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EC number: 500-057-6 | CAS number: 27104-30-9
- 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:
- 04 July 2006 - 18 July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea
- EC Number:
- 500-057-6
- EC Name:
- Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea
- Cas Number:
- 27104-30-9
- Molecular formula:
- C5H16ClN2O5P
- IUPAC Name:
- Phosphonium, tetrakis(hydroxymethyl)-, chloride (1:1), polymer with urea
- Details on test material:
- technical product
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young healthy adult rats, age not reported, 13 days of acclimatisation; weight range: male 249-258 g, female 201-220 g; husbandry: individual caging at 12 h light and 12 h dark, 19-25°C, 30-70% relative humidity.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- A limit test was carried out involving a dose of 2000 mg/kg bw with five malev and female animals each.
A single dermal dermal administration followed by a 14-d observation period was performed.
One day before the start of the test the trunk of the animals was shaved. The test item was applied in pure form in a single dose on about 10% of the total body surface for 24 h. Sterile gauze pads were placed on the skin of the rats and kept in contact with the skin by hypoallergenic plaster. Then the entire trunk of the animal was wrapped with semiocclusive plastic wrap for 24 hours. At the end of the exposure period, resuidual test item was removed by using water with body temperature. - Duration of exposure:
- 24 hours single exposure
- Doses:
- On single dosis: 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- Clinical observations were done for 14 days: 1 h and 5 h after the end of exposure and once a day on the following days.
Individual observations were done on the skin, fur, eyes, mucous membranes, respiration, circulation, autonomic and central nervous system, somatomotoric activity and behaviour.
Body weight was determined at the start (day 0) and on days 7 and 14.
Gross necropsy was performed on all animals after 14 days. External appearance and abnormalities of the organs in the cranial, thoracic and abdominal cavities were recorded.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in this test.
- Clinical signs:
- other: No dermal changes in male rats. Female rats: erythema (5/5), epithelisation (5/5), necrosis (1/5). After 9-11 days, the skin in 4 of 5 animals returned to normal.
- Gross pathology:
- Pinprick-sized haemorrhages in the lungs (male 3/5, female 3/5) were observed.
One female had scar on the site of administration due to test item. - Other findings:
- Behaviour and general state of male and female animals were normal during the whole observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- AFLAMMIT SAP does not fulfill the criteria for classification and labelling according to the Commission Directive 2001/59/EC.
AFLAMMIT SAP was ranked into the WHO toxic class II-III (moderately/slightly hazardous).
AFLAMMIT SAP was ranked into the EPA toxci class III ("Caution").
Because of the skin effects (one animal showed necrosis and scar at the end of the recovery period) classification with "corrosive, R34" is considered to be necessary. - Executive summary:
A acute dermal toxity test was performed on the test item AFLAMMIT SAP using Wistar rats.The test item was applied in one dose (2000 mg/kg bw) for 24 hours followed by a 14 day observation period.
No mortalities occured in male and female rats (five male and five female): LD50 > 2000 mg/kg bw.
Symptoms in the skin were observed only in female rats and were reversible after 11 day with the exeption of one female rat, which showed necrosis and scar on the treated skin at necropsy.
Pinprick-size haemorrhages were observed in 3 of male and 3 of 5 female rats by necropsy after 14 days.
AFLAMMIT SAP does not fulfill the criteria for classification adn labelling according to the Commission Directive 2001/59/EC.
AFLAMMIT SAP was ranked into the classes WHO II-III (moderately/slightly hazardous) and EPA III ("Caution").
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