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Diss Factsheets
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EC number: 217-703-5 | CAS number: 1934-75-4
- 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)
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 February 2001 - 18 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study and according to GLP.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- included in the study report
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Main study:
Intradermal Induction: 5% w/w in distilled water
Topical Induction: 25% w/w in distilled water
Topical Challenge: 25% and 10% w/w in distilled water - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Main study:
Intradermal Induction: 5% w/w in distilled water
Topical Induction: 25% w/w in distilled water
Topical Challenge: 25% and 10% w/w in distilled water - No. of animals per dose:
- Selection of concentration for main study (sighting test):
---------------------------------------------------
Selection for conc. for Intradermal Induction:
Four animals using concentrations of 1%, 5%, 10% and 25% w/w in distilled water
Selection of Concentration for Topical Induction:
Two animals, treated with four preparation of the test material, 10%, 25%, 50% and 75% in distilled water.
Selection of Concentration for Topical Challenge:
Two animals, treated with four preparation of the test material, 5%, 10%, 25% and 50% in distilled water.
Main Study:
-----------
A group of fifteen guinea pigs were used (ten test and five control). - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Positive responses (discrete or patchy to moderate and confluent erythema) were noted
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Positive responses (discrete or patchy to moderate and confluent erythema) were noted.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy to moderate and confluent erythema was noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy to moderate and confluent erythema was noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Positive responses (discrete or patchy to moderate and confluent erythema) were noted
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Positive responses (discrete or patchy to moderate and confluent erythema) were noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy to moderate and confluent erythema was noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy to moderate and confluent erythema was noted.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- Transient challenge reactions (discrete or patchy erythema) were noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 5.0. Clinical observations: Transient challenge reactions (discrete or patchy erythema) were noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions were noted.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were noted..
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a 90% (9/10) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin under the conditions of the test. The test material produced a sensitisation rate of more than 30% and therefore, will be classified as skin sens. 1, H317 according to GHS/CLP
classification criteria. - Executive summary:
The substance was tested in a skin sensitisation study in the Guinea Pig (Magnusson and Kligman Maximisation Method) according to OECD 406, and GLP in year 2001. The test material produced a 90% (9/10) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin under the conditions of the test. The test material produced a sensitisation rate of more than 30% and therefore, will be classified as skin sens. 1, H317 according to GHS/CLP classification criteria.
Reference
Discrete or patchy to moderate and confluent erythema was noted at the intradermal induction sites of test group animals. No skin reactions were noted at the intradermal induction sites of control group animals. Discrete or patchy erythema was noted at the topical induction sites of all control group animals at the 1 -hour observation. No skin reaction were noted at the topical induction sites of control group animals at the 24 -hour observation. Bleeding from the intradermal injection sites was noted in all test group animals and four control group animals at the 1 -hour observation.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Migrated from Short description of key information:
The substance was tested in a skin sensitisation study in the Guinea Pig (Magnusson and Kligman Maximisation Method) according to OECD 406, and GLP in year 2001. The test material produced a 90% (9/10) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin under the conditions of the test.
Justification for selection of skin sensitisation endpoint:
OECD Guideline study and according to GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test material produced a 90% (9/10) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin under the conditions of the test. The test material produced a sensitisation rate of more than 30% and therefore, will be classified as skin sens. 1, H317 according to GHS/CLP classification criteria.
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