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EC number: 614-283-9 | CAS number: 68127-59-3
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-01 to 1984-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no justification for vehicle choice; pretest results not reported; lauryl sulphate pretreatment of application site omitted; no validity check (positive controls) reported; weight development not reported; purity of the test material not reported.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed at a time prior to the acceptance of the LLNA-test as a valid measure for skin sensitisation (OECD guideleine LLNA, TG 429 adopted in 2002).
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: 303 - 418 g
- Housing: individually in stainless steel cages, 370 x 320 x 200 mm; floor and back: 12 mm square mesh, door: Makrolon (polycarbonate); 2 animals per cage, separated by a solid metal partition (equal compartments)
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 18°C, constantly recorded
- Humidity (%): 40 - 45% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: not reported - Route:
- intradermal and epicutaneous
- Vehicle:
- other: dimethylformamide (DMF); 3% DMF / corn oil mixture
- Concentration / amount:
- Intradermal pretest (sighting): up to 5% (w/v) in a mixture of DMF and corn oil
Topical (epicutaneous) pretest (sighting, for induction and challenge): suspensions of the test substance in DMF, 3 doses, concentrations not stated
Intradermal induction: 1% w/v suspension in a 3% DMF / corn oil mixture; 1% w/v suspension in a 1:1 preparation of Freund's Complete Adjuvant (FCA) plus 3% DMF / corn oil mixture
Epicutaneous induction: 75% (w/v) suspension in DMF
Challenge (epicutaneous): 10% (w/v) suspension in DMF
(In the report, all preparations were variantly described as suspensions or solutions, the former appears more likely) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: dimethylformamide (DMF); 3% DMF / corn oil mixture
- Concentration / amount:
- Intradermal pretest (sighting): up to 5% (w/v) in a mixture of DMF and corn oil
Topical (epicutaneous) pretest (sighting, for induction and challenge): suspensions of the test substance in DMF, 3 doses, concentrations not stated
Intradermal induction: 1% w/v suspension in a 3% DMF / corn oil mixture; 1% w/v suspension in a 1:1 preparation of Freund's Complete Adjuvant (FCA) plus 3% DMF / corn oil mixture
Epicutaneous induction: 75% (w/v) suspension in DMF
Challenge (epicutaneous): 10% (w/v) suspension in DMF
(In the report, all preparations were variantly described as suspensions or solutions, the former appears more likely) - No. of animals per dose:
- Intradermal induction pretest: 2 animals / dose, 3 doses
Topical (epicutaneous) induction pretest: 2 animals / dose, 3 doses
Topical (epicutaneous) challenge pretest: 2 animals / dose, 3 doses
Main test: 20 animals
Controls to main test: 10 animals - Details on study design:
- RANGE FINDING TESTS:
Formulation: No rationale is given for the choice of 3% DMF in corn oil as the appropriate vehicle
Tolerability intradermal: Injection of the test substance in DMF / corn oil (3 concentrations of the test substance, up to 5% w/v) to the clipped skin of 2 animals each, to determine the highest well-tolerated concentration
Tolerability topical induction: Application of the test substance in DMF (3 concentrations, not specified) to the clipped skin of 2 animals each, to determine the highest concentration not producing excessive inflammation
Tolerability topical challenge: Application of the test substance in DMF (3 concentrations, not specified) to the clipped skin of 2 animals each that had been injected with FCA at least 14 days in advance, to determine the highest concentration not producing excessive inflammation or irritation after FCA pretreatment
MAIN STUDY
A. INTRADERMAL INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: -
- Test groups: 1 group of 20 animals
- Control group: 1 group of 10 animals
- Site: 50 x 50 mm clipped area on scapular region, one row of three injections on either side of the mid-line
- Injections (0.1 mL each): i) FCA plus corn oil, ratio 1:1; ii) 1% suspension of the test substance in a 3% DMF / corn oil mixture; iii) 1% suspension of the test substance in a 1:1 preparation of FCA plus 3% DMF / corn oil mixture
- Injections of control animals (0.1 mL each): i) FCA plus corn oil, ratio 1:1; ii) corn oil ; iii) FCA plus corn oil, ratio 1:1
- Frequency of applications: 1
- Duration: 1 week
- Concentrations: 1% test substance in the media described above
B. TOPICAL (EPICUTANEOUS) INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test / control groups: same animals as above
- Site: Same area on scapular region, clipped again (no pre-tretment with sodium lauryl sulphate to create a local irritation)
- Application: 0.25 mL of a suspension of the test substance in DMF applied to a filter paper (40 x 20 mm) held in place by surgical tape (80 x 40 mm). Tape covered by adhesive bandage approx. 200-300 mm x 50 mm, which was wrapped (once only) by self-adhesive PVC tape No 92 (300 x 25 mm)
- Application of control animals: Same as above, with DMF only
- Frequency of applications: 1
- Duration: 2 weeks
- Concentrations: 75% test substance in DMF
C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 21, 3 weeks after intracutaneous and 2 weeks after topical induction
- Exposure period: 24 hours
- Site: areas approx. 150 x 50 mm on both flanks, clipped free of hair
- Test groups: 0.05 mL of a 10 % suspension of the test substance in DMF applied to a filter paper (10 x 15 mm) stitched to a piece of 0.5 mm rubber sheeting (120 x 50 mm approx.). Occlusive dressing covered by adhesive bandage approx. 250 x 75 mm, so that the test substance touched a previously unexposed site on the left flank. Secured by self-adhesive PVC tape (300 x 25 mm).
