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EC number: 276-701-2 | CAS number: 72496-88-9
- 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
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:
- From August 30 to September 30, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted testing guidelines.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was existing
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:CIBA-GEIGY Limited Animal Production
- Age at study initiation: no data
- Weight at study initiation: Males 367.6 g, Female to 376.3 g
- Housing:The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 845
- Water: fresh water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 3 °C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Injection: physiological saline, epidermal application: vaseline
- Concentration / amount:
- INDUCTION
FIRST
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % of the test item in physiological saline (w/v)
- 5 % of the test item in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
SECOND
Test group:
- 50 % of the test item (0.4 g per patch) in vaseline
Control group:
- vaseline only
CHALLENGE
Test and control group:
- 50 % of the test item (0.2 g per patch) in vaseline
Control group:
- vaseline only - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Injection: physiological saline, epidermal application: vaseline
- Concentration / amount:
- INDUCTION
FIRST
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % of the test item in physiological saline (w/v)
- 5 % of the test item in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
SECOND
Test group:
- 50 % of the test item (0.4 g per patch) in vaseline
Control group:
- vaseline only
CHALLENGE
Test and control group:
- 50 % of the test item (0.2 g per patch) in vaseline
Control group:
- vaseline only - No. of animals per dose:
- The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group.
- Details on study design:
- PRETEST:
Intradermal Induction
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest.
The following concentration of test article has been used for intradermal injection:
5 % in physiological saline (w/v).
Since 5 % of the test item in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal Applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of the test item have been examined on separate animals for the determination of the maximum subirritant concentration:
30 and 50 % in vaseline.
50 % in vaseline was the highest applicable concentration of the test article.
The tested concentrations did not induce erythema reactions.
MAIN STUDY
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.
A. INDUCTION EXPOSURE
FIRST INDUCTION
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
- No. of exposures: Three pairs of intradermal injections
- Exposure period: first week
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: shaved neck
- Concentrations:
Test group:
adjuvant/saline mixture 1:1 (v/v)
5 % of the test item in physiological saline (w/v)
5 % of the test item in the adjuvant/saline mixture (w/v)
Control group:
adjuvant/saline mixture 1:1 (v/v)
adjuvant/saline mixture 1:1 (v/v)
physiological saline
SECOND INDUCTION:
The application site of all animals was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application.
In the test group the test item was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
- No. of exposures: one application
- Exposure period: second week
- Test groups:10 males and 10 females
- Control group:5 males and 5 females
- Site:shaved neck
- Concentrations:
Test group:
0.4 g of Acid Yellow 151 within vaseline
Control group:
vaseline only
B. CHALLENGE EXPOSURE
The test and control group animals were tested on one flank with the test item in vaseline (w/w) and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
- No. of exposures:
- Day(s) of challenge: Fifth week
- Exposure period:24 hours
- Test groups:10 males and 10 females
- Control group:5 males and 5 females
- Site: flank
Test
0.2 g per patch of the test item in vaseline
control group
vaseline only
- Evaluation (hr after challenge):
Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale
OTHER:
After the intradermal and the epidermal induction application skin irritation is normally induced by the adjuvant, the high test article concentration, or the sodium lauryl sulfate pretreatment. Because most of the reactions are treatment related and not test article related ,the reactions are
generally not described in the results section. - Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 mg/L
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 mg/L. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 mg/L
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 mg/L. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Group:
- negative control
- Remarks on result:
- other: For further details see tables below
- Group:
- positive control
- Remarks on result:
- other: For further details see tables below
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance in the experimental condition shows an extreme grade of allergenic potential in albino guinea pig.
- Executive summary:
The test item has been tested according to the OECD 406 (Guinea pig maximisation test).
Under the experimental conditions employed, all the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
Reference
Under the experimental conditions employed, 100 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. The test item is, therefore, classified as an extreme sensitizer in albino guinea pigs according to the grading of Magnusson and Kligman.
Score 24 hours after removal of the dressing
Male animals | 156 | 157 | 158 | 159 | 160 | 161 | 162 | 163 | 164 | 165 |
Erythema score: | 2 | 1 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
Edema score: | 2 | 1 | 2 | 1 | 2 | 1 | 2 | 2 | 1 | 2 |
Female animals | 171 | 172 | 173 | 174 | 175 | 176 | 177 | 178 | 179 | 180 |
Erythema score: | 2 | 2 | 2 | 2 | 22 | 2 | 1 | 1 | 1 | 2 |
Edema score: | 1 | 2 | 1 | 1 | 2 | 2 | 1 | 1 | 1 | 2 |
Score 48 hours after removal of the dressing
Male animals | 156 | 157 | 158 | 159 | 160 | 161 | 162 | 163 | 164 | 165 |
Erythema score: | 2 | 1 | 2 | 2 | 2S | 2 | 2 | 2 | 2 | 2 |
Edema score: | 2 | 2 | 2 | 1 | 3 | 2 | 2 | 2 | 2 | 2 |
Female animals | 171 | 172 | 173 | 174 | 175 | 176 | 177 | 178 | 179 | 180 |
Erythema score: | 2 | 2 | 2S | 2 | 2S | 2S | 1 | 1 | 1 | 2S |
Edema score: | 2 | 2 | 3 | 2 | 3 | 3 | 2 | 2 | 2 | 3 |
S= scaling
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The supporting studies are conducted with degree of purity of test substance of 64 %. The results are: non or weak sensitizer. The main study was conducted with degree of purity of the test substance of 74.4 %. The result is that all tested animals were sensitised by Acid Yellow 151 under the experimental conditions employed.
Justification for selection of skin sensitisation endpoint:
Study conducted in 1993 , GLP compliant and conducted according to internationally accepted testing guidelines.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the Regulation EC n. 1272/2008 skin sensitizer means a substance that will lead to an allergenic response following skin contact. Acid Yellow 151 give a positive reaction to all animals within the main test, therefore the substance Acid Yellow 151 is classified as H317: Skin sensitizer category 1B.
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