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Diss Factsheets
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EC number: - | 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:
- Not stated.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 1992-06-11
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): ITC 288 (reaction mixture consisting mainly of the following components: n=1= phosphonoethane-1,2-dicarboxylic acid tetrasodium salt and n = 2= 1-phosphonobutane-1, 2, 3, 4-tetracarboxylic acid hexasodium salt)
- Physical state: white powder
- Storage condition of test material: room temperature under silica gel
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 10-14 weeks old
- Weight at study initiation: 234-243 g (males) 207-229 g (females)
- Fasting period before study:
- Housing: individually
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 60-75
- Air changes (per hr): 15
- Photoperiod : 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 23 September 1992 To: 7 October 1992
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: no data
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage (Hypertie). The bandage was further secured with a piece of BLENDERM wrapped around each end.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin and surrounding hair were wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes
- Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: none - Statistics:
- No statistics were performed.
Results and discussion
- Preliminary study:
- No preliminary study was performed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No data
Any other information on results incl. tables
Table 7.2.3/2: Number of animals dead
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity(#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, the acute dermal median lethal dose of ITC 288 in the rat was found to be greater than 2000 mg/kg bodyweight. The test substance is not classified according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).
- Executive summary:
In an acute dermal toxicity study (Tuffnell, 1992), male and female Sprague-Dawley rats were dermally treated for 24 hours with ITC 288, up to at least 10 % of the body surface was in contact with the test material, at a dose level of 2000 mg/kg bw. Animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination. There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. Moreover, body weight gains were acceptable during the study period. Under the conditions of this test, the LD50 of ITC 288 in rats is greater than 2000 mg/kg bw. Based on these results, no classification is required according to the EU legislation ( CLP regulation (1272/2008) and Directive 67/548/EEC).
This acute dermal study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study.
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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