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Registration Dossier
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Diss Factsheets
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EC number: 424-510-1 | CAS number: 220150-59-4
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 14. Aug. 1995 to 17. Aug. 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 424-510-1
- EC Name:
- -
- Cas Number:
- 220150-59-4
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- Reaction products of Phenol, 2,4-dinitro-, sulfurized, leuco derivatives and (3-chloro-2-hydroxypropyl)trimethylammonium chloride
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- CRL:KBL(N2W)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Stolzenseeweg 32-36, 88353 Kisslegg, Germany
- Age at study initiation: 16 weeks
- Weight at study initiation: male: 2.6 kg; females: 2.4 to 2.6 kg
- Housing: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing
- Diet: ad libitum; pelleted standard Kliba 341, batch 90/95 rabbit maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (contaminant analysis included in report)
- Water: ad libitum; community tap water from Itingen (bacteriological, chemical and contaminant analyses results included in report)
- Acclimation period: four days under test conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3
- Humidity: 30 to 70 %
- Air changes: 10 to 15 minutes
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- 10 cm x 10 cm area by electric clipper
- Vehicle:
- water
- Remarks:
- moistened only
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Males: 1
Females: 2
Total: 3 - Details on study design:
- TEST SITE
- Area of exposure: dorsal area measuring 10 cm x 10 cm
- % coverage: not specified
- Type of wrap if used: surgical gauze measuring 3 cm x 3 cm
REMOVAL OF TEST SUBSTANCE
- Washing: flushed with lukewarm tap water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after the removal of the test item
SCORING SYSTEM:
- Colouration, body weight, corrosion and toxic symptom observations
- Irritation scores (both erythema score and oedema score):
ERYTHEMA AND ESCHAR FORMATION (Maximum possible score: 4)
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
OEDEMA FORMATION (Maximum possible score: 4)
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- CORROSION
No irreversible alterations or corrosive effects observed.
IRRITATION
No irritation signs and symptoms observed. - Other effects:
- COLOURATION
The test article caused pale black staining of the treated skin until termination of the study. However, in the absence of signs of irritation, this finding was considered to be insignificant.
BODY WEIGHTS
The body weight gain of all rabbits was within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP criteria (EC 1272/2008)
- Conclusions:
- The test item was not found to be a skin irritant or a skin corrosive.
- Executive summary:
Skin irritation potential was evaluated in an experimental study according to the OECD Guideline 404 (1992) and EU method B.4 (1992). 0.5 g of undiluted, solid test item was applied to the shaved, dorsal area of three rabbits for a duration of 4 hours. Observations were recorded at 1, 24, 48 and 72 hours after removal of test substance. Irritation scores (mean 24, 48 and 72 hours) were 0.0 for both erythema and oedema in all test subjects. In the area of application, pale black staining of the treated skin was observed in all test subjects. No corrosive effect was observed. The test substance is not corrosive or irritating to the skin.
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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