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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 220-476-5 | CAS number: 2778-96-3
- 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
The skin sensitization potential of test chemical was assessed in various experimental studies conducted on human subjects. Based on the available data for the test chemical and supporting studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “non Skin Sensitizer”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by performing patch tests on humans. - GLP compliance:
- not specified
- Type of study:
- other: 2.guinea pig maximisation test 3.patch test
- Species:
- other: 2.guinea pig 3.humans
- Strain:
- other: 2.Hartley 3.Not applicable.
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 2. No data available.
- Route:
- intradermal
- Vehicle:
- not specified
- Remarks:
- 2.
- Concentration / amount:
- Test material diluted in FCA(0.1-mL injections of FCA)
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: eyeshadow formulation
- Remarks:
- 3.
- Concentration / amount:
- 10% in eyeshadow formulation
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 2.
- Concentration / amount:
- 0.0025% (undiluted test material)
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: eyeshadow formulation
- Remarks:
- 3.
- Concentration / amount:
- 10 % in eyeshadow formulation
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 2.
Total 14 animals
10 test group
2 positive control
2 Negative control.
3.
99 human volunteers - Details on study design:
- 2.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: No data available.
- Test groups: 10
- Control group: 4
- Site: Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body.
- Frequency of applications: No data available.
- Duration: No data available.
- Concentrations: Test material diluted in FCA(0.1-mL injections of FCA,)
B. CHALLENGE EXPOSURE
- No. of exposures: No data available.
- Day(s) of challenge: No data available.
- Exposure period: No data available.
- Test groups: 10
- Control group: 4
- Site: Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body.
- Concentrations: undiluted test material
- Evaluation (hr after challenge): No data available.
Other- Skin sensitization reaction were scored.
3.
Each subject was then examined at baseline and one, two, three, and four weeks after application. - Challenge controls:
- 2. Negative controls received distilled water
3. no data available - Positive control substance(s):
- yes
- Remarks:
- 2. 5% formalin 3.not specified
- Positive control results:
- 2. The 2 positive control animals received scores of 3.
- Reading:
- other: 2. challenge
- Group:
- test chemical
- Dose level:
- 0.0025% (undiluted test material)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitization reaction observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 99
- Clinical observations:
- The eye shadow formulation did not cause any dermal reactions to 99 volunteers tested.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3.
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical was considered to be not sensitizing to the skin on the basis of summarized studies.
- Executive summary:
Data available for the test chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:
The skin sensitizing test for test chemical was observed in Guinea pig by Guinea pig maximisation test. Group of 10 Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body. The test guinea pigs received two 0.1-mL injections of FCA, test material diluted in FCA in induction phase. While at challenge 0.0025% undiluted test material were given intradermally to 10 animals. Negative controls received distilled water and positive controls received 5% formalin. There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0. Under the conditions of the study, the makeup foundation containing 0.05% and 0.0025% of test chemical was not a sensitizer. Therefore the test chemical was considered to be non-sensitizing in Guinea pig .
Moreover,Draize Shelanski Patch test was performed to evaluate the dermal sensitization potential of test chemical present in an eye shadow formulation.The eye shadow formulation containing 10% test chemical was exposed to the skin of 99 human volunteers, and observed for dermal reactions (duration of exposure, observation period not specified).The eye shadow formulation didnot cause any dermal reactions to 99 volunteers tested.Hence,the eye shadow formulation containing 10% test chemical can be considered to be not sensitizing to human skin.
Based on the above summarized studies for target chemical ,it can be concluded that the test chemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Reference
2.
There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data available for the test chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:
The skin sensitizing test for test chemical was observed in Guinea pig by Guinea pig maximisation test. Group of 10 Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body. The test guinea pigs received two 0.1-mL injections of FCA, test material diluted in FCA in induction phase. While at challenge 0.0025% undiluted test material were given intradermally to 10 animals. Negative controls received distilled water and positive controls received 5% formalin. There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0. Under the conditions of the study, the makeup foundation containing 0.05% and 0.0025% of test chemical was not a sensitizer. Therefore the test chemical was considered to be non-sensitizing in Guinea pig .
Moreover,Draize Shelanski Patch test was performed to evaluate the dermal sensitization potential of test chemical present in an eye shadow formulation.The eye shadow formulation containing 10% test chemical was exposed to the skin of 99 human volunteers, and observed for dermal reactions (duration of exposure, observation period not specified).The eye shadow formulation didnot cause any dermal reactions to 99 volunteers tested.Hence,the eye shadow formulation containing 10% test chemical can be considered to be not sensitizing to human skin.
Based on the above summarized studies for target chemical ,it can be concluded that the test chemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance were observed in various studies. The results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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.