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Diss Factsheets
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EC number: 411-410-8 | CAS number: 118562-73-5
- 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:
- Test according to OECD guideline 404 and according to the US-GLP regulations (U.S. Fed. Reg., Title 21, CFR, Part 58, September 4, 1987)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-07-18 to 1990-07-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test according to OECD guideline 404 and according to the US-GLP regulations (U.S. Fed. Reg., Title 21, CFR, Part 58, September 4, 1987), but lack of data on the purity / quality of the sample tested.
- Remarks:
- Test according to OECD guideline 404 and according to the US-GLP regulations (U.S. Fed. Reg., Title 21, CFR, Part 58, September 4, 1987), but lack of data on the purity / quality of the sample tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydroxyambran
- IUPAC Name:
- Hydroxyambran
- Reference substance name:
- 2-(Cyclododecyl)-propan-1-ol
- IUPAC Name:
- 2-(Cyclododecyl)-propan-1-ol
- Test material form:
- solid: crystalline
- Details on test material:
- Hydroxyambran
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals:
Species: rabbit
Strain: White New Zealands
Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
Date of receipt July 10, 1990
Acclimation period: at least 7 days
Animal selection: random
Animal identification: with individual earmarks; cage labelled with the following information: earmark, sex, date of study initiation, project no.
Weight range at
study initiation: 2.4 - 2.8 kg
Husbandry:
Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system.
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 18 +/- 2 °C
Relative humidity: 50 – 85 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-MÜ Z (Alleindiät für Zuchtkaninchen)
Form: Pellets
Water: Administration: ad libitum
System: drinking nipples
Quality: drinking water as for human consumption
Quality control: analytical and bacteriological controls every six months
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml on approx. 6 cm²
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- Preparation of the Animals:
Prior to test initiation, all animals were acclimated to laboratory conditions for at least 7 days. 24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was subsequently examined for abrasion and animals with healthy, intact skin were then earmarked for individual identification.
Preparation of the Test Article:
The test article was applied undiluted.
Procedure:
In each animal, 0.5 ml of the test article were applied to the test site (approx. 6 cm² in size) an adjacent area of untreated skin serving as a control. Each test area was covered with a semi-occlusive dressing consisting of Kosmoplast (Medilog), which was held in place by non-irritating tape Elastoplast (Beiersdorf Ag, Hamburg), and Stülpa (P. Hartmann AG, Heidenheim /brenz), which enveloped the whole animal’s trunk. At the end of the 4h exposure period, the dressing was removed and any residual sample was carefully washed away.
Observations:
Signs of erythema and oedema were recorded at 30-60 min, 24, 48 and 72 h after patch removal. Dermal irritation was evaluated according to a same scheme as presented in the REGULATION (EC) No 44/2008, B.4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30-60 min
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Not any sign for irritation/corrosion was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article "Hydroxyambran" can be classified as "not irritant".
- Executive summary:
The acute dermal iritation/corrosion of Hydroxyambran was determined according to the OECD Test Guideline 404 in rabbits.
Not any sign for irritation/corrosion was observed.
The test article "Hydroxyambran" can be classified as "not irritant".
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