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Diss Factsheets
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EC number: 417-040-3 | 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:
- 13.12.1995-04.02.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- These tests were conducted in 1995.
Test material
- Details on test material:
- Name of test material (as cited in study report): Coagulant 122 (solid)
Substance type: Clear slightly viscous yellow liquid
Physical state: 80.4% solids
Batch number: 9435262-8489
Storage condition of test material: 4°C in the dark under nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 15 healthy female nulliparous and non-pregnant albino guinea-pigs were in the weight range of 292 to 324 g on arrival and approximately four to seven weeks of age. All the guinea-pigs were acclimatised to the experimental environment for twelve days prior to allocation to the main study.
Animal room temperature was maintained at approximately 21°C and relative humidity at 30-70%. these environmental paramaters were recorded daily. Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12
hours of artificial light (0700-1900 hours in each 24 hours period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal injection - 4.02% v/v in water
Topical application - 80.4% v/v in water.
Concentration of test material and vehicle used for each challenge:
Topically: 80.4% and 40.2% v/v in distilled water.
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal injection - 4.02% v/v in water
Topical application - 80.4% v/v in water.
Concentration of test material and vehicle used for each challenge:
Topically: 80.4% and 40.2% v/v in distilled water.
- 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:
- 80.4 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40.2 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 80.4 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40.2 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
Any other information on results incl. tables
The sensitivity of the guinea-pig strain used is checked periodically ar HRC with hexyl cinnamic
aldehyde, a known sensitiser. The results of recent tests are presented in Appendix 3.
Maximum concentration not causing irritating effects in preliminary test: 80.4 %
Signs of irritation during induction:
Intradermal injections: Necrosis was recorded at the sites
receiving Freund's Complete Adjuvant in the test and control animals.
Slight irritation was seen in test animals at sites
receiving Coagulant 122 (solid), 4.02% v/v in water
Topical application:
Slight erythema was observed in test animals following
topical application with Coagulant 122 (solid), 80.4% v/v in
distilled water and slight erythema was seen in control guinea-pigs.
Evidence of sensitisation of each challenge concentration: None
Other observations:
There were no dermal reactions seen in any of the test or
control animals (only isolated incidence of localised dermalirritation and/or sloughing seen in two control and four
test animals.
No signs of ill health or toxicity were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Coagulant 122 solid does not require labelling with H317: May cause an allergie skin reaction in accordance with the Regulation (EC) 1272/2008.
- Executive summary:
A study was performed to assess the skin sensitisation potential of Coagulant 122 solid using the guinea-pig. The method followed was thar described in:
EEC Methods for the determination of toxicity, Annex of Directive 92/69|EEC (OJ No. L383A, 29.12.92), Part B, Method 8.6. Skin sensitisation.
MAGNUSSON, B. and KLIGMAN, A.M. (1970) Allergic Contact Dermatitis in the Guineapig: Idenrtfication of contact allergens, Thomas, c.c., springfield, Illinois, u.s.A.
Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:
Intradermal injection: 4.02% v/v in water for irrigation
Topical application: 80.4% v/v in distilled water
Challenge application: 80.4 and 40.2% v/v in distilled water
All concentrations are expressed in % vlv of solid content, based on a purity of 80.4% solids.
Ten test and five control guinea-pigs were used in this study.
In this study Coagulant 122 solid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
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