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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
- 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
Skin irritation:
In an OECD guideline and GLP compliant primary skin irritation test in
rabbits with the test item neither erythema nor edema were
observed at reading times 24, 48 and 72 h in any animal. Therefore,
Pigment Yellow 191 can be regarded as not skin irritating.
Eye irritation:
In an OECD guideline and GLP compliant primary eye irritation test in
rabbits with the test item only slight ocular reactions were observed
for conjunctival redness in 2 animals (mean 0.33 of 24, 48, 72 h
readings), which were fully reversible within 48 h. Therefore, Pigment
Yellow 191 can be regarded as not eye irritating.
Respiratory tract:
Based on available data the substance is considered likely to behave
like an inert dust. Consequently the substance is considered not to
exert any local irritative effects. Therefore, it is concluded, that
testing is not necessary to reach the scientific conclusion that
classification is not warranted.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- well performed GLP and OECD 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)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG breeding colony
- Age at study initiation: 3 months to 5 months
- Weight at study initiation: 2.1 kg to 2.3 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) and appr. 15 g hay daily, ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethyleneglycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.9 mL
- Lot/batch no. (if required): Ch-B 2322 , Riedel de Haen AG - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
About 24 h before the start of the study the hair in the dorsal region of the body of the animals was removed with an electric clipper over an area of about 25 cm2.
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG), fixed to the prepared skin area and covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
as in EU Method B.4, assessed approximately 30 - 60 min, 24, 48, and 72 h after the removal of the patches - Irritation parameter:
- erythema score
- Basis:
- animal: # 76, 77, 78 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: initial signs of slight irritation (erythema) were fully reversible within 24 hours
- Irritation parameter:
- edema score
- Basis:
- animal: # 76, 77, 78 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritant / corrosive response data:
- Scores (oedema or erythema) were 0 at 24, 48 and 72 h readings after removal of dressing in all animals.
- Other effects:
- Yellow staining produced by the yellow colour of the test item was present at all reading time points.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- no effects (erythema and oedema) were observed at 24, 48 and 72 h readings. Therfore, the test item is regarded as not irritating to the skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by semi-occlusive application of 0.5 g of the test item mixed with 0.9 mL of Polyethyleneglycol 400 to the intact dorsal region of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 24 hours after treatment for all animals. Staining of the treated skin was noted in all animals throughout the whole study. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.
Therefore, the test item has not to be classified as irritating to the skin 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
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal: # 76, 77, 78 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: initial signs of slight irritation (erythema) were fully reversible within 24 hours
- Irritation parameter:
- edema score
- Basis:
- animal: # 76, 77, 78 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Interpretation of results:
- not irritating
- Conclusions:
- no effects (erythema and oedema) were observed at 24, 48 and 72 h readings. Therfore, the test item is regarded as not irritating to the skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by semi-occlusive application of 0.5 g of the test item mixed with 0.9 mL of Polyethyleneglycol 400 to the intact dorsal region of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 24 hours after treatment for all animals. Staining of the treated skin was noted in all animals throughout the whole study. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.
Therefore, the test item has not to be classified as irritating to the skin according to Regulation (EC) no 1272/2008.
- 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- well performed GLP and OECD guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG breeding colony
- Age at study initiation: 3 months to 5 months
- Weight at study initiation: 2.3 kg to 2.6 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) and appr. 15 g hay daily, ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each treated animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single instillation, exposure period: 24 hours (washing 24 h after instillation)
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively
REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
The eyes were examined 1, 24, 48 and 72 hours after application of the test item
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light (24 and 72 hour readings) - Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since on effects occured
- Irritation parameter:
- iris score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1 hour after application inflammation grade 1 was observed in all animals, which was fully reversible after 24 h.
