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Diss Factsheets
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EC number: 458-430-3 | 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:
- 13/01/1999 to 02/02/1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK.
- Age at study initiation: 12-16 weeks.
- Weight at study initiation: 2.77-3.17 kg.
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 44-70
- Air changes (per hr): Approximately 15.
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- 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:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Three suitable test sites selected on the backs of the rabbits. A 2.5 x 2.5 cm cotton gauze was used.
- % coverage: No data
- Type of wrap if used: Patch was secured with a strip of surgical adhesive tape and covered with an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated spirits.
- Time after start of exposure: 4 hours.
SCORING SYSTEM: Draize, 1977
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- erythema
- Remarks on result:
- other: Reduced fur growth at 14 days.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- erythema
- Remarks on result:
- other: Reduced fur growth and mild desquamation at 14 days.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- erythema
- Remarks on result:
- other: Reduced fur growth and mild desquamation at 14 days.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- edema
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- edema
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- edema
- Irritant / corrosive response data:
- Loss of skin flexibility and/or loss of skin elasticity were noted at all of the treated skin sites at the 72-hour observation. Crust formation, which precluded the evaluation of erythema and oedema, was noted at all of the treated sites at the 7-day observation. Slight desquamation or reduced regrowth of fur were noted at all of the treated skin sites at the 14-day observation.
- Other effects:
- At 7 days following exposure the erythema and oedema could not be assessed due to 'crust formation'. At 14 days erythema and oedema had reversed but there was reduced fur growth in 3/3 animals and mild desquamation in 2/3 animals.
Any other information on results incl. tables
Table 1 Skin irritation results
Skin reaction | Reading (hours) | Individual scores | ||
Male 1 | Male 2 | Female | ||
24 | 2 | 2 | 2 | |
Erythema/eschar formation | 48 | 2 | 2 | 2 |
72 | 2 | 2 | 2 | |
Total | 6 | 6 | 6 | |
Mean score | 2.0 | 2.0 | 2.0 | |
24 | 2 | 3 | 2 | |
Oedema | 48 | 2 | 2 | 2 |
72 | 2 | 2 | 2 | |
Total | 6 | 7 | 6 | |
Mean score | 2.0 | 2.3 | 2.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- Based on a skin irritation study conducted to OECD 404 and in compliance with GLP, the test substance was irritating to the skin of rabbits. Erythema were observed in all three animals tested, with mean 24-72 hour scores of 2 in all three animals tested. For oedema the mean 24-72 hour score was 2 in 2/3 animals and 2.3 in 1/3 animals tested. At 7 days following exposure the erythema and oedema could not be assessed due to 'crust formation'. At 14 days erythema and oedema had reversed but there was reduced fur growth in 3/3 animals and mild desquamation in 2/3 animals. Therefore due to the reduced fur growth and desquamation at the end of the observation period (14 days), the test substance is concluded to be irritating to skin.
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.
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