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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

No adverse effects were seen in animal studies for skin or respiratory sensitisation. However, literature data report on respiratory allergy, urticaria and eczema observed in workers with a high occupational exposure to reactive dyes


Consequently, it was agreed between members of the ETAD to classify Reactive Black 5 as skin and respiratory sensitiser. This classification has also been applied to Reactive Blue 250 based on the structural similarity and because Reactive Black 5 can arise as by-product during synthesis.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 in section 13
Reason / purpose for cross-reference:
read-across source
Justification for non-LLNA method:
Test was already available
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
blue staining of skin
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
blue staining of skin
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test item is not sensitizing in pirbright white guinea pigs.

Classification: not sensitizing
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17. Nov to 18. Dec 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was already available
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 240 to 334 g
- Housing: group-housing (5/cage)
- Diet: ERKA Nr 8300 ad libitum
- Water: tap water ad libitum
- Acclimation period: ca. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 17. Nov To: 18. Dec 1987
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5% / 0.1 mL per injection
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% / 0.5 mL
Day(s)/duration:
Day 8 for 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% / 0.5 mL
Day(s)/duration:
Day 22 for 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Determination of primary not irritating concentration: 6
Determination of intradermal tolerability: 3
Sentinel group: 5
Control group: 5
Treatment group: 10
Positive control substance(s):
yes
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
blue staining of skin
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
blue staining of skin
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not sensitizing in pirbright white guinea pigs.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

According to EU Guidelines, Reactive Black 5 was not sensitizing in the guinea pig maximization test. However, literature data report on urticaria and eczema observed in workers with a high occupational exposure to reactive dyes


Consequently, it was agreed between members of the ETAD to classify Reactive Black 5 as skin sensitizer.


This classification has also been applied to Reactive Blue 250.

Respiratory sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
respiratory sensitisation
Remarks:
other: in vitro and in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
see read across justification in section 13
Reason / purpose for cross-reference:
read-across source
Results:
Tier 1: Evaluation of Structure-Activity Relationship
Reactive black 5 is positive in Tier 1 level assessment. According to structure analysis and literature is the dye able to react with proteins. The B-sulfatoethyl sulfone group is the precursor to vinyl sulfone which, in turn, reacts with unsaturated carbon bonds via nucleophilic addition.

Tier 2: In Vitro Conjugation to Protein
Positive in Tier 2 assessment. The dye can covalently modify protein to form a potentially immunogenic hapten-carrier complex. The chemical-GPSA molar ratio was 20:1 for Dye-GPSA.

Tier 3: Evaluation of Immunogenicity via Injection
No respiratory reaction. Positive in the ACA test. Only slight increase in antibody titers (IgG). No allergic antibody was detected in sera from the Dye injected animals at the high and mid dose range; minimal allergic antibody was detected at the 6.7*10E-5 M dose.

Tier 4: Evaluation via Inhalation Exposure
Animals exposed to 1, 5, 10, and 100 mg/m³ Dye did not experience any change in pulmonary function during or after inhalation challenge with Dye-GPSA. Animals exposed to 1 and 5 mg/m³ Dye did not produce detectable antibodies. Animals exposed to 10 and 100 mg/m³ Dye did produce IgG and allergic antibodies to Dye-GPSA as measured in the ELISA and PCA tests.

Positive control results:
PA and TDI were positive in Tier 1 to 4
Negative control results:
Phthalic acid was negative in Tier 1 to 3, not tested in Tier 4.
Interpretation of results:
ambiguous
Conclusions:
Reactive Black 5 reacted positive in the skin sensitization test (ACA) and showed a low increase in IgG antibodies. No immediate-onset respiratory reactions were observed when administered intratracheally of in the inhalation test.
Rective black 5 dye has only been implicated as an occupational allergen in one cohort of workers in England (approximately 7% of exposed workers generated allergic antibody to this dye).
Executive summary:

