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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 274-437-2 | CAS number: 70210-40-1
- 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
Reactive Red 65 is classified as a strong sensitizer in albino guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 12, 1981
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: EEC directive 79/83
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 80158.32
- Expiration date of the lot/batch: April 1990
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under storage conditions: guaranteed by the sponsor - Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Remarks:
- Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: In-house breeding
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: 328 - 439 g
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets - NAFAG No.846, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 h light cycle day
IN-LIFE DATES: From: 15-10-1985 To: 25-11-1985 - Route:
- intradermal
- Vehicle:
- other: Intradermal application: Test compound FAT 40062/B in physiological saline Test compound FAT 40062/B in the adjuvant saline mixture Adjuvant and saline mixture (1:1) Epidermal application: Vaseline
- Concentration / amount:
- 1 % / 0.1 ml
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 10 % / 0.4 g in vaseline
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 0.3% / 0.2 g
- Day(s)/duration:
- Two weeks after the epidermal induction
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (Intradermal and Epidermal)
- Exposure period: Intradermal : 1 week and Epidermal: 48 h
- Test groups: 1
- Site: neck of the animals
- Frequency of applications:
- Duration: 48 h
- Concentrations: 0.4 g paste of 10 % test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 48 h (2 days)
- Exposure period: 24 h
- Test groups: 10 males and 10 females
- Control group: yes
- Site: flank
- Concentrations: 0.2 g paste of 0.3 % test substance in vaseline
- Evaluation (h after challenge): 48 h - Challenge controls:
- A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
- Positive control substance(s):
- no
- Positive control results:
- Not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g of 0.3 % test substance
- No. with + reactions:
- 18
- Total no. in group:
- 19
- Clinical observations:
- Erythema, Edema, body weight
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g of 0.3 % test substance
- No. with + reactions:
- 9
- Total no. in group:
- 19
- Clinical observations:
- Erythema, edema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 ml
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 ml
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- FAT 40062/B showed a moderate to strong grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.
- Executive summary:
A GPMT test was performed to determine the contact allergenic potency of FAT 40062/B in albino guinea pigs. The test was carried out according to the maximization test of Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969, Cont. Dermatitis 6, 46-50, 1980), recommended in the OECD guideline 406, adopted May 12, 1981 and in the EEC directive 79/83 The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. Two weeks after the epidermal induction application the animals were tested on the flank with FAT 40062/B in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 h). The incidence of positive animals per group and the individual challenge reactions and the individual animal weights at start and end of the test are observed and recorded. Under the experimental conditions employed, 45-95 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings. After 24 h challenge 9/sex rabbits showed erythema while 2 male and 3 female showed edema. However, after 48 h challenge 3 male and 5 female rabbit showed erythema while 2 female rabbit showed edema. Animal No.342 died during the rest period between induction and challenge. The death of the animal was unrelated to the test compound application. There were no adverse effects were seen on body weight. FAT 40062/B is therefore classified as a strong sensitizer in albino guinea pigs according to the grading of Magnusson and Kligman.
Reference
DRAIZE Score 24 hours after removal of the dressings: Test Compound
Male animals |
341 |
342 |
343 |
344 |
345 |
346 |
347 |
348 |
349 |
350 |
Erythema Score |
1 |
+ |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Edema Score |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema Score |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
Edema Score |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
DRAIZE Score 24 hours after removal of the dressings: Control
Male animals |
341 |
342 |
343 |
344 |
345 |
346 |
347 |
348 |
349 |
350 |
Erythema Score |
0 |
+ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
DRAIZE Score 48 h after removal of the dressings: Test Compound
Male animals |
341 |
342 |
343 |
344 |
345 |
346 |
347 |
348 |
349 |
350 |
Erythema Score |
0 |
+ |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema Score |
0 |
1 |
0 |
1s |
1 |
0 |
0 |
0 |
1 |
1 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
DRAIZE Score 48 h after removal of the dressings: Control
Male animals |
341 |
342 |
343 |
344 |
345 |
346 |
347 |
348 |
349 |
350 |
Erythema Score |
0 |
+ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A GPMT test was performed to determine the contact allergenic potency of FAT 40062/B in albino guinea pigs. The test was carried out according OECD guideline 406. The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. Two weeks after the epidermal induction application the animals were tested on the flank with FAT 40062/B in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 h).
