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EC number: 915-586-1 | CAS number: -
- 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
In vivo Skin sensitising potential assay performed in accordance with a Buehler method.
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:
- 6-4-1993 to 7-12-1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: EPA guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- study performed prrior to the requirement to perform the LLNA as the first choice method for skin sensitising potential.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Young adult male Hartley albino guinea pigs were used for this study and weighed between 230 and 298 grams at study initiation. The guinea pigs were obtained from Oak Hill, Holland, Michigan.
The guinea pigs used for this study were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity, and light-controlled room (room 15A). The animals were maintained according to the recommendations contained in DHHS Publications No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for 5 days prior to initiation of the study. Purina Guinea Pig chow and water were available ad libitum. The animals were selected randomly from the acclimated colony and assigned to the test groups. All animals used for this study appeared to be in good health at study initiation.
Justification for Selection of Test System: The albino guinea pig has been used extensively as an animal model for dermal sensitization studies. - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 g of undiluted test material.
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 g of undiluted test material.
- No. of animals per dose:
- The test material was administered topically to ten guinea pigs.
- Details on study design:
- The test material was administered undiluted for all induction and challenge doses. Data from a primary skin irritation study indicated that the test article administered undiluted caused no skin irritation. The test material was administered topically to ten guinea pigs according to a modification of the method of Buehler (Buehler, E.V., Delayed contact hypersensitivity in the guinea pig. Arch. Dermatol. 91 :171-175, 1965).
An area of approximately 2 x 2 cm was shaved (electric clippers) on the left trunk of each animal on the first day of dosing. 0.5 grams of the test material was flattened into a wafer, and placed into a Hilltop Chamber with the pad removed. The test site was lubricated with 0.2 ml of mineral oil since the test material acted as a depilatory upon removal. The chamber was then applied to the test site, overwrapped (around the entire trunk) with Micropore, and the animal returned to its cage. The animal was unwrapped and the chamber removed after a 24 hour (initial dose) or six hour (nine succeeding induction doses) contact period. Animals were treated at least three times weekly (with at least one day intervening between treatments) for a total of ten treatments. Animals were reshaven when necessary prior to the application of a chamber. Two weeks after the final induction dose, each animal received a topical challenge dose (24 hr. contact) on a 2 x 2 cm shaved area located on the right trunk. Animals were scored for irritation 24 and 48 hours after each application. - Challenge controls:
- Using the same regimen, six guinea pigs received 0.5 ml of a 0.1 % solution of 1-chloro 2,4 dinitrobenzene in 80% aqueous ethanol, to serve as a positive control. Two negative control animals were also challenged using the test material (24 hour contact period). The remaining two negative controls remained untreated.
- Positive control substance(s):
- yes
- Remarks:
- 0.5 ml of a 0.1 % solution of 1-chloro 2,4 dinitrobenzene in 80% aqueous ethanol
- Positive control results:
- The initial dose of 1-chloro 2,4 dinitrobenzene produced no positive irritation scores in any of the guinea pigs. The ten dose average irritation score was 0.39 for 1-chloro 2,4 dinitrobenzene. The average score for the challenge dose of 1- chloro 2,4 dinitrobenzene was 1.08. The challenge dose of 1-chloro 2,4 dinitrobenzene resulted in a positive reaction in 6/6 guinea pigs characterized by a grade 1 for erythema and/or edema.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- 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: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data..
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- 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: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data..
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Clinical observations:
- No data.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 2.0. Clinical observations: No data..
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Clinical observations:
- No data.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 2.0. Clinical observations: No data..
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % solution of 1-chloro 2,4 dinitrobenzene in 80% aqueous ethanol
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- No data.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % solution of 1-chloro 2,4 dinitrobenzene in 80% aqueous ethanol. No with. + reactions: 6.0. Total no. in groups: 6.0. Clinical observations: No data..
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % solution of 1-chloro 2,4 dinitrobenzene in 80% aqueous ethanol
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- No data.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 % solution of 1-chloro 2,4 dinitrobenzene in 80% aqueous ethanol. No with. + reactions: 6.0. Total no. in groups: 6.0. Clinical observations: No data..
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on comparisons of the initial test dose response to the challenge test dose and to the reactions elicited by the positive and negative controls, Automate Yellow 8 Petroleum would not be considered a dermal sensitizing agent.
- Executive summary:
Automate Yellow 8 Petroleum (0.5 g) was placed directly into a Hilltop Chamber and applied to the shaved left trunk of ten albino guinea pigs. The chamber was then overwrapped (around the entire trunk) with Micropore tape and further secured with a wrap of surgical tape The animals were unwrapped after a 24 hour exposure period (initial dose). Nine succeeding induction doses were unwrapped after a 6 hour exposure period. This procedure was repeated three times weekly (with at least one day intervening between treatments) for a total of ten applications. Two weeks after the final application the animals received a topical challenge dose (24 hour contact) at a naive site located on the right trunk. Animals were scored for irritation 24 and 48 hours after each application.