A multi-level approach for evaluating low molecular weight chemicals as respiratory sensitizers is proposed. The approach involves four levels of testing that utilize both in vitro and in vivo methods. Tier 1 evaluates structure-activity information to determine if the chemical can covalently modify carrier molecules. It also includes a literature search to determine if the compound belongs to a family of chemicals that has been reported to induce hypersensitivity. Tier 2 tests the chemical's potential to haptenate carrier molecules (i.e., protein) under in vitro conditions. Positive results in Tiers 1 and 2 lead to testing in a guinea pig injection model to assess chemical immunogenicity (Tier 3). A positive result at this level leads to testing in a guinea pig inhalation model to address questions about relevant routes of chemical exposure and allergenicity (Tier 4). Tier 4 results are used in determining safe chemical exposure levels. We have evaluated three chemicals using this scheme: phthalic anhydride, reactive black b dye, and toluene diisocyanate. All three have reactive groups and haptenate protein in vitro. They induce a humoral immune response when injected into guinea pigs at equimolar concentrations, and they sensitize animals via inhalation exposure. The severity of the response (antibody titer and respiratory reactivity) can be used to rank-order the chemicals in terms of allergenic "potency." The data indicate that this approach can detect chemical allergens and can be used to characterize them as moderate or strong respiratory sensitizers.

Endpoint:
respiratory sensitisation: 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 in section 13
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
According to the European Discussion Group of Inhalation Toxicologists (EDIT) referring to Botham P.A., Rattray N.J., Woodcock D.R., Walsh S.T. and Hext P.M. "The induction of respiratory allergy in guinea-pigs following intradermal injection of trimellitic anhydride: a comparison with the response to 2,4-dinitrochlorobenzene ", Toxicology Letters, Volume 47, Issue 1, April 1989, Pages 25-39
Results:
Determination of the tolerance of intradermal injections:
Intradermal injection of 30% Remazol-Schwarz B in physiological saline caused encrustations and beginning necrosis at the application sites. Slight induration was observed after injection of the 5% formulation. The injection sites treated with 1% Remazol - Schwarz B showed no signs of irritation. Based on these results a 5% solution was chosen for intradermal induction at day 1.

Determination of the primary non-irritant aerosol concentration:
A slight increase in respiratory rate occurred during exposure to approx. 200 mg/mg air. No marked changes in respiratory rate were observed during exposure to approx. 160 mg Remazol-Schwarz B/m³. Therefore this concentration was chosen for inhalation exposure at challenge day 22.

Body weight gain and clinical signs:
The intradermal injections caused encrustations and indurations of the injection sites up to day 8 at the study. Body weight gains were not impaired.

Challenge treatment
– Lung function parameters
Questionable up to slight changes in the respiratory pattern were observed in all animals after onset of exposure. No significant differences were present between the animals of the material control groups and the animals of the test groups.
Based on the results of the present study Remazol-Schwarz B did not cause a significant allergic response after intradermal induction and respiratory challenge.

- Clinical signs of intoxication
No clinical signs of intoxication were observed.

- Autopsy findings
Autopsy of the animals revealed red patches on the lungs in one animal of each group, respectively.
Positive control results:
-
Negative control results:
-
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the present study the substance did not cause a significant allergic response after intradermal induction and respiratory challenge.
Executive summary:

The test substance was tested for respiratory sensitization in Pirbright White guinea pigs. Induction was carried out by intradermal injection of 0.1 ml (5% solution in physiological saline) at day 1. Animals were challenged at day 22 with approx. 140 - 210 mg/m3 air. Evaluation of the particle size distribution revealed a mass median aerodynamic diameter (MMAD) of 1.8 micrometers and a geometric standard deviation of 1.9. The respiratory pattern changed slightly in some animals during challenge on day 22, but there were no marked differences between the animals induced with the test substance and control animals, which received isotonic saline only on the day of induction. Based on the results of the present study the test substance did not cause a significant allergic response after intradermal induction and respiratory challenge.