After 24 h challenge 9/sex rabbit showed erythema while 2 male and 3 female showed edema. However, after 48 h challenge 3 male and 5 female rabbit showed erythema while 2 female rabbit showed edema. Animal No.342 died during the rest period between induction and challenge. The death of the animal was unrelated to the test compound application. There were no adverse effects were seen on body weight.
FAT 40062/B is therefore classified as a strong sensitizer in albino guinea pigs according to the grading of Magnusson and Kligman.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation
- Type of information:
- other: 3rd party hazard and risk assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from Handbook or collection of data
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Data from Handbook or collection of data.
- GLP compliance:
- no
- Interpretation of results:
- sensitising
- Conclusions:
- Reactive Red 065, CAS 70210 -40 -1, EC 274 -437 -2 is recommended to be labelled as a respiratory sensitizer by ETAD based on international experience gained in handling this dye.
- Executive summary:
Reactive Red 065, CAS 70210 -40 -1, EC 274 -437 -2 is recommended to be labelled as a respiratory sensitizer by ETAD based on international experience gained in handling this dye.
Reference
ETAD guidance - Labelling of reactive dyes
Respiratory sensitization potential of some Reactive dyes:
Appropriate MSDS information and hazard labelling
ETAD has addressed the concerns that a small percentage of reactive dyes have caused respiratory sensitisation. Based on available knowledge, the possibility that other reactive dyes may also cause respiratory sensitisation cannot be excluded. Because there is at present no suitable animal test system for respiratory sensitisation, ETAD recommends the following:
For all Reactive dyes
1. Safety data sheet
Information should be given of the possible respiratory sensitisation effects of reactive dyes of all classes. It is the responsibility of each company to determine how this information should be given in accordance with the regulatory requirements in the various countries.
2. Labelling
Good working practice requires that Reactive dyes, as indeed all dyes, should be handled carefully to minimise worker exposure. The product label should therefore include a safety phrase that breathing of dust (for solid formulations) or spray (for liquid formulations) should be avoided.
In the European Union the appropriate S-phrases must be used, i.e.
S22 do not breathe dust
S23 do not breathe spray
In the Globally Harmonized System the Precautionary statements for Prevention and Response advice must be used:
Precautionary statements:
Prevention: Avoid breathing dust and spray
Response: If respiratory symptoms occur, seek medical advice
For listed Reactive dyes
There is evidence that certain Reactive dyes have caused respiratory sensitisation in workers occupationally exposed to them. These dyes are listed in the table. For these dyes, and any others which are concluded, on individual assessment, to cause respiratory sensitisation this hazard should be indicated on the safety data sheet and product label.
In the European Union the following symbols and phrases must be used.
For solid formulations:
Xn (harmful)
R42 may cause sensitisation by inhalation
S22 do not breathe dust
For liquid formulations:
Xn (harmful)
R42 may cause sensitisation by inhalation
S23 do not breathe spray
In the Globally Harmonized System these dyes have to be classified as Respiratory Sensitizers
Hazard Category 1
Signal word Danger
Symbol GHS08
Hazard statements:
H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled
Precautionary statements:
P 261 - Avoid breathing dust / mist… (according Physical form of formulation)
P 285 – In case of inadequate ventilation wear respiratory protection
The substance Reactive Red 065, CAS 70210 -40 -1, EC 274 -437 -2 is listed in the "List of Reactive dyes to be classified as respiratory sensitizers" page 31 ff. within that document. Labelling as a respiratory sensitizer is recommended.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Justification for classification or non-classification
Based on the findings in the skin sensitisation study the Reactive Red 65 should be classified as skin and respiratory sensitiser according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) 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.