Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- 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.
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 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
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 / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies