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Diss Factsheets
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EC number: 479-100-5 | CAS number: 577705-90-9
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- January 23 - February 22, 1990
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD GLP in the testing of chemicals [C(81)30 final], regulation enforced by the Italian Health Authority (D.M. dated June 26, 1986 as published in G.U. no.198, August 27, 1986 and D.M.dated April 28, 1988 as published in G.U. no.107, May 9, 1988.
- GLP compliance:
- not specified
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description: white powder
Batch: 14334/56
Purity: > 99%
Storage conditions: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Body weight: between 432 - 570 grams at the start of the experimet (corresponding to 2-3 months old)
Acclimatation: at least five days. Animals were observed daily to ascertain their fitness for the study.
Housing: 5 animals/cage in air conditioned room. Temperature: 22°C+/-2; air changes: about 12 h; relative humidity: 60% +/-2; light: 12 hours cycle
Animal identification: by coloring different area of the ears. A computerized randomization program was adopted to allocate the animals to groups.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol.
- Concentration / amount:
- 175 mg/animal for each application.
The test article was diluted w/v in ethanol to obtain 35% test article concentration.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol.
- Concentration / amount:
- 175 mg/animal for each application.
The test article was diluted w/v in ethanol to obtain 35% test article concentration.
- No. of animals per dose:
- 23 animals
10 animals/group
3 animals for the preliminary test
Results and discussion
Any other information on results incl. tables
Skin sensitization test in guinea pigs (Buhler test)
Body weight (grams)
Group n. |
Guinea pig n. |
Days |
|||
0 |
7 |
14 |
28 |
||
1 |
1 |
488 |
522 |
558 |
586 |
|
2 |
458 |
489 |
541 |
629 |
|
3 |
570 |
616 |
687 |
623 |
|
4 |
515 |
559 |
615 |
609 |
|
5 |
478 |
522 |
583 |
675 |
|
6 |
520 |
535 |
589 |
585 |
|
7 |
482 |
488 |
524 |
657 |
|
8 |
525 |
565 |
627 |
634 |
|
9 |
488 |
518 |
543 |
722 |
|
10 |
501 |
528 |
575 |
651 |
|
|
|
|
|
|
2 |
11 |
480 |
523 |
546 |
670 |
|
12 |
432 |
501 |
548 |
649 |
|
13 |
510 |
557 |
618 |
665 |
|
14 |
513 |
551 |
600 |
706 |
|
15 |
432 |
470 |
482 |
498 |
|
16 |
459 |
518 |
544 |
620 |
|
17 |
550 |
607 |
662 |
770 |
|
18 |
496 |
532 |
559 |
620 |
|
19 |
482 |
525 |
591 |
681 |
|
20 |
525 |
558 |
610 |
713 |
Skin sensitization test in guinea pigs (Buhler test)
Experimental group N. 1
|
Challenge |
|||
|
Test article |
Vehicle |
Test article |
Vehicle |
Days |
29 |
30 |
||
Guinea pig n. |
|
|
|
|
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
9 |
0 |
0 |
0.5 |
0 |
10 |
0 |
0 |
0 |
0 |
0: No reaction
Animals showing reaction > 1 were considered positive. N. of positive animals at the challenge: 0
Results: NEGATIVE
Skin sensitization test in guinea pigs (Buhler test)
Experimental group N. 2
Substance: ethanol
|
Challenge |
|||
|
Test article |
Vehicle |
Test article |
Vehicle |
Days |
29 |
30 |
||
Guinea pig n. |
|
|
|
|
11 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
15 |
0 |
0 |
0 |
0 |
16 |
0 |
0 |
0 |
0 |
17 |
0 |
0 |
0 |
0 |
18 |
0 |
0 |
0 |
0 |
19 |
0 |
0 |
0 |
0 |
20 |
0 |
0 |
0 |
0 |
0: No reaction
Animals showing reaction > 1 were considered positive. N. of positive animals at the challenge: 0
Results: NEGATIVE
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The sensitizing potential of the test article was assessed in guinea pigs using the Buhler test. No animal trated with the test article showed positive reaction at the challenge.
On the basis of these results, under the experimental conditions applied, the test item did not appear to possess sensitizing capacity.
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