulation Index
Conc (%)
SI
25%
2.34
50%
4.15
100%
4.40
Stimulation Index
Conc (%)
SI
1
1.3
2.5%
2.3
5%
1.0
10%
3.3
25%
8.5
Stimulation Index
Conc (%)
SI
Ear thickness
10%
7.8
+25.0%
25%
11.6
+33.3%
50%
18.6
+76.2%
100%
14.4
+61.9%
EC3 = 35% (calculated)
EC3 = 9.4%
All scores were above 3; unable to calculate EC3
Conclusion
· Skin sensitizer
· Reliable study (Klimich =1)
· Supporting study
· Skin sensitizer
· Reliable study (Klimich =1)
· Key study
· Skin sensitizer, but severe local irritation effects were observed.
· Unreliable study (Klimich = 3).
· Discard study
Discussion
Information on the potency of sensitization based on the LLNA test is available for this substance.It is suggested that the LLNA EC3 value correlates relatively well with the NOEL from human sensitization tests designed to confirm lack of induction (Gerberick et al., 2001; Griem et al., 2003; Basketter et al., 2005). Among the two reliable LLNA studies, the one with lower EC3 was assigned as the key study and the study result represents the “worst case value”. Therefore, a threshold for skin sensitization can be defined as the EC3 concentration of 9.4%.
References
Basketter DA, Andersen KE, Liden C, Van Loveren H, Boman A, Kimber I, Alanko K, Berggren E (2005) Evaluation of the skin sensitizing potency of chemicals by using the existing methods and considerations of relevance for elicitation. Contact Dermatitis, 52: 39–43.
Gerberick GF, Robinson MK, Ryan CA, Dearman RJ, Kimber I, Basketter DA, Wright ZM, Marks JG (2001) Contact allergenic potency: Correlation of human and local lymph node assay data. American Journal of Contact Dermatitis, 12: 156–161.
Griem P, Goebel C, Scheffler H (2003) Proposal for a risk assessment methodology for skin sensitization based on sensitization potency data. Regulatory Toxicology and Pharmacology, 38: 269–290.
Migrated from Short description of key information:
The test material was positive for skin sensitisation in a key LLNA and one supporting LLNA study and one discarded LLNA study. A threshold for skin sensitization can be defined as the EC3 concentration of 9.4%.
Justification for classification or non-classification
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is required for skin sensitisation:
Category 1B, H317 may cause an allergic skin reaction.
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