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EC number: 413-750-2 | CAS number: 171090-93-0 ANOX 1315; ANOX BF; DURAD AX 38
- 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
- Study period:
- January 28, 1992 to February 28, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Organization for Economic Cooperation and Development (OECD) Guidelines for testing of chemicals
(Section 4, Subpart 406, Paris 1981). - Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Available study pre-dates LLNA method and is performed in accordance with GLP to international recognised guidelines.
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Species and strain: Dunkin Hartley albino guinea pigs
Justification for the selection of the test system: Dunkin Hartley albino guinea pig is the generally recommended species by Health Authorities in experimental model for skin sensitization studies
Supplier: Charles River Italia S.p.A., Via Indipendenza, 11, 22050 Calco (Como)
Shipping slip no. 00684, dated January 24, 1992 (20 animals)
Shipping slip no. 08363, dated October 31, 1991 (6 animals, preliminary test)
Number:
26 animals
10 animals/group
6 animals for the preliminary test (performed on December 11, 1991)
Body weight (and age): between 370-433 grams at the start of the experiment (corresponding to 2-3 months old)
Sex: male
Acclimatization: five days. Animals were observed daily to ascertain their fitness for the study.
Housing: (room T12C)
2 or 3 animals/cage in air-conditioned room.
-temperature: 22°C 2 2
-ail- changes: about 20/hour filtered on HEPA 99.97%
-relative humidity: 55% + 10
-light: 12 hours cycle (7 a.m. - 7 p.m.)
-cage: wire cages (40.5x38.5x18h) with stainelss steel feeder.
The waste that drops through the wire bottom on a removable paper was periodically disposed of.
An automatic standby power supply was not brought into operation as the main supply did not fail.
Animal identification: by coloring different area of the ears. A computerized randomization program was adopted allocate the animals to groups.
Cage identification: by cage card giving indelible experiment number, start day, the group and the subgroup (1a, 1b; 2a, 2b) identification.
Diet: the animals were fed a breeder standard GLP diet -certificate coded 8 GP 22, produced by Charles River Italia's feed licensee Mucedola S.r.l., Settimo bfilanese.
The declared contents, on the label, on dry matter basis (moisture 12%), were:
crude protein 19%
crude fat 4%
crude fiber 14.5%
ash 7.5%
The diet was supplemented by the Producer with vitamins and trace elements. According to the analytical certificates provided by the Supplier, the contents of the batch of diet used in this study were within ± 5% of the declared values and contaminants were within the limits proposed by EPA-TSCA (44FR:44053-44093, July 26, 1979).
The animal feed, in compliance with RBM SOPS is analyzed twice a year for bacterial contamination.
The diet was available to the animals "ad libitum".
Water: from the municipal water main system. Water is filtered and distributed "ad libitum" to the animals by an automatic valve system.
Periodically drinking water is analyzed for microbiologic count, heavy metals, other contaminants (e.g. solvents, pesticides) and other chemical and physical characteristics.
The acceptable limits of quality of the drinking water are those defined in EEC Directive 80/778.
Contaminants that might interfere with the objectives of the study are not expected to be present in the diet or in the drinking water.
The analytical certificates of animal feed and water are filed at RBM premises.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 50% (0.5 ml)
- Day(s)/duration:
- Day 0/6 hours
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 25% (0.5 ml)
- Day(s)/duration:
- Day 0/6 hours
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 27/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals in test group
10 animal in negative control group - Details on study design:
- Test article dosage levels
As reported in the protocol the preliminary test was performed in order to select a non irritating test article concentration.
The test article was assayed by occlusive patch on two animals for each concentration.
Three doses undiluted, 50% and 25% were tested.
0.5 ml of each test article concentration was applied onto the skin with a closed patch.
24 hours after the administration, the patches were removed, the animals were observed up to 48 hours for reaction at the skin area of the patch application.
All three doses were well tolerated and therefore the test article undiluted was used in the sensitization test.
Test article formulates
The test article formulate was used undiluted.
