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Diss Factsheets
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EC number: 947-998-2 | CAS number: -
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 15, 2001 - June 18, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the amount of the aqueous solution applied was 0.5 g instead of 0.5 mL
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the amount of the aqueous solution applied was 0.5 g instead of 0.5 mL
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amphoacetates C12
- Cas Number:
- 68608-66-2
- IUPAC Name:
- Amphoacetates C12
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- other: aqueous solution
- Details on test material:
- Name of the test material (as cited in the report): Miranol H2M CONC
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A. (Como) and bred by P.O.A.D.A., Mandello Lario (Como), Italy.
- Age at study initiation: 9 to 11 weeks at ordering; 10-12 weeks at study initiation
- Weight at study initiation: approximately 2 kg at ordering; 2.3-2.7 kg at study initiation
- Housing: stainless steel cages (63x48x41 cm) equipped with grid floors. Cages were suspended over trays and each tray held an absorbent materiel inspected and changed as necessary.
- Diet (e.g. ad libitum): ad libitum (pelleted diet from Altromin MSK, Altromin, D-32770 Lage, Postfach 1120, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21 °C
- Humidity (%): 40-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: the day before dosing the dorsal surfaces of the trunk of each animal, on both sides of the midline, were clipped free of hair using an electric clipper equipped with a suitable blade
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: comparison with adjacent untreated skin
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration (if solution): the test material was applied as such (aqueous solution) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm (6.25 cm^2)
- Type of wrap if used: gauze + aluminium
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated sites were cleaned by gentle swabbing of the skin with cotton wool soaked in water at approximate body temperature
- Time after start of exposure: 4 hours
SCORING SYSTEM: according OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: solid content of the test material: 50%
- Irritant / corrosive response data:
- See section "Any other information on results incl. tables"
Any other information on results incl. tables
Scores for erythema reactions | |||||
ERYTHEMA | 1h | 24h | 48h | 72h | Individual mean scores (24, 48 and 72h) |
Rabbit 1 | 1 | 1 | 1 | 0 | 0.7 |
Rabbit 2 | 1 | 1 | 1 | 0 | 0.7 |
Rabbit 3 | 1 | 1 | 0 | 0 | 0.3 |
Scores for oedema reactions | |||||
OEDEMA | 1h | 24h | 48h | 72h | Individual mean scores (24, 48 and 72h) |
Rabbit 1 | 1 | 1 | 0 | 0 | 0.3 |
Rabbit 2 | 1 | 1 | 0 | 0 | 0.3 |
Rabbit 3 | 1 | 1 | 0 | 0 | 0.3 |
Other information:
- The animals had a normal weight gain during the 4 days(0.1 kg)
- No indication of a systemic effect
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritation potential of a related member of amphoacetates C12 has been investigated according to OECD 404 and GLP. On the basis of the obtained results, the test material (solid content 50%) is not classified as a skin irritant according to the criteria of the CLP Regulation.
- Executive summary:
The skin irritation potential of a related member of amphoacetates C12 has been investigated according to OECD 404 and GLP. The test material (aqueous solution at approx. 50% solids) was tested for acute dermal irritation in 3 female New Zealand White rabbits, according to OECD 404/EC method B.4, and in compliance with Good Laboratory Practice. The test material, was applied as such on a gauze, in a single dermal dose of 0.5 g, to a 2.5 x 2.5 cm clipped area of the skin, during 4 hours under a semi-occlusive dressing. The cutaneous examinations were performed at 1, 24, 48 and 72 hours after removal of the dressing. The application of the preparation produced very slight erythema (score 1) in all animals at 24 hours but only in two animals at 48 hours after patch removal. The reversibility was complete at 72 hours in all animals. Very slight edema was observed in all animals but only at 24 hours. No other reactions were observed after. The mean individual scores calculated over the 24-72 hour period for each animal were (0.7-0.7-0.3) for erythema, and (0.3-0.3-0.3) for edema. On the basis of these results, the test material (solid content 50%) is not classified as a skin irritant according to the criteria of the CLP Regulation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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