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EC number: 800-838-4 | CAS number: 1384855-91-7
- 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:
- From 18 Jan, 1994 to and 21 Jan, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-Propenoic acid, reaction products with dipentaerythritol
- EC Number:
- 800-838-4
- Cas Number:
- 1384855-91-7
- Molecular formula:
- Molecular formula not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, reaction products with dipentaerythritol
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): SR399
- Physical state: Viscous liquid
- Purity: Not known to HRC
- Lot/batch No.: HYH1309
- Expiration date of the lot/batch: January 1995
- Storage condition of test material: Room temperature in the dark
- Date received: 14 December 1993
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: Approx 17 to 19 weeks
- Weight at study initiation: 3.7 to 4.0 kg
- Housing: Individually in plastic cages with perforated floors in Building R 14 Room 1.
- Diet: SDS Stanrab (P) Rabbit Diet ( ad libitum)
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70%
- Air changes: 19 air changes/h
- Photoperiod: 12 h of artificial Iight (0700 - 1900 h) in each 24 h period
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 d
- Number of animals:
- 3
- Details on study design:
- Approx 24 h prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approx 100 mm x 100 mm. A 0.5 mL amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact
skin site on each animal. Each treatment site was covered with "Elastoplast" elastic adhesive dressing for 4 h. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No adverse effects were observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No adverse effects were observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No adverse effects were observed.
- Irritant / corrosive response data:
- Very slight erythema was seen in all three animals on Days 1 and 2. The skin were normal on Day 3.
Any other information on results incl. tables
Dermal reactions observed after application of the test substance:
Rabbit number and sex |
E=Erythema O=Oedema |
Day |
|||
1 |
2 |
3 |
4 |
||
2945 (male) |
E O |
1 0 |
1 0 |
0 0 |
0 0 |
2946 (male) |
E O |
1 0 |
1 0 |
0 0 |
0 0 |
2947 (male) |
E O |
1 0 |
1 0 |
0 0 |
0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: EU CLP criteria not met
- Conclusions:
- Under the study conditions, the test substance was determined to be not irritating to the skin.
- Executive summary:
A study was conducted to determine the skin irritation potential of test substance, DPHA to rabbit according to EU Method B.4, in compliance with GLP. Three rabbits were administered a single dermal dose of 0.5 mL under semi-occlusive dressing for 4 h. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water to remove residual test substance. The treated area was blotted dry with absorbent paper. All animals were observed daily for signs of toxicity and ill health. Examinations of treated skin were made on Day 1 (60 mins after removal of dressing), and on Days 2, 3 and 4 (i.e., 24, 48 and 72 h after exposure). Dermal irritation was assessed using the numerical grading system. Very slight erythema was seen in all three animals on Days 1 and 2. Skin was normal on Day 3. Under the study conditions, the test substance was determined not to be irritating to the skin (Parcell, 1994).
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