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EC number: 228-819-0 | CAS number: 6359-98-4
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11
- Version / remarks:
- February 1965
- GLP compliance:
- no
- Remarks:
- pre GLP
Test material
- Reference substance name:
- Acid Yellow 017
- IUPAC Name:
- Acid Yellow 017
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12-16 weeks.
- Weight at study initiation: average body weights of 2.80 males and 2.60 kg females.
- Housing: rabbits were caged singly.
- Diet: commercial irradiated diet (Styles-Oxoid), ad libitum.
- Water: sterile filtered water, ad libitum.
- Acclimation period: one week prior to the start of the trial.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Relative humidity: 50-70 %
- Photoperiod: animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact shaved skin and abraded skin
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 6 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours prior to the dermal application, the backs of the rabbits were shaved. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded uith the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneurn but not to damage the dermis. The left hand site remained intact.
- % coverage: area consisting of at least 10 % of the total body surface.
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6 wide "Coban" self adhesive bandage in order to retain the test substance in close contace with the skin.
SCORING SYSTEM
The assessment of the macroscopic skin reaction was made according to the following grading system:
Primary Irritation Score
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 . 6.5 Severely irritating
6.6 - 8.0 Extremely irritating
Erythema and Eschar Formation - Description
No erythema 0
Slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet red) to slight eschar formation 4
Oedema Formation - Description
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm.) 3.
Severe-oedema (raised more than 1 mm. and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6, both intact and abraded skin
- Time point:
- other: 24/72 hrs
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6, both intact and abraded skin
- Time point:
- other: 24/72 hrs
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- The primary irritation score was 1.8.
Slight to well defined erythema and wery slight to moderate oedema were seen on all rabbits 24 hours after application of the compound. By 72 hours there was only one abraded site still showing slight erythema and very slight oedema. This was normal by 6 days.
There was uery little difference in the reactions seen between abraded and intact sites.
Any other information on results incl. tables
Skin irritation reactions
N./sex | Intact skin | Abraded skin | ||||
24 hrs | 72 hrs | 6 days | 24 hrs | 72 hrs | 6 days | |
Erythema |
||||||
11M | 1 | 0 | 0 | 2 | 0 | 0 |
13M | 1 | 0 | 0 | 2 | 0 | 0 |
15M | 1 | 0 | 0 | 1 | 0 | 0 |
12F | 1 | 0 | 0 | 2 | 1 | 0 |
14F | 1 | 0 | 0 | 2 | 0 | 0 |
16F | 2 | 0 | 0 | 2 | 0 | 0 |
Mean | 1.17 | 0.00 | 0.00 | 1.83 | 0.17 | 0.00 |
Oedema |
||||||
11M | 2 | 0 | 0 | 2 | 0 | 0 |
13M | 2 | 0 | 0 | 2 | 0 | 0 |
15M | 1 | 0 | 0 | 2 | 0 | 0 |
12F | 2 | 0 | 0 | 3 | 1 | 0 |
14F | 3 | 0 | 0 | 2 | 0 | 0 |
16F | 1 | 0 | 0 | 1 | 0 | 0 |
Mean | 1.83 | 0.00 | 0.00 | 2.00 | 0.17 | 0.00 |
Applicant's summary and conclusion
- Conclusions:
- Mild irritating
- Executive summary:
Method
The skin irritation was determined in an irritation test on rabbits according the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)., similar to OECD guideline 404.
Result
The primary irritation score was 1.8.
Mild irritating
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