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EC number: 296-120-8 | CAS number: 92257-31-3
- 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
A reliable skin sensitising assay performed using Guinea pigs
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:
- 6-23-1989 to 8-4-1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similar to OECD 406 guideline study. The study was performed in accordance with GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The procedure used was based on that of Buehler (Buehler, 1965; Ritz and Buehler, 1980). The study was conducted according to the general conditions of the protocol and specifically as designated in the Project Instruction Sheet and Supplemental Instructions, as applicable. As such, it satisfies the criteria established by the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substance Control Act (40 CFR), and the OECD Guidelines.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study performed prior to the establishement of the LLNA protocol as an OECD guideline
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST SYSTEM JUSTIFICATION:
The guinea pig has historically been used for this test and allows the data to be compared to that of other materials.
TEST ANIMALS:
Young adult, male and female Hartley guinea pigs of a size to fit the restraining device from a U.S.D.A. approved supplier will be used. The animals will be of a size to fit the restrainers. The supplier and date of arrival will be documented.
NUMBER OF ANIMALS:
Twenty (20) test animals, ten (10) naive control, four (4) animals per pilot study will be used. When possible, equal numbers of males and females will be included in both test and control groups.
IDENTIFICATION OF ANIMALS:
Cage cards incorporating an animal group code - arrival date - color code marking system, will be used to identify each guinea pig.
SELECTION:
The animals will be randomly caged according to Standard Operating Procedures.
HOUSING AND ANIMAL CARE:
Prior to use, all animals will be quarantined for at least four days. Animals will be housed individually in wire mesh suspension cages. PURINA GUINEA PIG CHOW (or other comparable diet) will be fed ad libitum during both quarantine and test period. Tap water will be provided ad libitum. No analysis is required since there are no known contaminants expected that would interfere with the study. The animals will be kept on a 12-hour light/12-hour dark cycle. - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 hours per day, once per week for 3 weeks
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 hours on one day
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Ten males and ten females were used in the induction primary challenge. Five males and five females were used in the primary challenge phase as naive controls.
- Details on study design:
- Irritation Screen:
Exposure of the guinea pigs can be divided into three phases: Irritation, Inductino, and Challenge.
The irritation Phase has the purpose of determining the proper level of test article to be used in the induction and (or) Challenge Phase. If the test article is known not to be an irritant, the irritation evaluation need not be run. If the irritation potentials are unknown, from one to four levels of test article per animal, formulated in the solvent appropriate for a given study phase, may be evaluated. Generally, the concentration selected by the study director should be no more than slightly irritating as defined by the study director.
If all tested levels cause irritation, additional levels may need to be tested. The position of the different concentrations of test materials on the animals should be varied to adjust for possible site-to-site variations in response. The irritation evaluations can be done before or during the study phases as appropriate.
In preparation, remove the hair from the animals' backs using a small animal clipper. Do this the day before applying the test article. Apply closed patches to the animals in the following manner: Apply an appropriate volume of each test article into the selected patch system. Place the animal into the restrainer and apply the patch(es) to the clipped surface as guickly as possible. Occlude the patch with a rubber dental dam pulled taut and fastened to the bottom of the restrainer with clips. Adjust the restrainer to minimize movement of the animal during exposure. Approximately six (6) hours later remove the dental dam and patch(es), take the animal from the restrainer and place it in its cage. Excess material may be removed by an appropriate solvent. The day following the irritation exposure, depilate and score all animals as described under "Observations".
Primary Irritation Concentration Levels:
Pilot Number 1 (2 males and 2 females): 5, 2.5, 1 and 0.5% w/v in acetone
Pilot Number 2 (2 males and 2 females): 100, 50, 25, and 10% w/v in acetone
Induction Phase:
The purpose of this phase is to dermally expose the animals so that, if the material is a sensitizer, the animal can develop an immunological response. Although it is not necessary, the level of test article used may be irritating, but should not cause an excessive response. A level several times greater than the anticipated human exposure should be used if possible.
Clip the left shoulder of each animal with a small animal clipper the day before exposure. Apply closed patches to the clipped area of the guinea pigs. Expose and restrain the animals as previously described under Irritation screen. Repeat the procedure at the same site once a week for the next two (2) weeks for atotal of three approximate 6-hour exposures (the interval between induction exposures may vary from 5 to 9 days). Should excessive irritation (as defined by the study director) appear at the induction sites during the induction pahse, patches may still be placed within the same left shoulder area, taking care to avoid this irritation. After the last induction exposure, leave the animals untreated for approximately two (2) weeks (12-16 days) before primary challenge.
