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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
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:
- weight of evidence
- Study period:
- From 28 February 2000 to 27 October 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is a screening test but followed international guidance requirements with acceptable restrictions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Screening test: only one animal is tested, no certificate of analysis included
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
Test material
- Test material form:
- other: Liquid at ambient temperature
- Details on test material:
- - Name of test material (as cited in study report): Dermalcare MAP L-213/K
- Physical state: clear liquid
- Stability under test conditions: assumed to be stable by the sponsor
- Storage condition of test material: ambient temperature
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 Italia S.p.A
- Age at study initiation: no data
- Weight at study initiation: 2.3 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: To: no data
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): 0.5 mL
- Concentration (if solution): not applicable
VEHICLE
not applicable - Duration of treatment / exposure:
- 4h
- Observation period:
- 7 days
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- % coverage: no data
- Type of wrap if used: test item was spread on a gauze square, placed onto the animal's skin and held in place by encircling the trunk of the animal with a length of elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
not applicable
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Erythema was observed in the tested animal, but not edema (see table 7.3.1/1)
- Other effects:
- none
Any other information on results incl. tables
Table 7.3.1/1:Irritant/corrosive response data at each observation time after each exposure time.
Score at time point (from the start of exposure) / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
0 |
0 |
24 h |
2 |
0 |
48 h |
2 |
0 |
72 h |
2 |
0 |
7 days |
0 |
0 |
Average 24h, 48h, 72h |
2.0 |
0.0 |
Reversibility*) |
c |
- |
Average time (day) for reversion** |
7 |
- |
*) Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible
**) Corresponds to the last day on which skin irritation signs in the last animal were observed
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Dermalcare MAP L-213/K was irritating to the rabbit skin. The mean erythema score (2.0) obtained in the one tested rabbit (screening test) does not allow to classify Dermalcare MAP L-213/K as a skin irritant according to the crieria of the Regulation (EC) 1272/2008 (CLP) but allows to classify as Xi, R38 according to the criteria of the Directive 67/548/EEC.
- Executive summary:
In a dermal irritation screening study performed similarly to the OECD guideline No. 404, one New Zealand White rabbit was dermally exposed to 0.5 mL of undiluted Dermalcare MAP L-213/K on a part of the trunk (6.25 cm²).Test site was covered with a semi-occlusive dressing for 4hours. The animal was then observed for 7 days. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.
The mean score calculated within 3 scoring times (24, 48 and 72 hrs) was 2.0 for erythema and 0.0 for edema.
Under the test conditions, Dermalcare MAP L-213/K was irritating to the rabbit skin. The mean erythema score (2.0) obtained in the only one tested rabbit (screening test) do not permit to classify Dermalcare MAP L-213/K as a skin irritant according to the criteria of the Regulation (EC) 1272/2008 (CLP) but permit to classify as Xi, R38 according to the criteria of the Directive 67/548/EEC.
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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