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EC number: 226-939-8 | CAS number: 5567-15-7
- 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
PY 83 was non irritant in rabbit skin and eyes in vivo.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 SEP 1996 to 10 SEP 1996.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory, Dr. K. Thomae, Biberach
- Weight at study initiation: 2.5-3.2 kg
- Housing: individually
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g pasted with 0.8 ml polyethylene glycol 400 (Riedel-de Haen) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of surgical plaster (Beiersdorf)
- Type of wrap: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD TG 404 - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 7 days after exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72 h after exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 7 days after exposure.
- Irritant / corrosive response data:
- From one hour up to 3 days after removal of the patches the treated skin of the animals showed very slight up to well defined erythema. 7 days after removal of the patches no signs of skin irritation were observed. Very slight edema was noted in 2/3 animals one hour after exposure. No edema were noted at any other time point.
- Other effects:
- The skin surface of the animals was dry, rough and light yellow discoloured.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test item is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
- Executive summary:
The test item material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. Very slight up to well defined erythema were observed in every animal, fully reversible within seven days. Very slight edema were observed in 2/3 animals only one hour after exposure, fully reversible within one day. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See justification doocument in Chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- other:
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Housing: individually
- Diet: NAFAG, Gossau SG, rabbit food, ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- No rinsing of eyes in 3 animals (group 1), rinsing after 30 seconds in other 3 animals (group 2)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No rinsing of eyes in 3 animals (group 1), rinsing after 30 seconds in other 3 animals (group 2) with 10 ml lukewarm water
SCORING SYSTEM: basically in accordance with OECD TG 405
TOOL USED TO ASSESS SCORE: slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: group 1 + group 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: group 1 + group 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 (group 1), #3, #4, #5 (group 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: no differentiation between redness, chemosis, discharge
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 (group 1), #3, #4, #5 (group 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no differentiation between redness, chemosis, discharge
- Irritant / corrosive response data:
- No eye responses were observed except conjunctivae score 6 (incl. chemosis, discharge) in animal #3 (group 1) 24 h after application, fully reversible by 48 h after application.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. This conclusion is legitimate as three animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and the observed eye responses were fully reversible 48 hours after application.
- Executive summary:
The test material was tested for eye irritancy according to the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 0.1 g test substance was applied to the conjunctival sac of one eye each of 6 animals (no washing in 3 animals, group 1, washing after 30 seconds in other 3 animals, group 2) and eye responses were watched for seven days. No eye responses were observed except conjunctival score 6 (incl. redness, chemosis, discharge) in animal #3 (group 1) 24 h after application, fully reversible by 48 h after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See Read across justification document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: group 1 + group 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: group 1 + group 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 (group 1), #3, #4, #5 (group 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: no differentiation between redness, chemosis, discharge
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 (group 1), #3, #4, #5 (group 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no differentiation between redness, chemosis, discharge
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See Read across justification document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: group 1 + group 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: group 1 + group 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 (group 1), #3, #4, #5 (group 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: no differentiation between redness, chemosis, discharge
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 (group 1), #3, #4, #5 (group 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no differentiation between redness, chemosis, discharge
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Rabbit #3 (group 1) | |||
Days after appl. | Cornea | Iris | Conjunctivae |
1 | 0 | 0 | 6 |
2 | 0 | 0 | 0 |
3 | 0 | 0 | 0 |
4 | 0 | 0 | 0 |
7 | 0 | 0 | 0 |
Conjunctivae = [Redness (max. score 3) + Chemosis (max. score 4) + Discharge (max. score 3)] x 2
The conjunctivae score for animal #3 one day after application is put together like (3 + 0 + 0) for redness score 3 or (0 + 3 + 0) for chemosis score 3 in the worst case. Discharge is not relevant for classification according to the criteria of Regulation (EC) No 1272/2008. Therefore, the maximum mean value for either conjunctival redness or chemosis over 24 h, 48 h and 72 h after application is 1, which falls below critical values for classification according to the criteria of Regulation (EC) No 1272/2008.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Studies investigating skin or eye irritation did not reveal any evidence of irritant potential of Pigment Yellow 83. Therefore, Pigment Yellow 83 is not
classified as skin, eye or respiratory tract irritant according to Regulation (EC) No 1272/2008.
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