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Diss Factsheets
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EC number: 430-610-6 | CAS number: 226996-19-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 96/54/EG, B.6 (Magnusson-Kligman-Test); OECD 406 (1992)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- other: gpg, Dunkin-Hartley
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal injection: 2.5 % w/v in Alembicol D
b) Topical application: 60 % w/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
First challenge:
a) 30 % in Alembicol D
b) 60 % in alembicol D
Second challenge:
a) 20 % in Alembicol D
b) 40 % in Alembicol D
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal injection: 2.5 % w/v in Alembicol D
b) Topical application: 60 % w/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
First challenge:
a) 30 % in Alembicol D
b) 60 % in alembicol D
Second challenge:
a) 20 % in Alembicol D
b) 40 % in Alembicol D
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 %. No with. + reactions: 5.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 %. No with. + reactions: 5.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 60 %
Signs of irritation during induction:
Intradermal injection: Necrosis was recorded in all animals
receiving Freund's complete Adjuvant. Most animals displayed
slight irritation, with 2/10 showing well-defined irritation
and 1/10 animal showing moderate irritation. Slight
irritation was seen in control animals.
Topical application: 5/10 animals showed slight erythema,
5/10 showed well-defined erythema. Slight (4/5 animals) to
well defined (1/5 animals) erythema was seen in the control
animals.
Evidence of sensitisation of each challenge concentration:
At first challenge at 60 % w/v, the sample stuck to the skin
causing mechanical damage at bandage removal for all control
and test animals. No reactions were observed at 30 % w/v in
Alembicol D for any control or test animals.
Second challenge: There were no dermal responses in any of
the control or test animals.
Other observations:
One test animal was sacrificed for humane reasons following
the first challenge. Ulceration had been observed around the
site of injection prior to the challenge application. This
ulceration persisted and the animal became thin with an
ungroomed appearance. No abnormalities were observed during
post-mortem examination.
No signs of toxicity or ill-health were observed for the
remaining animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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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