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Diss Factsheets
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EC number: 289-142-4 | CAS number: 86024-59-1
- 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 / corrosion, other
- Remarks:
- An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo study are available
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- January from 10th to 24th, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines. Justification for Read Across is detailed in the endpoint summary.
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:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted 17.7.1992
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 02
- IUPAC Name:
- Similar Substance 02
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England. The health of the animals was routinely examined for the main specific Pathogens by the breeder.
- Age at study initiation: healthy adult albino rabbits.
- Weight at study initiation: 3.8 - 4.1 kg
- Housing: individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions. Excrement trays beneath the cages contained low-dust (wood) bedding (type S 8/15, Ssniff Spazialdiaten GmbH, Soest). Bedding was regularly spot-checked for contaminants as required by the Department of Laboratory Animal Services, and changed at least twice weekly.
- Diet: standard diet "Ssniff K4" (ssniff Spezialdiaten GmbH, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
- Water: tap water (of drinking water quality), ad libitum.
- Acclimation period: prior to use the animals were acclimatized for approximately one week in the animal room.
- Health control: no vaccinations or treatment with antibiotics were performed prior to receipt of the animals, or during the acclimatization phase or study period. If females were used they were nulliparous and not pregnant. The animals were examined one day prior to the start of the
study to establish that they were biologically normal; only animals not exhibiting any alterations to skin or eyes were used.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 1.5 °C (higher when ambient temperature over 24 °C.
- Humidity: 50 - 70 %
- Air changes: 12 - 15 times per hour.
- Photoperiod: 12 hours light/dark cycle, artificial illumination from 6 a.m. to 6 p.m.; approx. 500 Lux.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
500 ng of the pulverized test substance were moistened with deionised water (to ensure good contact with the skin) and subsequently applied to a hypoallergenic Hansamed - patch (Beiersdorf No. 2342 PV3).
CONTROL
A further patch was moistened with water. The patch prepared in this way was placed on the opposite dorso-lateral area of the trunk of each animal respect to the test item one. - Duration of treatment / exposure:
- Four hours
- Observation period:
- 14 days
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: approximately 24 hours before the test, fur was shorn from the dorso-lateral area of the trunk (6 x 6 cm) of each of the rabbits (equipment: electric hair clipper). Care was taken to avoid abrading the skin. Only animals with healthy and intact skin were used.
REMOVAL OF TEST SUBSTANCE
- Washing: the exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epideinis. The contralateral skin area not treated with test substance be served as control.
- Time after start of exposure: 4 hours
SCORING SYSTEM
For each animal the Draize scores recorded approx. 24, 48, and 72 hours after application were recorded.
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (R) to slight eschar formation (S) (injuries in depth): 4R or 4S
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 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Results and discussion
In vivo
Results
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- other: mean at 24, 48 and 72 hrs
- Score:
- < 2.3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Evaluation of skin erythema was not possible in all three animals due to the intense colouration by the test substance.
Nevertheless, no other inflammatory signs (eschar or oedema formation) became apparent within the observation period of 7 days.
Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as ‘not irritating to the skin'.
Any other information on results incl. tables
Individual findings
Animals N. | Body weight | Draize grade after | |||||||||||
1 h | 24 h | 48 h | 72 h | 7 d | 14 d | ||||||||
E | O | E | O | E | O | E | O | E | O | E | O | ||
E2 | 4.1 kg | a | 0 | a | 0 | a | 0 | a | 0 | a | 0 | - | - |
F16 | 3.8 kg | a | 0 | a | 0 | a | 0 | a | 0 | a | 0 | - | - |
G9 | 3.8 kg | a | 0 | a | 0 | a | 0 | a | 0 | a | 0 | - | - |
E: Erythema
O: Oedema
a: exposed skin areas stained in colour of the test substance, evaluation of erythema not possible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Not irritating
- Executive summary:
Tests for the determination of irritant/corrosive effects of the substance on skin of albino rabbits were conducted in accordance with the OECD Guidelines Nos. 404. The albino rabbit is recommended as the preferred species in the guideline.
Evaluation of skin erythema was not possible in all three animals due to the intense colouration by the test substance. Nevertheless, no other inflammatory signs (eschar or oedema formation) became apparent within the observation period of 7 days.
Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as ‘not irritating to the skin'.
Conclusion
Not irritating
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