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EC number: - | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February to September 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Information removed from report
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 300-500 g
- Housing: Suspended metal cages with mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 24-56
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Induction intradermal- 0.5% (highest concentration to cause irritation without adverse effect on animals)
Induction topical - 25% (highest concentration to cause irritation without adverse effect on animals)
Topical challenge - 10 and 5% (based on 10% being the highest non-irritant concentration)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Induction intradermal- 0.5% (highest concentration to cause irritation without adverse effect on animals)
Induction topical - 25% (highest concentration to cause irritation without adverse effect on animals)
Topical challenge - 10 and 5% (based on 10% being the highest non-irritant concentration)
- No. of animals per dose:
- 20 test, 10 control, 5 positive
- Details on study design:
- Induction: On Day 1 three pairs of intradermal injections were administered to test animals. One week after the injections, an occlusive application of the test material was applied on the skin of the test animals, left for 48 hours. Control animals received analogous treatment without test material.
Observations on skin reactions occurred after ca. 24 hours following intradermal induction and following the removal of the dressings for the topical induction.
Challenge: Control and test animals were challenged topically two weeks after topical induction. The patches were sealed and left for 24 hours. A second challenge was conducted 8 days after the first challenge application. - Positive control substance(s):
- yes
- Remarks:
- HCA
Results and discussion
- Positive control results:
- Well defined irritation was seen in all animals receiving intradermal injections of HCA, at induction. Slight erythema was observed in positive control animals following topical application, at induction. The incidence index of sensitization for the positive control material was 1.0. The severity indices for the positive control animals at 24/48 hours were 2.6/3.0 for the anterior site and 2.6/1.8 for the middle site.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No signs of ill health or toxicity were recorded.
Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Slight to well-defined irritation was seen in test animals at sites receiving the test material.
Topical application: Slight erythema was observed in test animals, no erythema were seen in control animals.
First challenge: Slight to well-defined dermal reactions were observed for the majority of test and control animals at the 24, 48 and 72 hour readings. As it was unclear if the reactions represented sensitization, a second challenge was conducted to confirm reproducibility. The incidence index of sensitization for test substance was 0.95 for the anterior site (10%) and 0.8 for the middle site (5%). The severity indices for the test animals at 24/48 hours were 1.2/1.6 for the anterior site and 1.2/1.4 for the middle site. The severity indices for the control animals at 24/48 hours were 0.6/0.3 for the anterior site and 1.2/0.9 for the middle site.
Second challenge: Dermal reactions were observed for eleven test animals at both the 48 and 72 hour reading compared to none in the controls. Dermal reactions were observed for five test animals following the 72 hour score only, however due to the unusually late onset of these reactions they were considered as inconclusive responses. No reactions were observed for the remaining four test animals. The incidence index of sensitization of the test substance at second challenge was 0.55 at the posterior site (5%) and 0.1 at the middle site (1%).The severity indices for the test animals at 24/48 hours were 0/0.95 for the anterior site and 0/0.1 for the middle site. The severity indices for the control animals at 24/48 hours was 0 for both sites.
The dermal reactions noted for all 5 positive control animals were generally more marked and persistent than those seen for controls. The severity index for the control animals at 24/48 hours were 1.2/1.0 for the anterior site and 0.4/0.6 for the middle site.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In a Guinea Pig Maximisation skin sensitisation test, conducted according to OECD Test Guidleine 406 and in compliance with GLP, the test material was concluded to cause skin sensitisation. This was based on a positive response in eleven of the twenty test animals at re-challenge. Four animals gave negative responses and the remaining five animals gave inconclusive responses.
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.
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