Using the same regimen, six guinea pigs received 0.5 ml of a 0.1 % solution of 1-chloro 2,4 dinitrobenzene in (80% aqueous ethanol) to serve as a positive control. Four guinea pigs were observed as a negative control. Two negative control animals were also challenged using the test material.
The initial dose of Automate Yellow 8 Petroleum or 1-chloro 2,4 dinitrobenzene produced no positive irritation scores in any of the guinea pigs. The ten dose average irritation score was 0 for Automate Yellow 8 Petroleum. The ten dose average irritation score for 1-chloro 2,4 dinitrobenzene was 0.39.
Average scores for the challenge dose were 0 for Automate Yellow 8 Petroleum and 0 for the challenged negative controls. The average score for the challenge dose of 1-chloro 2,4 dinitrobenzene was 1.08.
The challenge dose of Automate Yellow 8 Petroleum, and two negative control animals challenged with Automate Yellow 8 Petroleum, did not elicit a positive response. The challenge dose of 1-chloro 2,4 dinitrobenzene resulted in a positive response in 6/6 guinea pigs,
characterized by a grade 1 for erythema and/or edema.
Based on comparisons of the initial test dose response to the challenge test dose and to the reactions elicited by the positive and negative controls, Automate Yellow 8 Petroleum would not be considered a dermal sensitizing agent.
Reference
Appendix 1: INDIVIDUAL AND GROUP MEAN BODY WEIGHTS
Test Group (Automate Yellow 8 Petroleum)
Animal # |
Initial Weight (g) |
7-Day Weight (g) |
14-Day Weight (g) |
21-Day Weight (g) |
Final Weight (g) |
342 |
268 |
317 |
397 |
472 |
635 |
343 |
298 |
387 |
484 |
568 |
742 |
345 |
291 |
364 |
428 |
531 |
679 |
357 |
230 |
286 |
336 |
394 |
540 |
358 |
250 |
312 |
376 |
450 |
626 |
365 |
286 |
315 |
383 |
450 |
598 |
370 |
283 |
330 |
405 |
468 |
605 |
375 |
272 |
310 |
388 |
481 |
624 |
383 |
257 |
305 |
370 |
439 |
573 |
386 |
277 |
320 |
392 |
458 |
595 |
Mean |
271 |
325 |
396 |
471 |
622 |
+/- S.D. |
21 |
30 |
39 |
48 |
56 |
Positive Control Group (1-Chloro-2,4-Dinitrobenzene)
Animal # |
Initial Weight (g) |
7-Day Weight (g) |
14-Day Weight (g) |
21-Day Weight (g) |
Final Weight (g) |
337 |
290 |
363 |
456 |
541 |
709 |
340 |
281 |
323 |
392 |
460 |
638 |
349 |
305 |
390 |
465 |
556 |
713 |
352 |
241 |
327 |
394 |
478 |
630 |
381 |
274 |
316 |
374 |
423 |
506 |
389 |
265 |
344 |
411 |
481 |
552 |
Mean |
276 |
344 |
415 |
490 |
625 |
+/- S.D. |
22 |
28 |
37 |
50 |
83 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Automate Yellow 8 Petroleum (0.5 g) was placed directly into a Hilltop Chamber and applied to the shaved left trunk of ten albino guinea pigs. The chamber was then overwrapped (around the entire trunk) with Micropore tape and further secured with a wrap of surgical tape The animals were unwrapped after a 24 hour exposure period (initial dose). Nine succeeding induction doses were unwrapped after a 6 hour exposure period. This procedure was repeated three times weekly (with at least one day intervening between treatments) for a total of ten applications. Two weeks after the final application the animals received a topical challenge dose (24 hour contact) at a naive site located on the right trunk. Animals were scored for irritation 24 and 48 hours after each application.
Using the same regimen, six guinea pigs received 0.5 ml of a 0.1 % solution of 1-chloro 2,4 dinitrobenzene in (80% aqueous ethanol) to serve as a positive control. Four guinea pigs were observed as a negative control. Two negative control animals were also challenged using the test material.
The initial dose of Automate Yellow 8 Petroleum or 1-chloro 2,4 dinitrobenzene produced no positive irritation scores in any of the guinea pigs. The ten dose average irritation score was 0 for Automate Yellow 8 Petroleum. The ten dose average irritation score for 1-chloro 2,4 dinitrobenzene was 0.39.
Average scores for the challenge dose were 0 for Automate Yellow 8 Petroleum and 0 for the challenged negative controls. The average score for the challenge dose of 1-chloro 2,4 dinitrobenzene was 1.08.
The challenge dose of Automate Yellow 8 Petroleum, and two negative control animals challenged with Automate Yellow 8 Petroleum, did not elicit a positive response. The challenge dose of 1-chloro 2,4 dinitrobenzene resulted in a positive response in 6/6 guinea pigs,
characterized by a grade 1 for erythema and/or edema.
Based on comparisons of the initial test dose response to the challenge test dose and to the reactions elicited by the positive and negative controls, Automate Yellow 8 Petroleum would not be considered a dermal sensitizing agent.
Justification for selection of skin sensitisation endpoint:
Reliable in vivo study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
This substance does not meet the criteria for classification as a sensitiser (skin) according to CLP
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