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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5-19-1993 to 5-22-1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: EPA/OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol
- EC Number:
- 915-586-1
- Molecular formula:
- Variable; substance is a UVCB.
- IUPAC Name:
- Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol
- Test material form:
- other: Semi-solid
- Details on test material:
- The test material was a red colored semi-solid, identified as Automate Yellow 8 Petroleum. The test material was administered undiluted. Records of the test article stability, purity, source, and other data required by Federal Regulations will be maintained by the Sponsor.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six young adult, male New Zealand Albino rabbits were used for this study. The rabbits were obtained from Oak Hill, Holland, Michigan, and weighed between 2.30 and 2.71 kg at study initiation. The rabbits were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity and light-controlled room in our AAALAC accredited facility (rm. 14). The animals were maintained according to the recommendations contained in the DHHS Publication No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for five days prior to the initiation of the study. Purina Rabbit Chow (ca. 350 gm) was placed in the feeders each morning during the study. Tap water from an automatic watering system was available ad libitum from arrival until termination. Six animals were selected randomly from the acclimated colony and assigned to the test group. The animals used for this study were considered to be in good health at study initiation.
Justification for Selection of Test System: The New Zealand Albino rabbit has been used extensively as an animal model for skin irritation testing.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of undiluted test material.
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- Rabbits were weighed at the initiation and termination of the study. Dermal irritation readings were performed approximately 30 minutes after patches were removed (4.5 hours), as well as 24, 48 and 72 hours after treatment.
- Number of animals:
- 6 animals.
- Details on study design:
- Twenty four hours prior to study initiation, electric clippers were used to remove the hair from an 8 x 8 cm area located on the left flank of each animal. 0.5 grams of the test material was flattened into a wafer and applied to the intact site of each rabbit. The test material was then covered with a 4 x 4 gauze pad and the entire trunk wrapped with 4 mil plastic wrap. The ends of the plastic wrap were then sealed with surgical tape. The covering material was removed after a four hour contact period, and excess test material was wiped from the site. The study was terminated at the end of 4 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: unabraded sites
- Irritation parameter:
- edema score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: unabraded sites
Any other information on results incl. tables
Grading and scoring of irritation were performed in accordance with the Draize scoring system (Appendix 1). Individual and group mean body weights as well as individual and mean primary skin irritation scores for the test material are presented in Appendix 2. There was no irritation observed in any of the six animals thoughout the study. The Primary Irritation Index, based upon 4.5, 24, 48 and 72 hour scores, was 0/8.00.
APPENDIX 2: INDIVIDUAL AND MEAN PRIMARY SKIN IRRITATION SCORES (Unabraded sites)
Animal # |
Initial Weight (kg) |
Final Weight (Kg) |
4.5 Hours |
24 Hours |
48 Hours |
72 Hours |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|||
435 |
2.30 |
2.35 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
441 |
2.33 |
2.40 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
448 |
2.54 |
2.59 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
449 |
2.31 |
2.44 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
452 |
2.55 |
2.57 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
454 |
2.71 |
2.78 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean +SD |
2.46 0.17 |
2.52 0.16 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Daily Mean Primary Irritation Score (=er+ed) |
0 |
0 |
0 |
0 |
||||||
Primary Irritation Index (4.5, 24, 48 and 72 hrs/4) |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the results of this study the test material, Automate Yellow 8 Petroleum, produced a Primary Irritation Index of 0/8.00 and would be considered non-irritating to the skin of the rabbit. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
- Executive summary:
Automate Yellow 8 Petroleum (0.5 g) was applied to an unabraded site on the shaved left flank of each of six male albino rabbits for a four hour contact period. The application sites were graded for skin irritation at 4.5, 24, 48 and 72 hours after compound administration. There was no irritation observed in any of the six animals thoughout the study. The Primary Irritation Index, based upon 4.5,24,48 and 72 hour scores, was 0/8.00. Based upon the results of this study the test material, Automate Yellow 8 Petroleum, produced a Primary Irritation Index of 0/8.00 and would be considered non-irritating to the skin of rabbits. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
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