Endpoint:
respiratory sensitisation
Remarks:
other: in vitro and in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles
Principles of method if other than guideline:
Tier 1: - evaluation of structure-activity information to determine if the chemical can covalently modify carrier molecules
- literature search to determine if the compound belongs to a family of chemicals that has been reported to induce hypersensitivity
Tier 2: testing for the chemical's potential to haptenate carrier molecules under in vitro conditions
Tier 3: testing in a guinea pig injection model to assess chemical immunogenicity
Tier 4: testing in a guinea pig inhalation model to address questions about relevant routes of chemical exposure and allergenicity.
Tier 4 results were used to determine safe chemical exposure levels.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Char1es River, Portage
- Age at study initiation: -
- Weight at study initiation: 350 to 400 g
- Housing: -
- Diet: Purina Guinea Pig Chow ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
Route of induction exposure:
other: subcutaneous, inhalation
Route of challenge exposure:
other: subcutaneous, intratracheal and inhalation
Vehicle:
olive oil
Concentration:
Induction: 6.7*10E-3 M, 6.7*10E-4 M, 6.7*10E-5 M
Intratracheal challenge: 500 µg/mL conjugate
Inhalation sensitization: 1, 5, 10, 100 mg/m³ Dye aerosol
No. of animals per dose:
Tier 3: 10/group
Tier 4: 8/group
Details on study design:
RANGE FINDING TESTS: yes, with PA

MAIN STUDY - Tier 3
A. INDUCTION EXPOSURE - SC
- No. of exposures: 8
- Exposure period: 4 weeks
- Test groups: 3 per substance
- Control group: 1 vehicle group, 1 phthalic acid (6.7*10E-4 M)
- Site: subcutaneous
- Frequency of applications: 2/week
- Duration: 4 weeks
- Concentrations: 6.7*10E-3 M, 6.7*10E-4 M, 6.7*10E-5 M


B. CHALLENGE EXPOSURE - SC
- No. of exposures: 1
- Day(s) of challenge: 1 week after induction period
- Exposure period: 1 week
- Test groups: 3 per substance
- Control group: 1 group/chemical, 1 phthalic acid
- Site: SC
- Dose: 400 µL
- Evaluation (after challenge): serum collection: 7 days
respiratory evaluation: 8 days
skin reaction: 10 days

C. CHALLENGE EXPOSURE - Intratracheal
- No. of exposures: 1
- Day(s) of challenge: -
- Exposure period: 1 week
- Test groups: 3 per substance
- Control group: 1 group/chemical, 1 phthalic acid
- Site: tracheal bifurcation
- Dose: 100 µL
- Concentrations: 500 µg/mL
- Evaluation (after challenge): visual: immediately for 10 minutes
Active cutaneous anaphylaxis (ACA) testing: 48 hr


MAIN STUDY - Tier 4
A. INDUCTION EXPOSURE
- No. of exposures/exposure period: 3 hr/day for 5 consecutive days
- Test groups: 4 for Reactive black 5
- Control group: 1 air controlled
- Site: inhalation (whole body plethysmographs)
- Frequency of applications: daily
- Duration: 5 days; 3 hr/day
- Concentrations: 1, 5, 10, 100 mg/m³ Dye aerosol


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after induction period
- Exposure period: 30 minutes
- Test groups: 4 for Reactive black 5
- Control group: 1 air controlled
- Site: inhalation (whole body plethysmographs)
- Evaluation (after challenge): respiratory rate and breath peak height: continuously monitored (before and during challenge)

OTHER:
Passive cutaneous anaphylaxis (PCA) testing
ELISA
Challenge controls:
yes
Positive control substance(s):
phthalic anhydride
toluene diisocyanate (TDI)
Negative control substance(s):
other: phthalic acid
Results:
Tier 1: Evaluation of Structure-Activity Relationship
Reactive black 5 is positive in Tier 1 level assessment. According to structure analysis and literature is the dye able to react with proteins. The B-sulfatoethyl sulfone group is the precursor to vinyl sulfone which, in turn, reacts with unsaturated carbon bonds via nucleophilic addition.

Tier 2: In Vitro Conjugation to Protein
Positive in Tier 2 assessment. The dye can covalently modify protein to form a potentially immunogenic hapten-carrier complex. The chemical-GPSA molar ratio was 20:1 for Dye-GPSA.

