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EC number: 457-320-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-21 to 2002-06-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- red viscous liquid
batch number: MRD-02-375
expiry date: 30-April-2007
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Denver PA, USA
- Age at study initiation: 2 males: 12-13 weeks; 1 male: 19-20 weeks
- Weight at study initiation: 2.34 to 3.39 kg
- Housing: singly housed in suspended stainless steel with wire mesh cages
- Diet (e.g. ad libitum): PMI Feeds, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days (2 males); 50 days (1 male)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 to 22.2
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 2002-05-21 To:2002-06-04
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: closely clipped at 48 and 24 h prior to dosing
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.54 cm x 2.54 cm
- % coverage: no data
- Type of wrap if used: gauze patch held in place by non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with peanut oil/paper towels
- Time after start of exposure: 4 hours
SCORING SYSTEM: modified Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.2
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Animal #1: at 72 h - erythema grade 4 and oedema grade 1 with blanching of test site
at 14 d - erythema grade 1 with desquamation
Animal #2: at 72 h - erythema grade 2 and oedema grade 1
at 14 d - no lesions
Animal #3: at 72 h - erythema grade 2 and oedema grade 1
at 14 d - desquamation
- Other effects:
- Blanching, eschar, cracking, exfoliation and desquamation
Any other information on results incl. tables
All animals survived to the end of the study and gained in weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study conducted according to OECD guideline 404, semi-occluded exposure to undiluted test substance (0.5 ml) for 4 hours was moderately irritating to the skin of rabbits. The mean score for erythema was >2.3 in only 1/3 animals; therefore, the test material would not be classified as a skin irritant according to EU CLP criterion 1. However, as quite pronounced effects were seen in one animal, it is concluded that in accordance with EU CLP criterion 3, a precautionary classification as a skin irritant is warranted.
- Executive summary:
In a GLP study conducted according to OECD guideline 404, the dermal irritation potential of the substance was evaluated in three male rabbits. 0.5 ml of the undiluted test material was applied to an area of closely clipped skin under a semi-occlusive patch and removed after 4 hours by wiping with peanut oil/paper towel. Animals were observed twice daily for viability (once at weekends) and clinical observations were made daily during the study. Body weights were recorded on days 0 and 14. Dermal responses were evaluated 1, 24, 48 and 72 hours after patch removal and on days 7, 10 and 14 using a modified Draize scoring system in which a maximum score of 4 is possible for erthyema and for oedema.
All animals survived to day 14 and gained body weight. Dermal irritation was seen within 1 hour of test substance removal, with all animals having grade 1 erythema and grade 1 oedema. Erythema increased, reaching grade 4 in one animal and grade 2 in the others, by 72 hours. No increase in oedema score was seen over this period. Both erythema and oedema scores decreased during the rest of the study, being fully reversible in 2/3 animals and with one animal having a slight erythema (grade 1) at day 14. Other lesions seen during the study were skin blanching in one animal at 48 and 72 hours only, eschar in one animal and cracking in two animals on day 7 only, exfoliation in two animals on day 10 only, and desquamation in two animals on day 14 only.
Mean erythema scores for 24, 48 and 72 hours were 3.3, 1.7 and 1.7, respectively, and mean oedema scores were 1 at each of the three timepoints. Since a mean erythema score of >2.3 was only seen in one of the three animals, the test material does not meet the first criterion for classification as a skin irritant according to EU CLP criteria. However, as quite pronounced effects were seen in one animal, it is concluded that in accordance with EU CLP criterion 3, a precautionary classification as a skin irritant is warranted.
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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