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EC number: 280-055-7 | CAS number: 82864-58-2
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 11th to 14h, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Source study has reliability 1. Details on the read across are available in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- June 16, 2004
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France.
- Age at study initiation: 5 - 8 months.
- Weight at study initiation: 3.60 - 4.80 kg.
- Housing: single housing, stainless steel wire mesh cages with grating, floor area: 3000 cm².
- Diet: Kliba-Labordiät about 130 g/animal per day.
- Water: tap water. ad libitum.
- Acclimation period: at least 5 days before application. Before the beginning of application, the application area was investigated for signs of pre-existing skin irritation or dense patches of hair. Only animals with intact healthy skin were used.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 – 24 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- doubly distilled
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Preoparation: the solid test substance was minimally moistened with a suitable amount of doubly distilled water to guarantee skin contact immediately before test-substance application. Because of the natural moisture of the skin doubly distilled water was used for moistening, so that the test was carried out under conditions as physiological as possible. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 rabbits: 2 males, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: at least 24 hours before application clipping of the dorsolateral part of the trunk of the animal(s).
- Type of coverage: the test patch (2.5 x 2.5 cm) was secured in position with a semiocclusive dressing (Idealbinde, Pfälzische Verbandstoff-Fabrik,Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG).
REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed at the end of the exposure period with Lutrol®and Lutrol® / water (1 : 1) (Lutrol® E 400 = Polyethylenglycol, BASF Aktiengesellschaft).
- Time after start of exposure: 4 hours.
OBSERVATIONS
- Readings: Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.
- Illumination used for reading: daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany).
- Mortality: a check for any dead or moribund animal was made twice each workday (at the beginning and end of work) and once daily at weekends and on public holidays.
- Body weight determination: just before application of the test substance and after the last reading.
SCORING SYSTEM
The evaluation of skin reactions was performed according to the quoted guidelines. For evaluation, the calculation of the mean values of erythema and edema for readings at 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account. The evaluation is based on the criteria of the Commission Directive 67/548/EEC and the OECD Harmonized Integrated Classification System that were in place on the date of report signature.
Erythema and eschar formation - Grading
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to eschar formation preventing grading of erythema
Edema formation - Grading
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approx. 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Moderate erythema (grade 2) was observed in all animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema decreased to slight (grade 1) in two animals after 24 hours and in one animal after 48 hours.
Slight erythema persisted in one animal up to 48 hours.
The cutaneous reactions were reversible in one animal within 48 hours and in two animals within 72 hours after removal of the patch.
Mean scores over 24, 48 and 72 hours for each animal were 0.3, 1.0 and 0.7 for erythema and 0.0 for edema.
Any other information on results incl. tables
Reaciton | Readings (hours) | Mean 24, 48 and 72 hrs | |||||
Animal | 0 | 1 | 24 | 48 | 72 | ||
Erythema | Animal 01 (M) | 2 | 2 | 1 | 0 | 0 | 0.3 |
Animal 02 (M) | 2 | 2 | 2 | 1 | 0 | 1.0 | |
Animal 03 (F) | 2 | 2 | 1 | 1 | 0 | 0.7 | |
Oedema | Animal 01 (M) | 0 | 0 | 0 | 0 | 0 | 0.0 |
Animal 02 (M) | 0 | 0 | 0 | 0 | 0 | 0.0 | |
Animal 03 (F) | 0 | 0 | 0 | 0 | 0 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
The potential of the test substance to cause acute skin irritation was assessed according to the OECD guideline 404. Intact skin of 3 White New Zealand rabbits was exposed to 0.5 g of the test substance in a single topical application for 4 hours. A patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing was used. After removal of the patch, the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch. Slight or moderate erythema were observed in all animals during the course of the study. The cutaneous reactions were reversible in all animals within 72 hours after removal of the patch.
The average score (24 to 72 hours) for irritation was calculated to be 0.7 for erythema and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not show a skin irritation potential under the test conditions chosen.
Discussion and conclusion
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).
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