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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
Endpoint summary
Administrative data
Description of key information
Skin: The skin of one rabbit was exposed to undiluted Dermalcare MAP L-213/K or Dermalcare MAP L-210 under a semiocclusive dressing for 4 hrs or 3 min, 1 hr and 4 hrs, respectively. Dermalcare MAP L-213/K induced well-defined erythema but this effect was fully reversible by day 7. The scores obtained for erythema induced the classification of Dermalcare MAP L-213/K as Xi, R38 according to the criteria of the Directive 67/548/EEC. The scores obtained for erythema do not allow to classify according to the CLP criteria but as the cutaneous effect was significant and by precaution, Dermalcare MAP L-213/K is also classified as skin irr. 2 (H315) according to Regulation (EC) 1272/2008.
Dermalcare MAP L-210 induced stronger irritant effects particularly after an exposure of 1 hr. Severe erythema was observed from 4 hours to 7 days after removal of the dressing and a moderate edema was also observed. Necrotic areas were observed from 24 hrs to 7 days. On day 14, desquamation and scabs were persisting. Following a 4 hr exposure, a severe erythema at 4 hours after the removal of the dressing reducing to a moderate erythema to 72 hours, and a slight edema were observed. However no necrotic areas were observed. The only effect persisiting to the 14 day observation period was desquamation. Therefore Dermalcare MAP L-210 was considered to be irritating to the skin (Skin irr. 2 (H315)) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R38 according to the Directive 67/548/EEC) and not corrosive due to the results obtained following the 4 hr exposure time.
Eye: The eye of one rabbit was exposed to undiluted Dermalcare MAP L-213/K without rinsing. The test substance induced irreversible damage on the cornea and on the iris of the rabbit eye (21 days of observation). Dermalcare MAP L-213/K is classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : screening study, only one tested animal, no certificate of analysis included
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A
- Age at study initiation: no data
- Weight at study initiation: 2.8 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable
VEHICLE
not applicable - Duration of treatment / exposure:
- the eye was not rinsed after administration of test item
- Observation period (in vivo):
- Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the instillation and then at days 7, 14 and 21.
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
not applicable
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Corneal opacity was observed at 24 and 48 hours (grade 1) and persisted with grade 2 from 72 hours until the end of the study period (day 21). Iris inflammation (grade 1) was observed from the 24-hour observation until the end of the study. The mean scores calculated over the 24-48-72 hours period were 1.33 for corneal opacity, and 1.0 for iris inflammation.
Conjunctival reactions, redness (grade 2) and chemosis (grade 2 or 3) were observed between 1 and 72 hours, and then cleared by day 21. The mean scores (24-48-72 hours) were 2.0 for conjunctival redness, and 3.0 for chemosis. In addition, discharge was observed between 1 and 72 hours following administration (see details in Table 7.3.2/1). - Other effects:
- none
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Dermalcare MAP L-213/K induced irreversible eye damage (persistent corneal and iridal effects on day 21) and is therefore classified as Eye Dam. 1 (H318) according to the criteria of the Regulation (EC) 1272/2008 (CLP) or to the criteria of the Directive 67/548/EEC.
- Executive summary:
In an eye irritation screening study performed similarly to the OECD No. 405 guideline, 0.1 mL of undiluted Dermalcare MAP L-213/K was instilled into the conjunctival sac of right eye of one male New Zealand White Rabbit. After the instillation the substance was not rinsed off. The animal was then observed for 21 days for eye edema and erythema of the conjunctivae, corneal opacity and iris lesion. Eye irritation was assessed and scored according to the Draize scale at 1,24, 48 and 72 hrs, 7, 14 and 21 days after the instillation of the substance. The mean individual scores were calculated within 3 scoring times (24, 48 and 72 hrs).
The mean score was 1.3 for corneal opacity, 1.0 for the iris lesion, 3.0 for chemosis and 2.0 for conjunctival erythema. While the effects on the conjunctivae (redness and chemosis) were fully reversible within 21 days, effects on the cornea and on the iris were irreversible over the 21 -day observation period.
Therefore, under the test conditions, Dermalcare MAP L-213/K induced irreversible damage to the rabbit eye and is classified as Eye Dam. 1 (H318) according to the criteria of the Regulation (EC) 1272/2008 (CLP) and as Xi, R41according to the criteria of the Directive 67/548/EEC.
Reference
Table 7.3.2/1: Irritant/corrosive response data at each observation time up to removal of animal from the test (21 days)
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0 |
0 |
2 |
2 |
24 h |
1 |
1 |
2 |
3 |
48 h |
1 |
1 |
2 |
3 |
72 h |
2 |
1 |
2 |
3 |
7 days |
2 |
1 |
1 |
1 |
14 days |
2 |
1 |
1 |
1 |
21 days |
2 |
1 |
0 |
0 |
Average 24h, 48h, 72h |
1.3 |
1.0 |
2.0 |
3.0 |
Reversibility*) |
n |
n |
c |
c |
Average time (day) for reversion |
- |
- |
21 |
21 |
*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible
OP: Scoring masked by marked corneal opacity
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The data available on two structural analogs of Dermalcare MAP L-213/S satisfy the irritation / corrosion endpoint requirements for an Annex VII dossier. The studies are screening tests but are scientifically acceptable and of good quality.
Justification for selection of skin irritation / corrosion endpoint:
No study selected because a weight of evidence approach was used based on data available for structural analogs of Dermalcare MAP L213/S (for justification of read-across between Dermalcare MAP L213S and its analogues, please refer to corresponding assessment report in Section 13).
Justification for selection of eye irritation endpoint:
Only one study available
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP2.
Self classification:
Dermalcare MAP L213/S is classified as Skin irr. 2 (H315) according to Regulation (EC) 1272/2008 (CLP) and as Xi; R38 according to Directive 67/548/EEC.
Dermalcare MAP L213/S is classified as Eye Dam. 1 (H318) according to Regulation (EC) 1272/2008 (CLP) and as Xi; R41 according to 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.
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