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EC number: 240-539-0 | CAS number: 16484-77-8
- 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:
- 17 March 1994 to 15 April 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:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-2-(4-chloro-2-methylphenoxy)propionic acid
- EC Number:
- 240-539-0
- EC Name:
- (R)-2-(4-chloro-2-methylphenoxy)propionic acid
- Cas Number:
- 16484-77-8
- Molecular formula:
- C10H11ClO3
- IUPAC Name:
- (R)-2-(4-chloro-2-methylphenoxy)propionic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- Beige powder
- Details on test material:
- - Storage conditions: The test material was stored in a well-closed, light-resistant container, at room temperature.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Rabbits were housed individually in plastic cages.
- Diet: Pelleted diet available ad libitum.
- Water: Tap water from the municipal water supply, filtered and softened was available ad libitum.
- Acclimation period: They were acclimatised to laboratory conditions for 26 days prior to treatment.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2 °C
- Humidity: 60 ± 15 °C
- Air changes: 15 air changes per hour (average, not monitored)
- Photoperiod: 12-hour light, 12-hour dark cycles
IN-LIFE DATES
- From: 17 March 1994
- To: 15 April 1994
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- Clipped with electric clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg of test material was applied to the right flank.
NEGATIVE CONTROL
- The left flank remained untreated and served as a control. - Duration of treatment / exposure:
- The test material was held in contact with the skin for a period of 4 hours.
- Observation period:
- The study was terminated on Day 4
- Number of animals:
- Three female rabbits were selected for the study.
- Details on study design:
- TEST SITE
- Area of exposure: The day before treatment, the dorsum and the flanks of each animal were closely clipped with electric clippers. Only animals with healthy intact skin at the time of treatment were used. The test material was applied to an area of skin of 6 cm^2 on the right flank of the animals. Approximately 1 mL of 0.9 % saline was used to moisten the test material to ensure good contact with the skin. The left flank remained untreated and served as a control.
- Type of wrap if used: The test material was covered by a hydrophilic gauze patch which was secured by a semi-occlusive hypoallergenic dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: The residual test material was gently removed with water.
- Time after start of exposure: At the end of the 4-hour period.
OBSERVATION TIME POINTS
Animals were checked for moribundity and mortality twice daily throughout the study. Animals were examined at least once daily for clinical signs. The cutaneous reactions were evaluated 1, 24, 48 and 72 hours after the removal of the dressings. As there were no signs of irritation after 72 hours, the study was terminated on Day 4.
At the end of the study period, animals were sacrificed without necropsy.
SCORING SYSTEM:
The skin reactions to treatment were evaluated according to the following scoring system:
Erythema and eschar formation
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well-defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0 = No oedema
1 = Very slight oedema (barely perceptible)
2 = Slight oedema (edges of area well defined by definite raising)
3 = Moderate oedema (raised approximately 1 millimetre)
4 = Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema and no oedema were observed at any time.
- Other effects:
- There were no mortalities during the study.
There were no clinical signs during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- Under the conditions of this study, the test material did not produce positive criteria in any rabbit and was considered non-irritant to rabbit skin.
- Executive summary:
The skin irritation potential of the test material was assessed in accordance with the standardised guideline OECD 404 under GLP conditions.
The potential of the test material to induce skin irritation/corrosion was assessed after a single semi-occlusive application for four hours in a group of three female rabbits. 500 mg of test material was applied to closely clipped skin. All animals were observed daily and the skin reactions were scored 1, 24, 48 and 72 hours after removal of the patches.
No erythema and no oedema were observed at any time. There were no mortalities during the study and no clinical signs.
Under the conditions of this study, the test material did not produce positive criteria in any rabbit and was considered non-irritant to rabbit skin.
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