Tier 3: Evaluation of Immunogenicity via Injection
No respiratory reaction. Positive in the ACA test. Only slight increase in antibody titers (IgG). No allergic antibody was detected in sera from the Dye injected animals at the high and mid dose range; minimal allergic antibody was detected at the 6.7*10E-5 M dose.

Tier 4: Evaluation via Inhalation Exposure
Animals exposed to 1, 5, 10, and 100 mg/m³ Dye did not experience any change in pulmonary function during or after inhalation challenge with Dye-GPSA. Animals exposed to 1 and 5 mg/m³ Dye did not produce detectable antibodies. Animals exposed to 10 and 100 mg/m³ Dye did produce IgG and allergic antibodies to Dye-GPSA as measured in the ELISA and PCA tests.

Positive control results:
PA and TDI were positive in Tier 1 to 4
Negative control results:
Phthalic acid was negative in Tier 1 to 3, not tested in Tier 4.
Interpretation of results:
ambiguous
Conclusions:
Reactive Black 5 reacted positive in the skin sensitization test (ACA) and showed a low increase in IgG antibodies. No immediate-onset respiratory reactions were observed when administered intratracheally of in the inhalation test.
Rective black 5 dye has only been implicated as an occupational allergen in one cohort of workers in England (approximately 7% of exposed workers generated allergic antibody to this dye).
Executive summary:

A multi-level approach for evaluating low molecular weight chemicals as respiratory sensitizers is proposed. The approach involves four levels of testing that utilize both in vitro and in vivo methods. Tier 1 evaluates structure-activity information to determine if the chemical can covalently modify carrier molecules. It also includes a literature search to determine if the compound belongs to a family of chemicals that has been reported to induce hypersensitivity. Tier 2 tests the chemical's potential to haptenate carrier molecules (i.e., protein) under in vitro conditions. Positive results in Tiers 1 and 2 lead to testing in a guinea pig injection model to assess chemical immunogenicity (Tier 3). A positive result at this level leads to testing in a guinea pig inhalation model to address questions about relevant routes of chemical exposure and allergenicity (Tier 4). Tier 4 results are used in determining safe chemical exposure levels. We have evaluated three chemicals using this scheme: phthalic anhydride, reactive black b dye, and toluene diisocyanate. All three have reactive groups and haptenate protein in vitro. They induce a humoral immune response when injected into guinea pigs at equimolar concentrations, and they sensitize animals via inhalation exposure. The severity of the response (antibody titer and respiratory reactivity) can be used to rank-order the chemicals in terms of allergenic "potency." The data indicate that this approach can detect chemical allergens and can be used to characterize them as moderate or strong respiratory sensitizers.

Endpoint:
respiratory sensitisation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11. Aug to 21. Oct. 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Principles of method if other than guideline:
According to the European Discussion Group of Inhalation Toxicologists (EDIT) referring to Botham P.A., Rattray N.J., Woodcock D.R., Walsh S.T. and Hext P.M. "The induction of respiratory allergy in guinea-pigs following intradermal injection of trimellitic anhydride: a comparison with the response to 2,4-dinitrochlorobenzene ", Toxicology Letters, Volume 47, Issue 1, April 1989, Pages 25-39
GLP compliance:
yes
Species:
guinea pig
Strain:
other: Pirbright-White (HOE DHPK (SPFLac))
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 to 5 weeks
- Weight at study initiation (mean): males: 250 g; females: 243 g
- Housing: groups of 4 animals
- Diet: Altromin 3112 ad libitum
- Water: tap ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 30 to 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11-Aug-1993 To: 21-Oct-1993
Route of induction exposure:
intradermal
Route of challenge exposure:
inhalation
Vehicle:
other: intradermal: NaCl
Concentration:
males: 150, 210 mg/m³
females: 140, 180 mg/m³
No. of animals per dose:
Determination of the tolerance of intradermal injections: 2 animals
Determination of the primary non-irritant concentration (inhalation): 4 animais
Material Control Group: 8 animals
Test Group: 8 animals
Details on study design:
Animals of the test groups are treated intradermally with the test substance: 0.1 mL 1%, 5%, 30%
Animals of the material control groups are treated with the vehicle only.
Determination of the primary non irritant aerosol concentration: 30 to 200 mg/m³
All animals are challenged by inhalation after three weeks using a primary non irritating concentration of the test substance.
Allergic reactions in the test groups are assessed by changes of lung function parameters compared to the material control groups.
Challenge controls:
yes
Positive control substance(s):
not specified
Negative control substance(s):
not specified
Results:
Determination of the tolerance of intradermal injections:
Intradermal injection of 30% Remazol-Schwarz B in physiological saline caused encrustations and beginning necrosis at the application sites. Slight induration was observed after injection of the 5% formulation. The injection sites treated with 1% Remazol - Schwarz B showed no signs of irritation. Based on these results a 5% solution was chosen for intradermal induction at day 1.

