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EC number: 635-156-4 | CAS number: 109293-98-3
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1998-04-07 to 1998-05-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted with a structural analogous read-across substance in compliance to GLP and according to current guidelines. Please refer to IUCLID section 13 for read-across justification.
- Qualifier:
- according to guideline
- Guideline:
- other: method of BUEHLER, E.V. (1965): Delayed Contact Hypersensitivity in the Guinea Pigs, Arch. Dermat. Vol. 91, pp. 171 -177
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- revised edition November 1984
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Commission Directive 96/54/EC of July 30,1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF AG
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals
- Weight at study initiation: 305 - 396 g
- Housing: 5 animals per cage, stainless steel wire mesh cages with plastic-coated grating
- Diet: Kliba Labordiät (Kaninchen-Meerschweinchen-Haltungsdiät) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 25°C
- Humidity: 30 - 70%.
- Air changes: Fully air-conditioned
- Photoperiod: 12 h light/ 12 h darkness - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1 % Tylose CB 30.000 in aqua bidest.
- Concentration / amount:
- The following concentrations for induction and challenge were selected on the basis of the pretests:
1st until 9th induction:
Test substance 60% in 1% Tylose CB 30.000 in aqua bidest.
Challenge:
Test substance 50% in 1% Tylose CB 30.000 in aqua bidest. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1 % Tylose CB 30.000 in aqua bidest.
- Concentration / amount:
- The following concentrations for induction and challenge were selected on the basis of the pretests:
1st until 9th induction:
Test substance 60% in 1% Tylose CB 30.000 in aqua bidest.
Challenge:
Test substance 50% in 1% Tylose CB 30.000 in aqua bidest. - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: Pretest
Three 6-hour percutaneous occlusive applications were performed (three applications per week).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 hours // 24 hours (reading), epicutaneous
- Test groups: All
- Control group: Yes control group 1+2 (vehicle - left flank anterior)
- Site: Anterior left flank
- Frequency of applications: Three applications per week; days 0 - 2, 7 -9 and 14 -16 on the same application area
- Duration: 3 weeks
- Concentrations: 60% in 1% Tylose CB 30.000 in aqua bidest.
B. CHALLENGE EXPOSURE
- No. of exposures: 1, epicutaneous
- Day(s) of challenge: 13 days after the ninth induction
- Exposure period: 6 hours
- Test groups: All
- Control group: Yes, (control group 1: formualtion - anterior right flank; vehicle - posterior right flank); control group 2 (vehicle- right flank posterior)
- Site: Anterior right flank
- Concentrations: 50% in 1% Tylose CB 30.000 in aqua bidest.
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch - Challenge controls:
- Yes, treated with the test substance formulation, additionally 1% Tylose CB 30.000 in aqua bidest. was applied as a vehicle control.
- Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde techn. 85 %
- Positive control results:
- A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.
The positive control with Alpha-Hexylcinnamaldehyde techn. 85% showed that the chosen guinea pig strain was able to detect sensitizing compounds under the laboratory conditions chosen. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 1
- Dose level:
- 50 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group 1. Dose level: 50 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group 1
- Dose level:
- 50 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group 1. Dose level: 50 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group 2 (vehicle)
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group 2 (vehicle). Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group 2 (vehicle)
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group 2 (vehicle). Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Reference
BODY WEIGHTS
The expected body weight gain was generally observed in the course of the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key study
A study was performed to assess the skin sensitisation potential of SAN 836H 86 SP 401 DP Formulation using the guinea pig. The method followed was that described in:
EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic Animals 81-6 Dermal sensitization study (Revised Edition November 1984).
Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:
Induction (epicutaneous): 50% w/v in Alembicol D
Challenge (epicutaneous): 50% w/v in Alembicol D
Twenty test and ten control guinea-pigs were used in this study.
In this study, SAN 836H 86 SP 401 DP Formulation did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in eighteen of the twenty test animals. A further one animal gave an inconclusive response and the remaining test animal gave a positive response.
Supporting study
The read-across test substance (free acid) was tested for its sensitizing effect on the skin of the guinea pig in the Modified BUEHLER Test with 9 induction treatments according to the method of BUEHLER, E.V. (1965).
The application of the main test was performed over three weeks.
All inductions (epicutaneous) were performed with 60% test substance preparations (highest applicable concentration). The first, second and third induction caused discrete or patchy erythema in 2 test group animals.
After the fourth until ninth induction no signs of skin irritation were observed in all test group animals. A challenge (epicutaneous) was performed 13 days after the last induction.
The animals showed no clinical signs and skin sensitizing effect.
The expected body weight gain was generally observed in the course of the study.
The control group animals, which were applied with 1% Tylose CB 30.000 in aqua bidest., did not show any skin reactions.
Based on the results of this study and applying the evaluation criteria it was concluded that the read- across test substance (free acid) does not have a sensitizing effect on the skin of the guinea pig in the Modified BUEHLER Test under the test conditions chosen.
In a further supporting study with the read across test substance (free acid) conducted according the EPA guideline the test substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the twenty test animals tested.
Thus, the substance was judged non-sensitizing.
Migrated from Short description of key information:
The test item and the read- across test substance (free acid of the registered substance) do not have a sensitizing effect on the skin of the guinea pigs in the BUEHLER Test under the test conditions chosen.
Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant study
Justification for classification or non-classification
Based on the data of the test substance and read-across substance Diflufenzopyr (free acid), the substance Diflufenzopyr sodium salt needs not be classified as a skin sensitiser according to the criteria of Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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