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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25.01.1995 - 08.02.1995
- 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.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Name of test material (as cited in study report): Coagulant 122 (solid)
Substance type: Clear slightly yellow liquid
Physical state: 80.4% solids
Batch number: 9435262-8489-A
Storage condition of test material: 4°C in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of exposure:
- 24 h
- Doses:
- 2.0 g/kg bodyweight
- No. of animals per sex per dose:
- A group of ten rats (five males and five females) was treared at 2.0 g/kg bodyweight.
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: There were no signs of systemic reaction to treatment. Slightly low bodyweight gains were recorded for three males and four females on Day 8, with a similar trend noted for three males and one female on Da
- Gross pathology:
- Effects on organs:
No macroscopic abnormalities were observed for animals
killed on Day 15. - Other findings:
- Signs of toxicity (local):
There were no signs of irritation or other dermal changes.
Any other information on results incl. tables
Mortality
There were no deaths following a single dermal application of Coagulant 122 (solid) to a group of ten rats (five males and five females) at a dosage of 2.0 g/kg bodyweight.
Clinical signs
There were no signs of systemic reaction to treatment.
Dermal responses
Sites of application of Coagulant 122 (solid) showed no irritation or other dermal changes (scores of zero for erythema and oedema were recorded for all animals).
Bodyweight (tables 1 and 2)
Slightly low bodyweight gains were recorded for three males and four females on Day g, with a similar trend noted for three males and one female on Day 15. All other rats achieved a satisfactory bodyweight gain throughout the study.
Macroscopic examination
No macroscopic abnormalities were observed for animals killed on Day 15.
Table 1 (Individual bodyweights (g))
Sex | Dose (g/kg) | Animal number & ear mark | Bodyweight (g) at | ||
Day 1 | Day 8 | Day 15 | |||
Male | 2.0 | 1 RP | 238 | 279 | 312 |
2 LP | 247 | 299 | 359 | ||
3 RPLP | 251 | 279 | 314 | ||
4 RIRO | 249 | 281 | 318 | ||
5 LILO | 248 | 291 | 344 | ||
Female | 2.0 | 6 RP | 232 | 243 | 266 |
7 LP | 214 | 222 | 236 | ||
8 RPLP | 217 | 218 | 232 | ||
9 RIRO | 231 | 250 | 285 | ||
10 LILO | 228 | 234 | 247 |
Table 2 (Individual bodyweight changes (g))
Sex | Dose (g/kg) | Animal number & ear mark | Bodyweight gains (g) at | |
Week 1 | Week 2 | |||
Male | 2.0 | 1 RP | 41 | 32 |
2 LP | 52 | 60 | ||
3 RPLP | 28 | 35 | ||
4 RIRO | 32 | 37 | ||
5 LILO | 43 | 53 | ||
Female | 2.0 | 6 PR | 11 | 23 |
7 LP | 8 | 14 | ||
8 RPLP | 1 | 14 | ||
9 RIRO | 19 | 35 | ||
10 LILO | 6 | 13 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance tested was Coagulant 122 (solid). The LD50 value was >2000 mg/kg.
Coagulant 122 (solid) will not require labelling with H312 category 4:Harmful in contact with skin", in accordance with Regulation (EC) No 1272/2008. - Executive summary:
A study was performed to assess the acute dermal toxiciry of Coagulant 122 (solid) to the rat. The method followed was that described in EEC Methods for the determination of toxiciry, Annex to Directive 92/69/EEC (OJ No. L3834, 29.12.92), Part B, Method 8.3. Acute toxicity (dermal).
A group of ten rats (five males and five females) was given a single dermal application of the test substance, as supplied at a dosage of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.
There were no deaths and no signs of systemic reaction to treatment.
Sites of application of Coagulant 122 (solid) showed no irritation or other dermal changes.
Slightly low bodyweight gains were recorded for three males and four females on Day 8, with a similar trend noted for three males and one female on Day 15. All other rats achieved a satisfactory bodyweight gain throughout the study.
No abnormalities were recorded at the macroscopic examination on Day 15.
The acute lethal dermal dose to rats of Coagulant 122 (solid) was found to be greater than 2.0 g/kg bodyweight.
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.
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