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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Version / remarks:
- adopted May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Version / remarks:
- Revised Edition November 1984
- GLP compliance:
- yes
- Limit test:
- no
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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach/Riss
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 299 (284-323) g for males and 264 (246 -276) g for females
- Housing: housed singly in type DK III stainless steel wire cages
- Diet: ad libitum, ground Kliba maintenance diet rat/mouse/hamster, 343 meal
- Water: ad libitum
- Acclimation period: 9 days
DETAILS OF FOOD AND WATER QUALITY: The food and water used was assayed for chemical and microbiological contaminants.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12hours/12 hours
IN-LIFE DATES: From: To: July 19, 1993 to August 26, 1993
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: 50cm2, dorsal and dorsolateral parts of the trunk
- % coverage: 10%
- Type of wrap: 4 layers of absorbent gauze and an elastic dressing
- Time intervals for shavings or clipplings: at least twice once a week
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 6 hours
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of the test item in olive oil DAB 10 over 26 hours was confirmed by analysis. In addition, analysis was performed to verify the correctness of the concentrations of the test substance preparations. The content of the active ingredient was determined by combining the results of Chiral HPLC analysis and packed column GC analysis. The analysis of the test substance preparations in olive oil were determined by Reversed Phase HPLC (stability analysis in olive oil) and by HPLC with UV-Detection (concentration control analysis).
- Duration of treatment / exposure:
- 4 weeks (21 applications)
- Frequency of treatment:
- 5 x 6h/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- other: yes, solvent control: olive oil DAB 10
- Details on study design:
- Mecoprop-P 2-EHE was applied 5 days per week for 6 hours to the clipped intact dorsal skin (at least 10 % of the body surface area) of Wistar rats over a period of 4 weeks (21 applications) using a semi occlusive dressing.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day, before and after exposure
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice a day on weekdays and once on weekends
DERMAL IRRITATION: Yes
- Time schedule for examinations: recorded daily, about 30 min after removal of the dressing
BODY WEIGHT: Yes
- Time schedule for examinations: once every week
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day
HAEMATOLOGY: Yes
- Time schedule for collection of blood: taken in the morning
- Anesthetic used for blood collection: No
- Animals fasted: Yes
- How many animals: 5 animals per test group and sex
- Parameters: leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, clotting analysis
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: taken in the morning
- Animals fasted: Yes
- How many animals:5 animals per test group and sex (same as for hematology)
- Parameters checked: Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, serum-gamma-glutamyltransferase, sodium, potassium, chloride, inorganic phosphate, calcium, urea, creatinine, glucose, total bilirubin, total protein, albumin, globulins, triglycerides, cholesterol, and magnesium - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Statistics:
- For body weight non-parametric one-way analysis was performed using the Kruskal-Wallis test. If the resulting p-value was equal or less than 0.05, a pairwise comparison of each dose group with the control group was carried out. This comparison was performed via the Mann-Withney U-test for hypothesis of equal medians. Both tests were performed two-sided. For all parameters, except the differential blood counts, a non-parametric one-way analysis was performed using the Kruskal-Wallis test. If the resulting p-value was equal or less than 0.05, a pairwise comparison of each dose group with the control group was carried out. This comparison was performed via the MANN-WITHNEY U-test for the hypothesis of equal medians. Both tests were performed two-sided.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Incidence and types of clinical signs were not adversely affected by treatment.
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight gain in test animals was comparable with that seen in controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were some statistically significant inter-group differences in the results of the clinical pathology testing. These deviations are marginal, sporadic or incidental, inconsistent, when compared with the other sex, or lack dosage-relationship. Accordingly, these findings are considered to be of ne toxicological significance.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No substance-related findings
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
The stability of the test substance in olive oil DAB 10 over a time interval of 26 hours was verified by analysis. The concentration control analysis yielded 96.5% and 100% of the nominal content for the 1.5g/100 mL and 15g/100 mL samples, respectively.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL of MCPP-P 2-EHE for male and female rats after repeated dermal application for 4 weeks is 1000 mg/kg bw/day for systemic and local effects, the highest dose level investigated.
- Executive summary:
An OECD TG 410 study under GLP conditions was performed to assess the dermal toxicity after repeated application of MCPP-P 2-EHE on rat skin over a period of 4 weeks. The unchanged test item was applied on clipped skin in concentrations of 1000, 150 or 15 mg/kg bw/day to 5 male and 5 female rats per dose. The frequency of treatment was 5 days per week for 6 hours. The test substance did not produce local irritation. No substance-related change in hematology and clinical chemistry was observed. In the clinical examinations, no substance-induced changes could be observed in all test groups. No treatment-related significant difference in absolute or relative weight parameters and no treatment-related gross lesions or microscopic findings were observed. The NOAEL of MCPP-P 2-EHE in this study is 1000 mg/kg bw/day for systemic and local effects for male and female rats.
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