- Control group: Same as above
- Concentration: 10% w/v suspension in DMF
- Evaluation (hr after challenge): 24 and 48 hours after removal of the occlusive dressing (48 and 72 hours from the start of challenge)
- Quantification: grading of erythematous reactions using a 4-point scale, similar to that of Magnusson & Kligman; percentage of responding control animals subtracted from percentage of responding test animals to calculate the net response. - Challenge controls:
- None reported
- Positive control substance(s):
- not specified
- Remarks:
- Reliability check of the method: not reported
- Positive control results:
- None reported
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05 mL of a 10% w/v suspension in DMF
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- faint erythema, grade 1: scattered diffuse redness
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05 mL of a 10% w/v suspension in DMF. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: faint erythema, grade 1: scattered diffuse redness.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05 mL of a 10% w/v suspension in DMF
- 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: 0.05 mL of a 10% w/v suspension in DMF. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05 mL of a 10% w/v suspension in DMF
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema, grade 1: scattered diffuse redness
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.05 mL of a 10% w/v suspension in DMF. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema, grade 1: scattered diffuse redness.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05 mL of a 10% w/v suspension in DMF
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema, grade 1, doubtful
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.05 mL of a 10% w/v suspension in DMF. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema, grade 1, doubtful.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was classified not to be a sensitiser to guinea pig skin under the conditions of the assay. The study report is relevant, reliable witht restrictions and adequate for risk assessment, classification and labeling.
- Executive summary:
The sensitising properties of the test material (a powder) were assessed according to a method similar to OECD 406 in 30 female Dunkin Hartley albino guinea pigs in a Magnusson-Kligman guinea-pig maximisation test. For intradermal induction, the test substance (1% w/v in DMF / corn oil) was injected with and without Freund’s complete adjuvant. Topical induction (7 days later) was performed with a 75% w/v suspension of the test material in DMF applied under an occlusive dressing for 48 hours. As a challenge (on day 21 of the test), 0.05 mL of a 10% w/v suspension in DMF were applied for 24 hours under an occlusive dressing. 24 and 48 hours after the removal of the dressing, erythema scores were read and the number of responding animals recorded.
The study report has certain shortcomings (reliability checks, results of pilot study, and body weights not reported). The omission of the lauryl sulphate pretreatment at the topical induction site may be explained by the fact that the test substance was found to be a slight irritant to rabbit skin (same report).
Twenty-four hours after the removal of the challenge application, faint erythema was observed in 2 / 20 animals in the treated group, and in 1 / 10 animals in the control group, which results in a net sensitisation response of 0%. After 48 hours, a faint (doubtful) erythema was only seen in one control animal.
The results indicate the test material as not being sensitiser to guinea pig skin.
Reference
Two out of twenty animals of the test group (nos. 101 and 103) showed faint erythema (grade 1, scattered, mild redness) after 24 hours, which was no longer visible after 48 hours.
One out of ten control animals (no 128) had grade 1 erythema after 24 hours and 48 hours, the latter reading was marked as "doubtful".
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Only a single skin sensitisation study (guinea-pig maximisation test, Magnusson & Kligman) conducted under a GLP according to a method similar to guideline OECD 406 (with minor deviations) is available (Southwood 1984a). The study is considered to be relevant, reliable with restrictions and adequate for the purposes of risk assessment, classification and labelling.
The guinea-pig maximisation test showed that the test substance is not a sensitiser to guinea pig skin: 2 / 20 induced animals showed faint erythema upon challenge, compared with 1 / 10 in the control. This results in a calculated net sensitisation response of 0%.
Migrated from Short description of key information:
Skin sensitisation, guinea pig: not sensitising, method similar to OECD 406, Southwood 1984a
Justification for selection of skin sensitisation endpoint:
only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No experimental information for respiratory sensitisation is available
Migrated from Short description of key information:
No data available for respiratory sensitisation.
Justification for classification or non-classification
The results of the study in skin sensitization on guinea pig indicate the substance is not a skin sensitizer. As a result the substance does not meet the criteria for classification according to Directive 2001/59/EC, Annex VI, 3.2.7.2 and according to Regulation (EC) No. 1272/2008, Part 3, 3.4.2.2.
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