Induction Phase concentration level: 100%
Challenge Phase:
The test animals which have had three previous exposures to the test material at appropriate intervals are again exposed in the Challenge Phase. In addition, ten animals (naive control) which have never been exposed to the test article are treated with the same concentration.
Challenge the animals previously exposed during the induction period as well as the previously untreated control animals approximately two (2) weeks after the last induction exposure. Use the same patching procedure as for the "induction Phase," but apply the patches to a skin site that has not been exposed previously. The site for challenge may be varied as necessary to achieve the objectives of the experiment (e.G., using multiple samples at challenge will require using several sites).
Observations:
The day following the primary challenge exposure, depilate all animals with a commercial depilatory. Place the depilatory on the test sites and surrounding areas, and leave it on for no more than fifteen (15) minutes. Thoroughly was hoff the depilatory with warm, running water, dry the animals with a towel and return them to their cages.
A minimum of two (2) hours after depilation, grade the test sites on a scale of 0 to 3 (0 = no reaction, +/- = slightly patchy erythema, 1 = slight but confluent, or moderate patchy erythema, 2 = moderate erythema, 3 = severe erythema with or without edema) (report as 24 hour scores). Repeat the grading the following day. For reporting purposes the first and second gradings will be sesignated as 24 and 48 hour reading respectively.
Grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen on control animals. If grades of 1 or greater are noted on control animals, then the reactions of test animals that exceed the most severe control reaction are presumed to be due to sensitization. Occasionally, test animals may have a higher incidence of skin reactions that are comparable in intensity (e.g., +/-) to controls, without a single animal being more reactive. In these instances, a rechallenge may be necessary to clearly define the mechanism. - Challenge controls:
- Primary Challenge:
Five male and five female naive animals were exposed to the undiluted test material. - Positive control substance(s):
- no
- Positive control results:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No Data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No Data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Naive Control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No Data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Naive Control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No Data.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: Naive Control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Naive Control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The potential of the test material to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler*.
Following primary challenge, there were no erythema responses produced in any of the test or control animals. These data indicate that the test material did not induce a sensitising response. - Executive summary:
The potential of the test material to produce delayed contact hypersensitivity in male and female guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler*. Study methodology followed was equivalent ot similar to OECD 406 in accordance with the Principles of Good Laboratory practice (GLP).
Following primary challenge, there were no erythema responses produced in any of the test or control animals. These data indicate that the test material was not a sensitiser
Reference
The test material at 100% undiluted was determined to be the appropriate concentration for the Primary Challenge based on the results of the Primary Irritation phase studies (Pilot no.1 and 2).
Skin Grades Following Primary Challenge in Guinea Pigs:
Test Material (100% undiluted) in Induced AnimalsaWR
|
|
Numerical Score |
|
Animal Number |
Sex |
24-Hour |
48-Hour |
T-1 BK622 |
M |
0 |
0 |
T-2 BK622 |
M |
0 |
0 |
T-3 BK622 |
M |
0 |
0 |
T-4 BK622 |
M |
0 |
0 |
T-5 BK622 |
M |
0 |
0 |
T-6 BK622 |
M |
0 |
0 |
T-7 BK622 |
M |
0 |
0 |
T-8 BK622 |
M |
0 |
0 |
T-9 BK622 |
M |
0 |
0 |
T-10 BK622 |
M |
0 |
0 |
T-11 BK622 |
F |
0 |
0 |
T-12 BK622 |
F |
0 |
0 |
T-13 BK622 |
F |
0 |
0 |
T-14 BK622 |
F |
0 |
0 |
T-15 BK622 |
F |
0 |
0 |
T-16 BK622 |
F |
0 |
0 |
T-17 BK622 |
F |
0 |
0 |
T-18 BK622 |
F |
0 |
0 |
T-19 BK622 |
F |
0 |
0 |
T-20 BK622 |
F |
0 |
0 |
Mean |
0.0 |
0.0 |
apatch site location # 2 was used in accordance with that specified in Appendix A of the protocol.
