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EC number: 413-110-2 | CAS number: 135861-56-2
- 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:
- 5th March 1993 to 16th June 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies with restrictions. Information relating to the test animals, exposure and test system were not described in the main body of the report but were given in the protocol only.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Purity 97.3%
Batch No.: 9236-23
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS (information provided in study protocol)
- Source: E.S.D, Romans, 01400, Chatillon-sur-Chalaronne, FRANCE
- Age at study initiation: adult (about 3 months old)
- Weight at study initiation: 2.00 to 3.00 kg
- Housing: Animals individually housed in stainless steel cages (internal dimensions 500 x 600 x 400 mm).
- Diet (e.g. ad libitum): About 150 g/animal/day of pelleted complete rabbit diet (Diet reference 112 C - Usine d'Alimentation Rationnelle, Villemaisson, 91360 Epinay-sur-Orge, FRANCE).
- Water (e.g. ad libitum): Softened and filtered mains drinking water available ad libitum (via automatic system).
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS (information provided in study protocol)
- Temperature (°C): 19 ± 3 °C
- Humidity (%): minimum35%
- Air changes (per hr): minimum 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial)I12 hours dark
IN-LIFE DATES: Not specified
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Sterile Codex liquid paraffin
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.46 g
- Batch no. (if required): T 8810 B
- Purity: Not specified - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 6 animals
- Details on study design:
- TEST SITE (information provided in study protocol)
- Area of exposure: The test material is applied to the animal's skin, to an area about 6 cm2 and then covered with a Codex hydrophilic eight layer gauze pad, of the same surface.
- % coverage: Not specified
- Type of wrap if used: The test article will be applied under a semi-occlusive dressing composed of a gauze pad approximately 2.5 cm x 2.5 cm, maintained in contact with the skin with a perforated tape. This tape will be applied on a crimped gauze bandage which will fully cover the clipped area to avoid possible imitation reactions and be wrapped around the animal without blocking the respiratory and abdominal movements.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The bandages were removed and, if necessary, excess test article which had not penetrated was wiped away with a gauze pad moistened with pure plive oil. Readings were then carried out 1 hour later.
- Time after start of exposure: 4 h
SCORING SYSTEM: As specified in OECD Guideline 404 (1981)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.17
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.67
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other: Mean overall score for 24, 48 and 72 h.
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0
- Remarks:
- Mean overall score for 24, 48 and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal: All
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: Mean overall score for 24, 48 and 72 h.
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0
- Remarks:
- Mean overall score for 24, 48 and 72 h
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- None reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From the results obtained under the experimental conditions employed, application of the test article to the rabbit skin provoked a weak irritation but the effects were fully reversible by 72 hours after treatment.
- Executive summary:
The test material, Millad®3988, was evaluated for its acute primary cutaneous irritation and corrosivity potential in male rabbits. The results obtained under the experimental conditions employed demonstrated that application of this test article to the rabbit skin provoked a weak irritation (erythema) but the effects were fully reversible by 72 hours after treatment. No oedema was observed over the 72 hour post exposure period.
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