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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June to July 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, EPA, etc)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): XP-7866
- Substance type: White powder
- Physical state: Solid
- Analytical purity: 99.5 wt% obtained by H-NMR
- Purity test date: 99.5 wt%
- Lot/batch No.: 10188-1 JM
- Expiration date of the lot/batch: February 28, 2015
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: New Zealand White (Hsdlf:NZW) strain rabbits, supplied by Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: twelve to twenty weeks old at the start of the study.
- Weight at study initiation: 2.06 to 2.79 kg at the start of the study.
- Housing: Animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Rate of air changes (per hr): Fifteen changes per hours
- Photoperiod (hrs dark / hrs light): 12h/12h light/darkness (0.6:00 to 18:00)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 ml of distilled water to achieve a paste, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
Note:
* The absorption of the test item was not determined.
*The pH of the test item was determined prior to commencement of the study. the pH was for a preparation of 10% w/w aqueous preparation of the test item: 7.3 immediately and 7.6 after 10 minutes. - Duration of treatment / exposure:
- - One rabbit initially treated: on this rabbit, 3 suitable sites were selected. One patch was removed at each of three time points: 3 minutes, 1 hours and 4 hours after application.
- Two additional rabbits: 1 site during 4 hours. - Observation period:
- 1, 24, 48 and 72 hours after the removal of the patches
- Number of animals:
- 3 rabbits used
- Details on study design:
- TEST SITE
- Area of exposure: Test item introduced under a 2.5 cm x 2.5 cm cotton gauze patch.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
EVALUATION OF SKIN REACTIONS
- Erythema and Eschar Formation
* No erythema: 0
* Very slight erythema (barely perceptible): 1
* Well-defined erythema: 2
* Moderate to severe erythema: 3
* Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
- Oedema Formation
* No oedema: 0
* Very slight oedema (barely perceptible): 1
* Slight oedema (edges of area well-defined by definite raising): 2
* Moderate oedema (raised approximately 1 millimetre): 3
* Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Male 70638
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in the case of the experiment
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Male 70659
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in the case of the experiment
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Male 70661
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in the case of the experiment
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Male 70638
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in the case of the experiment
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Male 70659
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in the case of the experiment
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Male 70661
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in the case of the experiment
- Irritant / corrosive response data:
- The test item is not irritant to the skin according to the current experiment.
No corrosive effect has been recorded.
Any other information on results incl. tables
All animals showed expected gain in bodyweight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item has produced no observation on none of the 3 animals tested and at any time. According the results, the test item will not be classified based on the criteria fixed by the REGULATION (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:
• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal
Irritation/Corrosion" (adopted 24 April 2002)
• Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC)
No. 440/2008
Results.
* 3-minute and 1-hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.
* A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation.
Conclusion.
The test item has produced no observation on none of the 3 animals tested and at any time. According the results, the test item will not be classified based on the criteria fixed by the REGULATION (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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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