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EC number: 266-867-4 | CAS number: 67674-28-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 19, 1994 to October 13, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- 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:
- Available study information is over 12 years old.
Test material
- Reference substance name:
- Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- EC Number:
- 266-867-4
- EC Name:
- Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- Cas Number:
- 67674-28-6
- Molecular formula:
- C26H25N5O5S.Na
- IUPAC Name:
- sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Acid Red 299
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The albino guinea pig is the recommended species for skin sensitisation studies.
Animal strain: Pirbright White Strain (Tif: DHP)
Breeder: CIBA-GEIGY Limited, Animal Production 4332 Stein, Switzerland
Date of acclimatisation: September 14, 1994
Group Size and Husbandry
The test was performed on 5 male and 5 female guinea pigs in the test group and 5 female guinea pigs in the control group, initially weighing between 358 to 425 g.
The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22 ± 3 °C, at a relative humidity of 30 to 70% and a 12 hours light cycle day.
The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water.
All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer.
The drinking water quality fulfilled the critical parameters in the specifications of the 11 Schweizerisches Lebensmittelbuch 11 (Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to CIBA-GEIGY Limited, as well as the results of in house chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited.
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 potassiumdichromate.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- one administration on day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% in Freund's adjuvant/saline mixture 1:1
- Day(s)/duration:
- one administration on day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50%
- Day(s)/duration:
- day 8/48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 10%
- Day(s)/duration:
- day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 male and 5 female guinea pigs in the test group and 5 female guinea pigs in the control group
- Details on study design:
- Pretests
Intradermal Induction
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest.
The following concentration of test article has been used for intradermal injection:
5% in physiological saline (w/v).
Since 5% FAT 21071/G 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 21071/G have been examined on separate animals for the determination of the maximum subirritant concentration:
10, 20, 30, and 50% in physiological saline.
50% was the highest possible concentration of the test article in physiological saline.
Reactions were observed with 20, 30, and 50% FAT 21071/G in physiological saline.
Test procedure
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 21071/G in physiological saline (w/v)
-5% FAT 21071/G 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
In the test group FAT 21071/G was incorporated in physiological saline and applied on a filte rpaper patch to the neck of the animals (patch 2 x 4 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 21071/G in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 21071/G in physiological saline and on the other flank with the vehicle alone (patch 2 x 2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
Test and control group:
- 10% FAT 21071/G in physiological saline
- physiological saline only
Observations and records
Induction reactions
After removal of the dressing on day 10, irritation of the epidermal application site was observed in 10/10 test group animals.
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. - Challenge controls:
- The vehicle alone was applied to one flank of each animal.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss.
Results and discussion
- Positive control results:
- Number of positive animals per group after occlusive epidermal application
Control group:
after 24 hours after 48 hours
vehicle control 0/10 0/10
test article 0/10 0/10
Test group:
after 24 hours after 48 hours
vehicle control 0/20 0/20
test article 20/20 20/20
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Number of positive animals per group after occlusive epidermal application
Control group: |
|
|
|
After 24 hours |
After 48 hours |
Vehicle control |
0/5 |
0/5 |
Test article |
0/5 |
0/52 |
Test group: |
|
|
|
After 24 hours |
After 48 hours |
Vehicle control |
0/10 |
0/10 |
Test article |
7/10 |
6/10 |
Challenge reactions after epidermal application
(CONTROL GROUP)
DRAIZE Score 24 hours after removal of the dressing
Vehicle control |
|||||
Female animals |
151 |
152 |
153 |
154 |
155 |
Erythema score: Edema score |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Test article control |
|||||
Female animals |
151 |
152 |
153 |
154 |
155 |
Erythema score: Edema score: |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
DRAIZE Score 48 hours after removal of the dressing
Vehicle control |
|||||
Female animals |
151 |
152 |
153 |
154 |
155 |
Erythema score: Edema score |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Test article control |
|||||
Female animals |
151 |
152 |
153 |
154 |
155 |
Erythema score: Edema score: |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Challenge reactions after epidermal application
(TEST GROUP)
DRAIZE Score 24 hours after removal of the dressing
Vehicle control |
|||||
Male animals |
146 |
147 |
148 |
149 |
150 |
Erythema score: Edema score |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Female animals |
156 |
157 |
158 |
159 |
160 |
Erythema score: Edema score: |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Test article control |
|||||
Male animals |
146 |
147 |
148 |
149 |
150 |
Erythema score: Edema score: |
1 1 |
1 0 |
1 1 |
1 0 |
1 1 |
Female animals: |
156 |
157 |
158 |
159 |
160 |
Erythema score: Edema score: |
0 0 |
0 0 |
1 0 |
1 0 |
0 0 |
DRAIZE Score 48 hours after removal of the dressing
Vehicle control |
|||||
Male animals |
146 |
147 |
148 |
149 |
150 |
Erythema score: Edema score |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Female animals |
156 |
157 |
158 |
159 |
160 |
Erythema score: Edema score: |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Test article control |
|||||
Male animals |
146 |
147 |
148 |
149 |
150 |
Erythema score: Edema score: |
1 1 |
1 0 |
1 1 |
0 0 |
1 1 |
Female animals: |
156 |
157 |
158 |
159 |
160 |
Erythema score: Edema score: |
0 0 |
0 0 |
1 1 |
1 1 |
0 0 |
Evaluation of the primary skin irritation potential
Procedure: On each animal 2 concentrations of FAT 21071/G were applied simultaneously on the left and right flank. A naïve skin site served as control.
At least 7 days before application of FAT 21071/G two pairs of intradermal injections of an adjuvant/saline mixture 1:1 (v/v; 0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs.
|
Score 24 hours |
Score 48 hours |
||
|
After removing the dressing |
|||
Concentrations of FAT 21071/G in physiological saline |
||||
Animal No./ Sex |
30% er/ed |
50% er/ed |
30% er/ed |
50% er/ed |
1 male 2 female |
0/0 1/1 |
½ 1/1 |
0/0 0/0 |
1/2 1/1 |
Animal No./ Sex |
10% er/ed |
20% er/ed |
10% er/ed |
20% er/ed |
3 male 4 female |
0/0 0/0 |
1/0 1/0 |
0/0 0/0 |
1/0 1/0 |
er = erythema, ed = edema
Individual animal bodyweights in g
Test group males
Animal No. |
Weight |
|
At start |
At end |
|
146 147 148 149 150 |
425 418 419 377 407 |
574 626 517 507 540 |
Mean Std. Dev. |
409 19.1 |
553 48.3 |
Test group Females
Animal No. |
Weight |
|
At start |
At end |
|
156 157 158 159 160 |
378 358 367 377 406 |
503 449 440 465 529 |
Mean Std. Dev. |
377 18.0 |
477 37.7 |
Control group females
Animal No. |
Weight |
|
At start |
At end |
|
151 152 153 154 155 |
380 401 364 369 409 |
524 563 489 518 539 |
Mean Std. Dev. |
385 19.7 |
527 27.3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the experimental conditions employed, 70% and 60% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.
According to the maximisation grading of Magnusson and Kligman Acid Red 299 showed a moderate to strong grade of skin-sensitising (contact allergenic) potential in albino guinea pigs. - Executive summary:
Body weights were not affected by treatment.
Under the experimental conditions employed, 70% and 60% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.
Acid Red 299, therefore, classified as a moderate to strong sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
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