Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 228-906-3 | CAS number: 6372-81-2
- 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
RA_PR 53.1_key_404_1988_Hoechst_88.1297: not irritating / not corrosive
QSAR PR 50.1 skin irritation OECD Toolbox: not classified
QSAR PR 53.1 skin irritation OECD Toolbox: not irritating
Eye
RA PR 53:1_key_405_1988_Hoechst_88.1376: not irritating
QSAR PR 50.1 eye irritation OECD Toolbox: not classified
QSAR PR 53.1 eye irritation OECD Toolbox: not irritating
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:
- according to OECD and GLP
- 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: New Zealand White , conventional breed
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.3 - 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) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (fully air-conditioned)
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: polyethylene glycol 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): 1.0 mL to moisten the test item
- Lot/batch no. (if required): polyethylene glycol 400, 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
approximately 24 h before treatment the test site was clipped free of hair (25 cm2).
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG), fixed with a semiocclusive 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 test item - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Animal 1: Erythema grade 1 observed at 30-60 min reading was fully reversible within 24 hours. Animal 2 & 3: Reversibility not relevant since no effects occured.
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- 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 after removal of dressing in all animals
- Other effects:
- light-red staining produced by the color of the test item was present in all animals at all reading time points.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank 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 slight, early-onset and transient erythema in one animal. This effect was reversible and no longer evident 24 hours after treatment. Light-red staining of the treated skin (caused by the color of the test item) was noted in all animals throughout the whole study. Mean scores of all animals for edema and erythema were 0. 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 for skin irritation/corrosion according to Regulation (EC) No 1272/2008.
Reference
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:
- According to OECD and GLP
- 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: New Zealand White, conventional breed
- Source: Hoechst AG, breeding colony
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.5 kg to 2.8 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) ad libitum, appr. 15 g hay daily
- 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 right untreated eye of each animal served as control respectively
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- One administration 24 hours
- 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
- Time after start of exposure: see above
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- 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 the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: grade 2 (2 anmials) and 1 (1 animal) was observed 1 hour after administration and was fully reversible within 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 each
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72 hours reading
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: grade 1 was observed 1 hour after administration and was fully reversible within 24 hours
- Irritant / corrosive response data:
- 1 hour after administration injected vessels up to diffuse crimson red colour and slight swelling of conjunctivae was observed in all animals. All signs of irritation were fully reversible after 48 h.
- Other effects:
- Red staining of eye discharge was observed at 1 hour after application.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a OECD guideline and GLP compliant primary eye irritation test in rabbits mean scores for cornea, iris and chemosis of conjunctiva were 0 for all animals. Mean scores for redness of conjunctiva were 0.3 for two and 0 for one animal. All signs of irritation were fully reversible after 48 h.
Therefore, the test item has not to be classified 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.
One and 24 hours after treatment the conjunctivae of the animals showed injected blood vessels up to a diffuse crimson red colour. Additionally, a slight swelling and slight from substance coloured eye discharge were observed in the animals one hour after treatment. Mean scores for cornea, iris and chemosis of conjunctiva were 0 for all animals. Mean scores for redness of conjunctiva were 0.3 for two and 0 for one animal. 48 hours after treatment all signs of irritation were reversible.
Therefore, the test item has not to be classified according to Regulation (EC) No 1272/2008.
Reference
Animal | Evaluation interval (after application) | Opacity of cornea | Redness of conjunctiva | Chemosis of conjunctiva | Iris | Red eye discharge | Fluoresceinestaining |
# 1 | 1 hour | 0 | 2 | 2 | 0 | x | |
# 2 | 0 | 2 | 2 | 0 | x | ||
# 3 | 0 | 1 | 1 | 0 | x | ||
# 1 | 24 hours | 0 | 1 | 0 | 0 | 0 | |
# 2 | 0 | 1 | 0 | 0 | 0 | ||
# 3 | 0 | 0 | 0 | 0 | 0 | ||
# 1 | 48 hours | 0 | 0 | 0 | 0 | ||
# 2 | 0 | 0 | 0 | 0 | |||
# 3 | 0 | 0 | 0 | 0 | |||
# 1 | 72 hours | 0 | 0 | 0 | 0 | 0 | |
# 2 | 0 | 0 | 0 | 0 | 0 | ||
# 3 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Discussion
No experimatal data are available for skin/eye irritation/corrosion of Pigment Red 50:1. Thus data were provided by application of read across using existing data from Pigment Red 53.1 to predict skin/eye irritation/corrosion of Pigment Red 50:1. The prediction for Pigment Red 50:1 reads as follows:
Skin: no irritating / not corrosive
Eye: not irritating
This read across derivation is strongly supported by QSAR analyses using the OECD Toolbox which predicts the following skin/eye irritation/corrosion:
Skin
Pigment Red 50:1: not classified
Pigment Red 53.1: not irritating
Eye
Pigment Red 50:1: not classified
Pigment Red 53:1: not irritating
The data sources used provide consistent data allowing the final conclusion that Pigment Red 50:1 is not irritating/corrosive to skin or eye.
