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EC number: 630-324-3 | CAS number: 861229-15-4
- 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:
- August 25, 1992 - September 1, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- EPA FIFRA Subdivision F Guideline 81-5 Primary dermal irritation, revised Edition November 1984
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate
- EC Number:
- 630-324-3
- Cas Number:
- 861229-15-4
- Molecular formula:
- C18H27ClO3
- IUPAC Name:
- 2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark
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: 10-14 weeks
- Weight at study initiation: 2.4 to 3.0 kg
- Housing:ndividually in plastic cages with perforated floors
- Diet: ad libitum, Standard laboratory diet SDS Stanrab
- Water: ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained at approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12/12
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:
- single treatment
- Observation period:
- 8 days
- Number of animals:
- six
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of 25mm2
- % coverage: 25 mm x 25 mm
- Type of wrap if used: gauze pad, covered with "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water ( 30°- 40°C)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- on Day 1 ( approximately 30 minutes after removal of the dressings)
- on Day 2, 3 and 4 (= 24h, 48h and 72h)
- additional observations were made on Days 5 to 8
SCORING SYSTEM:
- Method of calculation: Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
No erythema 0
Very slight erythrema (barely perceptible) 1
well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Very slight erythrema was observed in a single animal only immediately after the removal of the dressings. By Day 2 very slight to well-defined erythema with or without very slight to slight edema was seen in all animals. Very slight erythema accompanied by very slight edema was observed in all animals on Day 3. All dermal reactions had resolved in three animals by Day 4 and in a further animal by Day 5. In the remaining two rabbits very slight dermal reactions persisted up to and including Day 7.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Table 1: Dermal reactions observed after application of MCPP-P 2-EHE
Rabbit number (# animal) |
E = Erythema O= Oedema |
Day |
1* 2 3 4 5 6 7 8 |
||
1 (male) |
E O |
0 1 1 0 0 0 0 0 0 1 1 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 1 0 0 0 0 0 1 2 1 1 1 1 1 0 0 1 1 1 1 1 1 0 0 2 1 0 0 0 0 0 0 1 1 0 0 0 0 0 0 1 1 1 0 0 0 0 0 2 1 0 0 0 0 0 0 1 1 1 1 1 1 0 0 1 1 1 1 1 1 0 |
2 (male) |
E O |
|
3 (male) |
E O |
|
4 (male) |
E O |
|
5 (male) |
E O |
|
6 (male) |
E O |
*Approximately 30 min after removal of the dressing
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- MCPP-P 2-EHE showed no skin irritation potential.
- Executive summary:
A dermal skin irritation study to assess the skin irritation potential of MCPP-P 2-EHE was performed. The method followed was that described in EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic animals 81-5 Primary dermal irritation (Version 1984). Six rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for a maximum of eight days. A single semi-occlusive application of MCPP-P 2-EHE to intact skin for 4 hours elicited very slight to well-defined dermal reactions, while all reactions had resolved by day 8. The mean value for erythema was not higher than 1.3 and the mean value for edema was not higher then 1 (according Draize score).
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