Determination of the primary non-irritant aerosol concentration:
A slight increase in respiratory rate occurred during exposure to approx. 200 mg/mg air. No marked changes in respiratory rate were observed during exposure to approx. 160 mg Remazol-Schwarz B/m³. Therefore this concentration was chosen for inhalation exposure at challenge day 22.

Body weight gain and clinical signs:
The intradermal injections caused encrustations and indurations of the injection sites up to day 8 at the study. Body weight gains were not impaired.

Challenge treatment
– Lung function parameters
Questionable up to slight changes in the respiratory pattern were observed in all animals after onset of exposure. No significant differences were present between the animals of the material control groups and the animals of the test groups.
Based on the results of the present study Remazol-Schwarz B did not cause a significant allergic response after intradermal induction and respiratory challenge.

- Clinical signs of intoxication
No clinical signs of intoxication were observed.

- Autopsy findings
Autopsy of the animals revealed red patches on the lungs in one animal of each group, respectively.
Positive control results:
-
Negative control results:
-
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the present study Remazol-Schwarz B did not cause a significant allergic response after intradermal induction and respiratory challenge.
Executive summary:

Remazol-Schwarz B was tested for respiratory sensitization in Pirbright White guinea pigs. Induction was carried out by intradermal injection of 0.1 ml Remazol-Schwarz B (5% solution in physiological saline) at day 1. Animals were challenged at day 22 with approx. 140 - 210 mg Remazol-Schwarz B / m3 air. Evaluation of the particle size distribution of Remazol-Schwarz B aerosol revealed a mass median aerodynamic diameter (MMAD) of 1.8 micrometers and a geometric standard deviation of 1.9. The respiratory pattern changed slightly in some animals during challenge on day 22, but there were no marked differences between the animals induced with Remazol-Schwarz B and control animals, which received isotonic saline only on the day of induction. Based on the results of the present study Remazol-Schwarz B did not cause a significant allergic response after intradermal induction and respiratory challenge.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

According to EU Guidelines, Reactive Black 5 was not sensitizing in an inhalative guinea pig sensitization test performed according to the European Discussion Group of Inhalation Toxicologists (EDIT) (referring to Botham P.A., Rattray N.J., Woodcock D.R., Walsh S.T. and Hext P.M. "The induction of respiratory allergy in guinea-pigs following intradermal injection of trimellitic anhydride: a comparison with the response to 2,4-dinitrochlorobenzene ", Toxicology Letters, Volume 47, Issue 1, April 1989, Pages 25-39). However, literature data report on symptoms of respiratory allergy observed in workers with a high occupational exposure to reactive dyes.


 


Consequently, it was agreed between members of the ETAD to classify Reactive Black 5 as respiratory sensitizer.


This classification has also been applied to Reactive Blue 250.

Justification for classification or non-classification

No adverse effects were seen in animal studies for skin or respiratory sensitisation. However, literature data report on respiratory allergy, urticaria and eczema observed in workers with a high occupational exposure to reactive dyes


Consequently, it was agreed between members of the ETAD to classify Reactive Black 5 as skin and respiratory sensitizer.


This classification has also been applied to Reactive Blue 250.