Read Across Justification
The purpose of this assessment is to provide justification for read across in order to estimate acute oral toxicity of Pigment Red 50:1 (target substance) and to predict its possible irritant or corrosive properties after contact with skin or eyes based on existing date coming from Pigment Red 53:1 (source substance).
The pigments used in this approach are structurally similar and differ only by diverging substituents in the common core molecule. Target and source substance are solids which decompose at high temperatures (>= 306°C). Solubility in water or n-octanol is low or very low for the source substance (in water: 3.0 mg/L, in n-Octanol: 0.7 mg/L) and even lower for the target substance (in water: 0.3 mg/L, in n-Octanol: 0.6 mg/L). These values suggest poor absorption and low bioavailability for both pigments.
The log n-octanol-water partition coefficients were -0.62 and 0.41 for the source and for the target substance respectively. These values are far below the limit of concern considered to be critical for bio-accumulative properties.
The pH value of both pigments is not extreme and therefore gives no reason to assume corrosive properties.
Pigment Red 50:1 showed very limited biodegradability (not readily biodegradable in the 10-day-window and within 28 days), which is assumed to be due to its unavailability for microorganisms.
Poor bioavailability is probably also the reason for the absence of any relevant acute mammalian toxicity. The target pigment was not skin sensitising in the LLNA. Both pigments were not mutagenic in the Bacterial Reverse Mutation Assay neither with nor without S9-mix indicating that metabolic activation is not an issue.
Due to its low solubility and its inertness it can reasonably be assumed that considerable amounts of both pigments are virtually not present in a dissolved form on the skin or mucous membranes after single dermal or oral exposure, i.e. they cannot be absorbed in relevant amounts after single oral application and do not cause local effects after contact with skin or eyes. This reasoning is supported by the outcome of QSAR analyses predicting very low acute oral toxicity (LD50 values above 4000 mg/kg bw.) and the absence of skin and eye irritating properties for both the target and the source substance.
This assessment is based on experimental and QSAR data on the source pigment as compared to available data of the target pigment covering the following endpoints: Specific physicochemical properties, acute oral toxicity, skin and eye irritation/corrosion, skin sensitisation, genotoxicity in vitro, and biodegradability (for details see data matrix below).
In conclusion, the similar structure and the uniformity of physicochemical, environmental fate and toxicological properties justifies the application of read across to predict the outcome of acute oral toxicity and skin/eye irritation/corrosion studies of the target pigment based on existing date coming from the source pigment. Supporting evidence is provided by QSAR analysis predicting consistently a very low acute oral toxicity and the absence of irritating/corrosive properties to skin and eyes.
Data Matrix
CHEMICAL NAME |
C.I. Pigment Red 50:1 |
C.I. Pigment Red 53:1 |
Role |
Target Substance |
Source Substance |
CAS No. |
6372-81-2 |
5160-02-1 |
Physical and Chemical Properties |
||
Physical state of the substance at 20° C and 1013 hPa |
red solid |
red solid |
Melting/freezing point |
Decomp. Temp.: |
Decomp. Temp.: |
Water solubility |
0.25 mg/L |
2.986 mg/L |
n-Octanol solubility |
0.64 mg/L |
0.716 |
log Partition coefficient |
0.41 |
-0.62 |
pH |
6.9 |
5 - 8 |
Environmental Fate and Pathways |
||
Biodegradation in water: screening test |
not readily biodegradable in the 10-d-window and after 28 days |
no experimental data |
Toxicological Information |
||
Skin irritation (in vivo) |
RA-conclusion: |
not irritating |
Skin irritation (QSAR) |
OECD Toolbox: |
OECD Toolbox: |
Eye irritation (in vivo) |
RA-conclusion: |
not irritating |
Eye irritation (QSAR) |
OECD Toolbox: |
OECD Toolbox: |
Skin sensitisation |
not skin sensitising |
no experimental data |
In vitro gene mutation study in bacteria |
not mutagenic |
not mutagenic |
Acute toxicity, oral route, (experimental LD50 mg/kg b.w., rats) |
RA-conclusion: |
> 2000 |
Acute toxicity, oral route (QSAR, LD50 mg/kg b.w.) |
OECD Toolbox: |
OECD Toolbox: |
Justification for selection of skin irritation / corrosion endpoint:
Eperimental data for read across come from the most similar substance available.
Justification for selection of eye irritation endpoint:
Eperimental data for read across come from the most similar substance available.
Justification for classification or non-classification
Based on available data Pigment Red 50:1 was predicted be read across and QSAR analyses to have no skin/eye irritant/corrosive properties. Therefore the test item has not to be classified for skin/eye irritation/corrosion according to Regulation (EC) No 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.