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EC number: 249-636-2 | CAS number: 29450-45-1
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07.08.2008 - 05.10.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Other in vivo data available. Study according to OECD 406 The Guinea pig maximization test (GPMT) was performed in the past for the purpose of other regulatory programs – crop protection regulations.
Test material
- Reference substance name:
- 2-ethylhexyl (4-chloro-2-methylphenoxy)acetate
- EC Number:
- 249-636-2
- EC Name:
- 2-ethylhexyl (4-chloro-2-methylphenoxy)acetate
- Cas Number:
- 29450-45-1
- Molecular formula:
- C17H25ClO3
- IUPAC Name:
- 2-ethylhexyl (4-chloro-2-methylphenoxy)acetate
- Reference substance name:
- (4-chloro-2-methylphenoxy)acetic acid
- EC Number:
- 202-360-6
- EC Name:
- (4-chloro-2-methylphenoxy)acetic acid
- Cas Number:
- 94-74-6
- Molecular formula:
- C9H9ClO3
- IUPAC Name:
- (4-chloro-2-methylphenoxy)acetic acid
- Test material form:
- liquid
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS AND HUSBANDRY
Species
Dunkin Hartley, Albino guinea pigs Hodowla zwierząt laboratoryjnych Ilkowice 41, 32-218 Slaboszow, Poland,
35 animals (Animal Delivery Protocol No. 20B/2008).
Starting Body Weight: 400-565 g.
Number and Sex:
20 males - treated group (Animals No. 1-20)
10 males - control group (Animals No. 21-30)
5 males - pilot study (Animals No. 31-35)
Housing and feeding:
Animals were housed in cages in groups of 5. The temperature of experimental animal room was 22±2°C with the relative humidity 40-70 %; lighting was artificial 12 h light/12hdark.
Conventional laboratory diet (TOP DOVO Dobra Voda, supplier) and drinking water with addition of ascorbic acid in concentration 0.05% were served ad libitum. The sanitation was made according to standard procedures.
Acclimation
19.8.2008 — 2.9.2008
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Topical Application: 10% MCPA 2-EH in Olive oil
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- No changes in behaviour and health of animals were observed after application of MCPA-2 EH. Significant differences of the body weight between control and treated group were not registered on the start and on the end of the study.
- Remarks on result:
- other: 72 hours after start of challenge application, which gives 48 hours after removing of the patch
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- no concetration of tested substance. Only vehicle used.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: 72 hours after start of challenge application, which gives 48 hours after removing of the patch
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- From 0.5 to 5.0% for intradermal injection. From 5.0 to 100.0 for topical application
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other:
- Remarks:
- Results from Pilot study
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Executive summary:
RESULTS AND DISCUSSION
The test substance does not mix with water, therefore it could not use Physiological saline or Aqua pro injectione as vehicle, as was stated in Study plan. Test substance was mixable with olive oil, which it was used as vehicle article.
No changes in behaviour and health of animals were observed after application of MCPA-2EH. Significant differences of the body weight between control and treated group were not registered on the start and on the end of the study.
Score of reaction for MCPA-2EH
observation
time
/ hours/
total
number
animalsnumber of positive tested
animalsscore of reaction
sensitisation
rate (%)0
1
2
3
4
48
20
5
15
2
3
0
0
25
Sensitisation response
Mild sensitiser (grade H )
Re-challenge was not realized because the well-defined reactions were observed.
There were observed very slight and well-defined erythema 24 and 48 hours after removing of
the patch. The oedema hasn't been observed. The reactions of test animals which exceed the most severe control reaction are presumed to be due to sensitization.
The calculated sensitisation potential of MCPA-2 EH is 25%.
Conslusions:
Topical application of 10% MCPA-2EH in Olive oil induced the sensitization rate 25 %. According to this value the product MCPA-2EH belongs to the group of "mild sensitizer"(II).
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