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EC number: 464-520-3 | CAS number: 189813-45-4
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Remarks:
- BASF AG, Experimental Toxicology and Ecology
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): 520 F-Chlormethyloximether (Stufe 9 der BAS 520 FSynthese)
- Physical state: solid, crystalline / grey
- Analytical purity: 98.3 g/100 g
- Lot/batch No.: 29388-136
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc: DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 347-400 g
- Housing: 5 per cage
- Diet (e.g. ad libitum): Kliba Labordiet
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days before the beginning of the study in the laboratory for dermal toxicity
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Induction (intradermal injection):
2 injections each of 0.1 ml of a test substance formulation (5 % in olive oil),
Induction (epicutaneous): 1 ml of the test substance formulation (50 % in olive oil),
Challenge: 0.5 ml of the test substance formulation (25 % in olive oil)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction (intradermal injection):
2 injections each of 0.1 ml of a test substance formulation (5 % in olive oil),
Induction (epicutaneous): 1 ml of the test substance formulation (50 % in olive oil),
Challenge: 0.5 ml of the test substance formulation (25 % in olive oil)
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in control group: 5 - Details on study design:
- RANGE FINDING TESTS: Dose rate for the main test were determined in the pretests. In the intradermal pretest, 6 intradermal injections were given in the shoulder of 2 per animals as follows:
- front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1: 1,
- middle row: 2 injections each of 0.1 ml of a test substance formulation in olive oil at 5% concentration,
- back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCI-solution (1: 1) with test substance at the 5 % concentration.
Readings were observed after 24 h. In front and back row, intense erythema and swelling were observed. In the middle row, moderate swelling was observed.
In the Epicutaneous Pretest, animals pretreated with Freund's adjuvant / 0.9% aqueous NaCI-solution (1 :1) each, in the same manner as intradermal pretest referring front row and back row without test substance 4 weeks prior to the application of the test substance were used. 2 x 2 cm gauze patches containing 0.5 ml of the test substance formulations at concentrations of 5, 10, 25 and 50% were applied to the skin of the flanks for 2 x 24 hours under an occlusive dressing. Readings were taken 24 h and 48 h after the beginning of application. 24 h after 1st epicutaneous application, discrete or patchy erythema were observed in both animals at concentrations 5-25 % and in one animals at 50% concentration. In the other animal at 50% concentration, moderate and confluent erythema was observed. 48 h after 1st application, both animals with concentrations 5-25 % recovered. No recovery was observed at 50% concentration. 24 h after 2nd application, similar results were observed as after 1st application at concentrations 5-25 %. At 50% concentration, both animals showed moderate and confluent erythema with were reduced to discrete or patchy erythema after 48 h.
MAIN STUDY
A. INDUCTION EXPOSURE- Intradermal
- No. of exposures: 6
- Test groups: as follows:
1) 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1: 1,
2) 2 injections each of 0.1 ml of a test substance formulation in olive oil at 5% concentration,
3) 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCI-solution (1: 1) with test substance at 5% concentration.
- Control group: same as in test group but the test substance was omitted.
- Site: shoulder
- Concentrations: 5%
INDUCTION EXPOSURE- Epicutaneous, 1 week after intradermal induction
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: under occlusive condition
- Control group: same as in test group but the test substance was omitted.
- Site: shoulder
- Frequency of applications: 1
- Duration: 48 h
- Concentrations: 50 %
B. CHALLENGE EXPOSURE
- No. of exposures: 2 (second challenge 7 days after 1st challenge)
- Day(s) of challenge: first challenge was performed 14 days after the epicutaneous induction. A second challenge was carried out one week after the first one
- Exposure period: 24 h
- Test groups: Epicutaneous under occlusive condition
- Control group: same as in test group but the test substance was omitted.
- Site: right flank anterior for test substance and left flank anterior for the vehicle
- Evaluation (hr after challenge): 24 and 48 h afterthe removal of the patch - Challenge controls:
- yes, vehicle control group (n=5)
- Positive control substance(s):
- yes
- Remarks:
- see free text
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 2.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Signs of irritation during induction:
The intradermal induction caused moderate and
confluent erythema in all test and control animals. The epicutaneous
induction led to incrustation, partially open (caused by the intradermal
induction), moderate and confluent erythema in addition to swelling in
all test group and control animals.
Evidence of sensitisation of each challenge concentration:
After the challenges with a 25% test substance preparation in olive
oil discrete or patchy erythema to moderate and confluent erythema,
swelling and scaling could be observed
in some test group animals. While the skin reactions
observed in two test group animals after the
first challenge were reproducible by the 2nd challenge, the third animal
with reactions after first challenge did not show any skin effects
after 2nd challenge. However,
another animal was observed with skin effects
after the 2nd challenge in the test group.
Based on the results of this study, the test substance has a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen and can be classified as skin sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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