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EC number: 248-607-1 | CAS number: 27689-12-9
- 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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in compliance with OECD (1992), Swiss Procedures and Principles (1986), US FDA (1991), and Japanese Ministry of Health and Welfare Good Laboratory Practice principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Procrylat
- IUPAC Name:
- Procrylat
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Procrylat
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: >90%
- Purity test date: No data
- Lot/batch No.: P 2274001
- Expiration date of the lot/batch: July 1997
- Storage condition of test material: At room temperature away from direct sunlight
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
Birkendorferstrasse 65
D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Weight at study initiation:
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no. 75/97)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 March 1997 To: 20 March 1997
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- 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:
- 72 hours
- Number of animals:
- 3 (2 female, 1 male)
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The area of exposure was flushed with lukewarm tap water after 4 hours.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: No erythema or edema was observed in any animal at any time point.
- Irritant / corrosive response data:
- No erythema or edema was observed in any animal at any time point throughout the observation period.
- Other effects:
- No clinical signs of sytemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study (all scores were 0; PII = 0), the test article is not a dermal irritant.
- Executive summary:
The primary skin irritation potential of the test article (liquid, batch P2274001) was evaluated in New Zealand White rabbits. This study was conducted in accordance with Swiss GLP (1986), OECD GLP (1992), US FDA GLP 21CFR58, Japan MHLW (1988). The study design was based on Directive 92/69/EEC, B.4 (1992) and OECD 404 (1993). The test article was administered as received. Hair was clipped from the dorsal skin of three rabbits (1 male, 2 females). The test article (0.5 mL) was applied to a 6 cm2 area on the skin. Gauze was used to cover the site and create a semi-occlusive dressing. The dressing was secured around the abdomen with tape for a 4-hour exposure. Observations for skin irritation (erythema and edema) were recorded at 1, 24, 48 and 72 hours after unwrapping. The Primary Irritation Index (PII) was calculated. There were no abnormal clinical signs or changes in body weight. All erythema and edema scores were 0 throughout the study and the PII was 0. Based on the results of this study (all scores were 0; PII = 0), the test article is not a dermal irritant.
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