W = At second and third inductions, and primary challenge the respective sites were wiped with a dry paper towel to remove excess sample.
R = Red sample stain interfered with scoring.
Test Material (Undiluted) in Naive AnimalsaPR
|
|
|
Numerical Score |
|
Animal Number |
Sex |
Site Orderb |
24-Hour |
48-Hour |
C-21 RD/BK622 |
M |
AB |
0 |
0 |
C-22 RD/BK622 |
M |
BA |
0 |
0 |
C-23 RD/BK622 |
M |
AB |
0 |
0 |
C-24 RD/BK622 |
M |
BA |
0 |
0 |
C-25 RD/BK622 |
M |
AB |
0 |
0 |
C-26 RD/BK622 |
F |
BA |
0 |
0 |
C-27 RD/BK622 |
F |
AB |
0 |
0 |
C-28 RD/BK622 |
F |
BA |
0 |
0 |
C-29 RD/BK622 |
F |
AB |
0 |
0 |
C-30 RD/BK622 |
F |
BA |
0 |
0 |
Mean |
0.0 |
0.0 |
aAnimals were common to this study and one other Morton-Thiokol, Inc., study (HTB Project No. 89-3809-21).
bA = Automate Blue 8 7121-536 (HTB project No. 89-3808-21);
B = Automate Red B 7111-2818 (HTB Project No. 89-3809-21). The letter which appears first was placed at site # 2 and the letter which appears second was placed at site # 5 as shown in Appendix A of the protocol.
P = All sites were wiped with a dry paper towel following removal.
R = Red samples stain interfered with scoring.
Individual Body Weight Data in Guinea Pigs
|
|
Body Weight (grams) |
|
Animal Number |
Sex |
Initial |
Terminal |
T-1 BK622 |
M |
519 |
757 |
T-2 BK622 |
M |
491 |
838 |
T-3 BK622 |
M |
450 |
688 |
T-4 BK622 |
M |
485 |
755 |
T-5 BK622 |
M |
454 |
668 |
T-6 BK 622 |
M |
493 |
788 |
T-7 BK 622 |
M |
467 |
785 |
T-8 BK 622 |
M |
459 |
706 |
T-9 BK 622 |
M |
491 |
760 |
T-10 BK 622 |
M |
503 |
776 |
T-11 BK 622 |
F |
431 |
610 |
T-12 BK 622 |
F |
404 |
555 |
T-13 BK 622 |
F |
410 |
586 |
T-14 BK 622 |
F |
428 |
620 |
T-15 BK 622 |
F |
366 |
560 |
T-16 BK 622 |
F |
420 |
640 |
T-17 BK 622 |
F |
440 |
648 |
T-18 BK 622 |
F |
426 |
601 |
T-19 BK 622 |
F |
441 |
568 |
T-20 BK 622 |
F |
442 |
665 |
C-21 RD/BK622 |
M |
491 |
768 |
C-22 RD/BK622 |
M |
471 |
720 |
C-23 RD/BK622 |
M |
476 |
708 |
C-24 RD/BK622 |
M |
490 |
792 |
C-25 RD/BK622 |
M |
464 |
610 |
C-26 RD/BK622 |
F |
467 |
621 |
C-27 RD/BK622 |
F |
450 |
670 |
C-28 RD/BK622 |
F |
398 |
600 |
C-29 RD/BK622 |
F |
425 |
607 |
C-30 RD/BK622 |
F |
455 |
619 |
P-41 RD622 |
M |
482* |
ND |
P-42 RD622 |
M |
435* |
ND |
P-43 RD622 |
F |
416* |
ND |
P-44 RD622 |
F |
457* |
ND |
P-45 RD622 |
M |
436* |
ND |
P-46 RD622 |
M |
452* |
ND |
P-47 RD622 |
F |
458* |
ND |
P-48 RD622 |
F |
456* |
ND |
*=Weights taken prior to dosing.
ND=No data.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The potential of undiluted Automate Red B Nonvolatile to produce delayed contact hypersensitivity in male and female guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler*. Study methodology followed was equivalent ot similar to OECD 406 in accordance with the Principles of Good Laboratory practice (GLP).
Following primary challenge, there were no erythema responses produced in any of the test or control animals. These data indicate that sensitization to Automate Red B had not been induced.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification required
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