Test description
Administration route: topical exposure by occlusive patch
Dose administered: the test article was used undiluted
Observation of clinical sign: daily, be cage
Bodyweight recording: pre-trial and weekly thereafter
Experimental group: 1 of 10 animals
Negative control group: 1 of 10 animals.
The animals of this group were treated only at day 28 with the test article closed patch as the product was tested undiluted.
Experiment design
Induction
Day -1: the animals of group 1 were clipped on the shoulder region in an area of about 6x6 cm with an electric clipper, before treatment.
Day 0: the animals clipped the day before were treated with the test article. 0.5 ml of the product was held on contact with the skin of the shoulder region by mean of an occlusive patch for 6 hrs.
Day 7 and 14: the 6 hrs closed-patch was repeated (see day 0).
Challenge
Day 27: in the animals of the experimental or negative control group one flank was clipped in an area of about 2x2 cm.
Day 28: the challenge test was identical to the occlusive patch test of the inductive phase, unless the patch was held in place for 24 hrs.
Day 29: the patch was removed, the area of challenge marked, and the skin reaction was read.
Day 30: a second reading was done.
Assessment of skin reactivity
Evaluation of skin reaction:
0 normal skin
1 slight erythema
2 moderate-intense erythema, slight edema
3 marked erythema and edema
The results were expressed in terms of incidence and severity of response:
incidence: the number of animals showing responses of 1 or greater at either 24 or 48 hrs divided by the number of animals tested;
severity: the sum of the test grades divided by the number of animals tested. - Challenge controls:
- the challenge test was identical to the occlusive patch test of the inductive phase
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- Not required
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Skin sensitisation test in guinea pigs (Buhler test)
Bodyweight (grams)
Group no. |
Guinea pig no. |
Days |
||||
-1 |
6 |
13 |
21 |
27 |
||
1 |
1 2 3 4 5 6 7 8 9 10 |
400 405 404 370 407 386 420 395 379 405 |
450 478 471 443 500 429 491 466 453 467 |
498 547 541 499 557 475 552 430 495 550 |
532 616 611 561 635 545 607 609 556 605 |
574 669 667 612 668 573 678 657 608 708 |
2 |
11 12 13 14 15 16 17 18 19 20 |
408 433 422 405 397 405 404 417 406 421 |
483 494 506 480 476 474 470 507 504 491 |
542 538 585 545 527 538 538 575 584 548 |
597 569 656 593 607 613 637 632 604 655 |
636 588 713 666 648 674 695 680 710 636 |
Skin sensitisation test in guinea pigs (Buhler test)
Experimental group No. 1
Substance: [ANOX BF]
|
Challenge |
|
Days |
Test article 29 |
Test article 30 |
Guinea pig no. |
|
|
1 2 3 4 5 6 7 8 9 10 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0: No reaction
1, 2, 3: skin reaction was assessed according to the scale described in the text. Animals showing reaction ≥ 1 were considered positive
No. of positive animals at the challenge: 0
Results: NEGATIVE
Skin sensitisation test in guinea pigs (Buhler test)
Experimental group No. 2
Substance: [ANOX BF]
|
Challenge |
|
Days |
Test article 29 |
Test article 30 |
Guinea pig no. |
|
|
11 12 13 14 15 16 17 18 19 20 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0: No reaction
No. of positive animals at the challenge: 0
Results: NOT IRRITANT
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitizing potential of the test article [ANOX BF] was assessed in guinea pigs using the Buhler test as described by Klecak.
No animal treated with the test article showed positive reaction at the challenge.
On the basis of these results, under the experimental conditions applied, [ANOX BF] did not appear to possess sensitizing capacity. - Executive summary:
The sensitizing potential of the test article [ANOX BF] was assessed in guinea pigs using the Buhler test as described by Klecak.
In the group treated with the test article no animals showed positive reaction at the challenge.
Under the experimental conditions applied, [ANOX BF] did not appear to possess sensitizing properties.
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