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1 hour after application grade 1 and 2 chemosis was observed in all animals, which was fully reversible within 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1 hour after application grade 2 conjunctival redness was observed in all animals, which was fully reversible for animal #2 within 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1, 3 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 1 hour after application grade 2 conjunctival redness was observed in all animals, which was fully reversible for animals #1 and #3 within 48 h
- Irritant / corrosive response data:
- 1 hour after application the treated eyes of all animals exhibited a slight injection of conjunctival blood vessels up to a diffuse, beefy red colour as well as slight swellings. the iris of all animals was reddened. Additionally yellow discharge was noted.
- Other effects:
- no other effects reported
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- All recorded ocular reactions were fully reversible within 48 h an all mean scores were well below the threshold values for classification. Therefore, the test item has not to be classified as irritation to the eyes according to Regulation (EC) No 1272/2008.
- Executive summary:
A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.
1 hour after application the treated eyes of all animals exhibited a slight injection of conjunctival blood vessels up to a diffuse, beefy red colour as well as slight swellings and the iris of all animals was reddened. Additionally yellow discharge was noted. But mean scores (mean of 24, 48, and 72 h) of all animals were well below the threshold values for classification. 48 hours after treatment all signs of irritation were fully reversible.
Therefore, the test item has not to be classified as irritation to the eyes according to Regulation (EC) No 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since on effects occured
- Irritation parameter:
- iris score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1 hour after application inflammation grade 1 was observed in all animals, which was fully reversible after 24 h.
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1 hour after application grade 1 and 2 chemosis was observed in all animals, which was fully reversible within 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1 hour after application grade 2 conjunctival redness was observed in all animals, which was fully reversible for animal #2 within 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1, 3 each
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 1 hour after application grade 2 conjunctival redness was observed in all animals, which was fully reversible for animals #1 and #3 within 48 h
- Irritant / corrosive response data:
- 1 hour after application the treated eyes of all animals exhibited a slight injection of conjunctival blood vessels up to a diffuse, beefy red colour as well as slight swellings. the iris of all animals was reddened. Additionally yellow discharge was noted.
- Interpretation of results:
- not irritating
- Conclusions:
- All recorded ocular reactions were fully reversible within 48 h an all mean scores were well below the threshold values for classification. Therefore, the test item has not to be classified as irritation to the eyes according to Regulation (EC) No 1272/2008.
- Executive summary:
A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.
1 hour after application the treated eyes of all animals exhibited a slight injection of conjunctival blood vessels up to a diffuse, beefy red colour as well as slight swellings and the iris of all animals was reddened. Additionally yellow discharge was noted. But mean scores (mean of 24, 48, and 72 h) of all animals were well below the threshold values for classification. 48 hours after treatment all signs of irritation were fully reversible.
Therefore, the test item has not to be classified as irritation to the eyes according to Regulation (EC) No 1272/2008.
- 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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
only one study available
Justification for selection of eye irritation endpoint:
only one study available
Justification for classification or non-classification
Pigment Yellow 191 has been tested in vivo for skin irritative properties in rabbits. In this OECD guideline and GLP compliant study, the substance did not cause any skin reactions at reading times 24, 48 and 72 h in any animal. Therefore, Pigment Yellow 191 does not have to be classified as skin irritating according to Directive 67/548/EEC and Regulation (EU) No 1272/2008.
Pigment Yellow 191 has been tested in vivo for eye irritative properties in rabbits according to OECD guideline and GLP. In this study slight signs of irritation were observed for conjunctival redness in 2 animals. The mean of scores read 1, 2 and 3 days after treatment were well below the classification criteria laid down in the Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, Pigment Yellow 191 does not have to be classified as eye irritating.
It can reasonably be deduced that Pigment Yellow 191 does not cause respiratory tract irritation and thus does not have to be classified according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008, because Pigment Yellow 191 did cause only very slight, fully reversible irritative effects in the eyes and no skin reactions 1, 2 and 3 days after treatment and does not have to be classified as either skin or eye irritating. Moreover, Pigment Yellow 191, in the unlikely event of being inhaled as a dust, is considered not to cause more severe effects than an inert dust.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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