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EC number: 288-306-2 | CAS number: 85711-46-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented, read across substance, according to GLP and OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1309959-24-7
- Cas Number:
- 1309959-24-7
- IUPAC Name:
- 1309959-24-7
- Test material form:
- liquid: viscous
- Details on test material:
- Physical state/ color: Liquid to high viscous / yellowish
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 5-6 month
- Weight at study initiation: 4.38 kg – 4.68 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4h
- Observation period:
- 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.
- Number of animals:
- 3 (2 females, 1 male)
- Details on study design:
- TEST SITE
- Area of exposure: flank
For better handling the test item was heated 1 hour at 70 °C. The test item was administrated lukewarm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4h
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 at least once each workday.
SCORING SYSTEM:
The evaluation of skin reactions was performed according to the quoted guidelines.
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:
- mean
- Time point:
- other: 24-72h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14d
- Irritant / corrosive response data:
- Directly after removal of the patch well-defined erythema (grade 2) was noted in all animals, increased to moderate erythema (grade 3) and was observed until hour 72 in two animals until study day 7. Thereafter well-defined erythema was noted again in these two animals on study day 14. In the third animal very slight erythema (grade 1) was noted on study day 7 and increased to well-defined again on study day 14. Slight edema (grade 2) was noted in all animals immediately after removal of the patch, was noted in two animals again at the 1 hour-reading and increased to moderate edema (grade 3) at the 24-hours reading. In these two animals slight edema was noted at hour 48 and 72, again. In one of these animals moderate edema was noted on study day 7 and 14, while in the otheranimal very slight edema was noted on study day 14. In the third animal moderate erythema , observed 1 hour after application, increased to severe edema (grade 4) at hour 24, decreased to moderate edema at hour 48 and 72 and persisted as slight edema until study termination
Scaling was noted in two animals on study day 7 and 14, in the third animal on day 14 only. Additionally yellowish discoloration of the application site was observed in one animal at hour 48 and 72 and in another animal on study day 7.
The cutaneous reactions were not reversible in all animals within 14 days after removal of the patch.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the described cutaneous reactions as well as the average score for irritation, the test item shows a skin irritating potential under the test conditions chosen
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