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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 277-040-2 | CAS number: 72927-99-2
- 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
The source substance is non-irritant to rabbit skin but is severely irritating to rabbit eyes.
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:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- FAT 41001/C
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation:12 - 14 weeks
- Weight at study initiation: 2320-2560 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): Water were provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±3
- Humidity (%): 30-70
- Air changes (per hr):approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 males
- Details on study design:
- SCORING SYSTEM:
The index of primary cutaneous irritation was calculated as follows:
- the scores obtained for erythema and edema at 1 hour, 24, 48 and 72 hours after removal of the patch, on the 3 rabbits examined, are summed up
- the sums of total edema and erythema were divided by 12 when all the animals survived.
- the score obtained is defined as the "index of primary cutaneous irritation". - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The animals showed a normal body weiqht development.
No other reactions to treatment were recorded durinq the whole observation period. - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It can be concluded that the test substance is not an irritant or corrosive when applied to the rabbit skin according to GHS criteria; there was a clear tendency of recovery towards the end of the observation period.
- Executive summary:
Acute dermal skin irritation/corrosion study in the rabbits was carried out according to OECD guideline 404.
According to the criteria of the study, the test substance was slightly irritant with an overall irritation score of 0.66. According to GHS criteris, the test substance is not an irritant or corrosive when applied to the rabbit skin, There was a clear tendency of recovery towards the end of the observation period.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- FAT 41001/D
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation:12 - 14 weeks
- Weight at study initiation: 2000-2260 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): Water were provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±3
- Humidity (%): 30-70
- Air changes (per hr):approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 females
- Details on study design:
- SCORING SYSTEM:
After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, (cf. Table 1), after 1, 24, 48, 72 hours and during the following observation period.
The score obtained is defined as the "index of primary cutaneous irritation".
INDEX CLASSIFICATION
<0.5 non irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 irritant
5.1 - 8.0 severely irritant - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0.33
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: only 1 animal could be assessed due to strong colouring of the skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The animals showed a normal body weight development.
As in two of three rabbits scoring was not possibile due to intensive blue staining by the test compound, the scoring was performed according the values for edema only. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- It can be concluded that the test substance is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
- Executive summary:
Acute dermal skin irritation/corrosion study in the rabbits was carried out in accordance with OECD guideline 404. The animals showed a normal body weight development.
As in two of three rabbits scoring was not possibile due to intensive blue staining by the test compound, the evaluation was performed with the values for edema only.
It can be concluded that the test substance is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Blue 049, where the sulphonate group is bound at the meta-position of the aminobenzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Blue 049.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Blue 49 meta/para (CAS# 72214-18-7 / EC# 276-481-8)
Target: Reactive Blue 49 meta (CAS# 72927-99-2 / EC# 277-040-2)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.2 Melting point / freezing point - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- no
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0.33
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: only 1 animal could be assessed due to strong colouring of the skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The animals showed a normal body weight development.
As in two of three rabbits scoring was not possibile due to intensive blue staining by the test compound, the scoring was performed according the values for edema only. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- It can be concluded that the test substance is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
- Executive summary:
Acute dermal skin irritation/corrosion study in the rabbits was carried out in accordance with OECD guideline 404. The animals showed a normal body weight development. As in two of three rabbits scoring was not possibile due to intensive blue staining by the test compound, the evaluation was performed with the values for edema only. It can be concluded that the test substance is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
The structurally related target substance will show the same behaviour and will therefore be non-irritant to skin as well.
Referenceopen allclose all
None
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Blue 049, where the sulphonate group is bound at the meta-position of the aminobenzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Blue 049.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Blue 49 meta/para (CAS# 72214-18-7 / EC# 276-481-8)
Target: Reactive Blue 49 meta (CAS# 72927-99-2 / EC# 277-040-2)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.2 Melting point / freezing point - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- In two rabbits the eyes were recovered after 21 days. In one rabbit slight reddening and cornea turbidity was still observed on Day 21.
- Other effects:
- The animals showed a normal body weight development.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item showed irritating effects to eyes when applied to the rabbit eye mucosa
- Executive summary:
In a test performed according to OECD test guideline 405, the test substance was assessed for eye irritation potential. Three male rabbits were treated with 0.1 g of test mateial and observed over 21 days. Under the conditions of the present experiment the test substance was found to be severely irritant when applied to the rabbit eye mucosa.
The structurally related target substance will show the same behaviour and will therefore be classified as a severe eye irritant.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- FAT 41001/C
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: ca 2 kg
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum):Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%):30-70
- Air changes (per hr): 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Application of the test article:
0.1 ml of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as the control.
SCORING SYSTEM:
The irritating and/or corrosive potential of the test article (theoretical range: non-irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The animals showed a normal body weight development.
No other reactions to treatment were recorded during the whole observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to GHS criteria, the liquid formulation of Reactive Blue 49 (meta/para) was not irritating to the rabbit eye.
- Executive summary:
Under the conditions of the present experiment the test susbtance was not irritant and not corrosive when applied to the rabbit eye mucosa according to CLP criteria. All effects seen, were recoved after 72 hours.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- FAT 41001/D
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation:1800-1990 g
- Weight at study initiation:12 - 14 weeks
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±3
- Humidity (%):30-70
- Air changes (per hr):approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light):12 hours light/day - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
The irritating and/or corrosive potential of the test article (theoretical range: non-irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- In two rabbits the eyes were recovered after 21 days. In one rabbit slight reddening and cornea turbidity was still observed on Day 21.
- Other effects:
- The animals showed a normal body weight development.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item showed irritating effects to eyes when applied to the rabbit eye mucosa
- Executive summary:
In a test performed according to OECD test guideline 405, the test substance was assessed for eye irritation potential. Three male rabbits were treated with 0.1 g of test mateial and observed over 21 days.
Under the conditions of the present experiment the test substance was found to be severely irritant when applied to the rabbit eye mucosa.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The following information is available for the source substance:
A key study was carried out to determine the acute dermal skin irritation/corrosion potential in the rabbits in accordance with OECD guideline 404. The animals showed a normal body weight development.
It can be concluded, that Reactive Blue 49 (purity: 78.8%) is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
A supporting study was carried out to determine the acute dermal skin irritation/corrosion potential in the rabbits according to OECD guideline 404.
Under the conditions of the present experiment, the liquid preparation of Reactive Blue 49 (purity: 26.1 % AS.) was found to be slightly irritant and not corrosive when applied to the rabbit skin according to the study criteria. There was a clear tendency of recovery towards the end of the observation period of 7 days. The calculated dermal irritation index was 0.66. According to GHS criteria, the test substance is not irritating.
A key study was carried out to determine the acute eye irritation/corrosion potential in the rabbits in accordance with OECD guideline 405. Severe eye effects were seen during the study. In two rabbits all signs of irritation were reversed after the 21 day observation period. One rabbit eye still showed slight reddening and cornea opacity on Day 21. Under the conditions of the present experiment Reactive Blue 49 (purity: 78.8%) was found to cause irreversible eye damage when applied to the rabbit eye mucosa.
Under
the conditions of the present supporting study the liquid preparation of Reactive
Blue 49 (purity:
26.1
% AS)
was found to be slightly irritant and not corrosive when applied to the
rabbit eye mucosa. There was a clear tendency of recovery towards the
end of the observation period of 7 days.
Justification for classification or non-classification
The source substance is non-irritant to rabbit skin but is severely irritating to rabbit eyes. It is anticipated that the structurally related target substance will show the same behaviour. Therefore it will be classified according to CLP with Eye Dam 1 H318.
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.