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EC number: - | CAS number: -
- 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
Acid Red 195 is considered as non-sensitiser.
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:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 92/69/EEC,
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- 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:
- - Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid
- Storage conditions: room temperature
- Validity: October, 1998
- Test material received: November 19, 1993 - Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 324 to 417 g
- Housing: housed individually in Macrolon cages (Type 3)
- Diet: Standard guinea pig pellets- NAFAG No. 845, Gossau SG, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 1 week
SENSITIVITY OF STRAIN
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser , such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassium dichromate
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h light/12 h dark
IN-LIFE DATES: From 14 February, 1994 to April 28, 1994 - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % FAT 20042/D in physiological saline (w/v)
- 5 % FAT 20042/D in the adjuvant/saline mixture (w/v) - Day(s)/duration:
- Test Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Test group:
- 50 % FAT 20042/D in physiological saline - Day(s)/duration:
- Test Day 08
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Test and control group:
- 30 % FAT 20042/D in physiological saline
- physiological saline only - Day(s)/duration:
- Test day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Main test: 10 per sex for the test group and 5 of one sex for controls
- Details on study design:
- RANGE FINDING TEST:
Intradermal Induction
Since 5 % FAT 20042/D in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal Applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 20042/D have been examined on separate animals for the determination of the maximum subirritant concentration.
- 30 and 50 % in physiological saline.
50 % was the highest possible concentration of the test article in physiological saline. Reactions were observed with 50% FAT 20042/D in physiological saline.
MAIN STUDY
DAY 0: INDUCTION, intradermal injections
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % FAT 20042/D in physiological saline (w/v)
- 5 % FAT 20042/D in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
DAY 8: INDUCTION, epidermal application
The application site of all animals was pretreated with 10 % sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. In the test group FAT 20042/C was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours). The control group was treated with the vehicle only.
Test group:
- 50 % FAT 20042/C in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 20042/D in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
Test and control group:
- 30 % FAT 20042/D in physiological saline
- physiological saline only
Observations and records
Induction reactions
After the intradermal and the epidermal induction application skin irritation is normally induced by the adjuvant, the high test article concentration, or the sodium lauryl sulfate pretreatment. Because most of the reactions are treatment related and not test article related, the reactions were generally not described in the results section.
Challenge reactions
Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
General
The body weight was recorded at start and end of the test.
Interpretation of results
The sensitising potential of FAT 20042/D was classified according to the grading of Magnusson and Kligman. According to the guide to the labelling of dangerous substances and the criteria for the choice of sentences indicating particular hazards (R sentences) attributed to dangerous substances (Commission Directive 93/21/EEC, April 27, 1993), a test article was classified as a sensitiser in the case where a positive response was noted in at least 30 % of the animals. - Challenge controls:
- Not available
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Positive control results:
- Twenty out of 20 test animals, were found to have positive reactions after challenge when tested with positive control 2-Mercaptobenzothiazole puriss.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Intradermal Induction: 5 %, epidermal induction: 50 %, challenge (epidermal): 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reference values 03.01.1994
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Intradermal Induction: 5 %, epidermal induction: 50 %, challenge (epidermal): 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reference values 03.01.1994
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Intradermal Induction: 5 %, epidermal induction: 50 %, challenge (epidermal): 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Intradermal Induction: 5 %, epidermal induction: 50 %, challenge (epidermal): 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Intradermal Induction: 5 %, epidermal induction: 50 %, challenge (epidermal): 30 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Intradermal Induction: 5 %, epidermal induction: 50 %, challenge (epidermal): 30 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20042/D is a non-sensitiser.
- Executive summary:
- A guinea pig maximization study was conducted to evaluate the skin sensitisation potential of FAT 20042/D (at ca. 50 % purity) according to OECD Guideline 406 and EU Method B.6. Since 5% FAT 20042/D in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction. Based on the results of a preliminary study, 50 % concentration was selected for epidermal induction, while 30 % concentration was used for epidermal challenge. The main test consisted of 3 phases i.e. intradermal induction on day 0 at 5 % conc., epidermal induction on Day 8 at 50 % conc. and epidermal challenge on Day 21 at 30 % conc. Skin reactions were graded using Draize scoring at 24 and 48 h after removal of dressing at each phase. Under the experimental conditions employed, 15 and 25 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings when challenged. FAT 20042/D is , therefore, classified as a mild sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman. According to the EEC classification criteria (Commission Directive 93/21/EEC , April 27, 1993) FAT 20042/D did not show a skin sensitising (contact allergenic) potential in albino guinea pigs.
Reference
Body weight and body weight gains of the test as well as control animals were found to have not been affected.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation potential of Acid Red 195 was investigated in two in vivo guinea pig maximisation tests.
In the key study, FAT 20042/D (ca. 50 % purity) was evaluated for skin senstisation potential according to OECD Guideline 406 and EU Method B.6. Since 5% FAT 20042/D in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction. Based on the results of a preliminary study, 50 % concentration was selected for epidermal induction, while 30 % concentration was used for epidermal challenge. The main test consisted of 3 phases i.e. intradermal induction on day 0 at 5 % conc., epidermal induction on Day 8 at 50 % conc. and epidermal challenge on Day 21 at 30 % conc. Skin reactions were graded using Draize scoring at 24 and 48 h after removal of dressing at each phase. Under the experimental conditions employed, 15 and 25 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings when challenged. FAT 20042/D is , therefore, classified as a mild sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman. According to the EEC classification criteria (Commission Directive 93/21/EEC , April 27, 1993) FAT 20042/D did not show a skin sensitising (contact allergenic) potential in albino guinea pigs.
The skin sensitisation potential of FAT 20042/C (ca. 80 % purity) was evaluated according to OECD Guideline 406 and EU Method B.6. Since 5% FAT 20042/C in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction. Based on the results of a preliminary study, in the absence of skin reactions, 50 % concentration was selected for epidermal induction and epidermal challenge. The main test consisted of 3 phases i.e. intradermal induction on day 0 at 5 % conc., epidermal induction on Day 8 at 50 % conc. and epidermal challenge on Day 21 at 50 % conc. Skin reactions were graded using Draize scoring at 24 and 48 h after removal of dressing at every phase. In the treated group, 20/20 animals (10/sex) showed no skin reactions at 24 as well as 48 h observations.No unscheduled deaths or changes in body weight were observed during the study period. Hence , based on the above findings, it was concluded that, under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after challenge, hence FAT 20042/C is considered as not a sensitiser.
Based on the above discussion, Acid Red 195 was considered as not a sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data from available studies, Acid Red 195 does not warrant classification for skin sensitisation under the CLP (EC No. 1272/2008) Regulation.
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