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EC number: 213-866-1 | CAS number: 1041-00-5
- 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, other
- Remarks:
- SKIN PHOTOALLERGENICITY
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Gunea Pig were treated with test substances and effects observed post epidermal challenge applications followed by UV-B and UV-A irradiation or followed by UV-A irradiation.
- GLP compliance:
- no
- Type of study:
- Draize test
Test material
- Reference substance name:
- 2,2'-vinylenebis[5-methylbenzoxazole]
- EC Number:
- 213-866-1
- EC Name:
- 2,2'-vinylenebis[5-methylbenzoxazole]
- Cas Number:
- 1041-00-5
- Molecular formula:
- C18H14N2O2
- IUPAC Name:
- 2,2'-vinylenebis[5-methylbenzoxazole]
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identity FAT 65004/F TE
Batch 15060201 (China)
Purity determined in this study
Appearance
Smell
yellowish powder, solid at 20°C
neutral
pH-Value pH-value of a soln. of 2% (w/w) = 6.90
Expiration date August 25th, 2020
Storage to be stored at room-temperature
Constituent 1
- Specific details on test material used for the study:
- Test material: FAT 65004/C
Identification: Uvitex SK (DCT No. 90043)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The test was performed on 10 male and 10 female guinea pigs per group weighing between 270 - 370 g (Approx. 10 weeks old). The animals were housed individually in Macrolon cages (type 3) , assigned to the different groups by means of random numbers generated by the random number generator incorporated in the Hewlett-Packard desk computer, identified with individual ear tags, kept at a constant room temperature of 20±1 C°, at a relative humidity of 55 ±5 % and on a 14 hours
light cycle day. The animals received ad libitum standard guinea pigs pellets - NAFAG No. 830, Gossau SG - supplemented with fresh carrots and fresh water.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: DAE433
- Concentration / amount:
- 0.1 % suspension of FAT 65004/C in 80 % DAE433
- Day(s)/duration:
- 4 Times a week for three weeks the animals were treated
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: DAE433
- Concentration / amount:
- 0.1 % suspension of FAT 65004/C in 80 % DAE433
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: DAE433
- Concentration / amount:
- 0.1 % suspension of FAT 65'004/C in 80 % DAE433
- Day(s)/duration:
- 3
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 male and 10 female
- Details on study design:
- Method:
Induction:
4 days before starting the induction, the animals were shaven on the neck and chemically depilated. During the whole induction period the animals were only shaven (Aesculap , 1/20 mm). 4 Times a week for three weeks the animals were treated by epidermal open exposure with a 0.1 % suspension of FAT 65004/C in 80 % DAE433 (0.1 ml per application; 2x2 cm application area on the animals' neck).
One hour after application the animals were irradiate for 14 minutes during the first induction week (UV-A, visible), 10 minutes during the second and third week (UV-B, UV-A, visible).
During the irradiation process the animals were immobilized in a special animal holder. In order to protect the skin surrounding of the irradiated area, this part was covered with a lightproof bandage.
24 hours after each of the first four induction applications, the skin reactions were evaluated according the Draize Scoring Scale. The reactions during the second and third induction week were not recorded.
A total of 4 adjuvant injections were made to the four corners of the application site on Monday and Wednesday of the second and third induction week (0.1 ml suspension of adjuvant complete
Freund and physiological saline per injection).
Challenge I:
12 days after the last induction irradiation, the animals were shaven on the back and the skin was chemically depilated (5 min.). 4 days later the animals were treated by epidermal open exposure for three days as during the induction period. One hour after each application the animals were irradiated for 7 minutes with a sub-erythematogenic dose of UV-B, UV-A and visible light (lamp filtered with Schott filter WG 280,3 mm).
Challenge II:
A second challenge was done after a test period of 14 days. The substance was applied again three times on the shaven skin of the animals back. The test site was irradiated after each application for 15 minutes with a sub-erythematogenic dose of UV-A and visible light (lamp filtered with Schott WG 320, 3 mm).
24 hours after each application of both challenges, the skin reactions were evaluated according the Draize Scoring Scale. Every animal with one or more score values higher at the end of the two challenge periods than that obtained at the end of the first induction week was termed positive. The number of positive animals in the test group was compared with the number of animals in the control group treated with the vehicle alone. - Challenge controls:
- DAE4 33 control
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The individual erythema reactions were evaluated evaluated 24 hours after the last irradiation of either the induction or challenge I and challenge II periods.
Only one animal of the last group showed a reaction at the end of challenge period II. One animal (No. 863) died during the rest period after the induction procedure, unrelated to the treatment.
On the basis of these results, a photoallergenic potential of FAT 65 004/C in guinea-pigs can be excluded.
RESULTS:
No of positive animals/ No of treated animals | |
Challenge I DAE433 Control group FAT65004/C |
0/20 0/19 |
Challenge II DAE433 Control group FAT65004/C |
0/20 1/19 |
Individual erythema reaction score 24 hours after the last irradiation of the induction, challenge I and challenge II:
Control Group | Animal number | |||||||||||||||||||
DAE433 | 821 | 822 | 823 | 824 | 825 | 826 | 827 | 828 | 829 | 830 | 831 | 832 | 833 | 834 | 835 | 836 | 837 | 838 | 839 | 840 |
Induction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Challenge I | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Challenge II | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | Animal number | |||||||||||||||||||
FAT 65004/C | 861 | 862 | 863 | 864 | 865 | 866 | 867 | 868 | 869 | 870 | 871 | 872 | 873 | 874 | 875 | 876 | 877 | 878 | 879 | 880 |
Induction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Challenge I | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Challenge II | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of these results, a photoallergenic potential of FAT 65004/C in guinea-pigs can be excluded.
- Executive summary:
Under the experimental condition employed, no differences between the test group and the vehicle-treated controls were seen, after epidermal challenge applications either followed by UV-B and UV-A
irradiation or followed by UV-A irradiation alone.
FAT 65004/C was found to be devoid of a photoallergenic potential in albino guinea-pigs.
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