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EC number: 426-840-1 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Delivery of the animals : October, 30, 1996 - Euthanasia of the animals : November 25, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- July 31, 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 426-840-1
- EC Name:
- -
- IUPAC Name:
- tetrasodium 7-[(2,6-difluoropyrimidin-4-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate 7-[(4,6-difluoropyrimidin-2-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid
- Details on test material:
- Identity: Scarlet RN 1165
Appearance : Solid powder, dark-red
Constituent 1
- Specific details on test material used for the study:
- PROTOCOL DEVIATION: the test article classification was omitted at the request of the sponsor.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Chbb:NZW (SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH; Birkendorferstrasse 65; D - 88397 Biberach / Riss
- Age at treatment: 15 weeks
- Weight at study initiation:
body weight at start of acclimatization: male 2.5 kg, females 2.8 kg
body weight at start of treatment: male 2.5 kg, females 2.8-2.9 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet (batch 70/96 and 71/96) ad libitum from Kliba Muhlen AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are included in this report.
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum. Results of bacteriological, chemical and contaminant analyses are included in this report.
- Acclimation period: Four days under laboratory conditions after health examination. Only healthy animals were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): between 40-70 % (values above 70% during cleaning process possible)
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music during the light period
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the test article was applied as delivered by the sponsor
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g/animal (into one eye of each animal)
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 21 days as the treated eyes were not rinsed after instillation days
- Observation period (in vivo):
- Scoring of irritation effects was performed approximatively 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application
- Number of animals or in vitro replicates:
- 3: 1 male (#16) and 2 females (#17 and #18)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: not relevant
SCORING SYSTEM: see page 14 and 15 of the study report
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel I Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #16, #17 & #18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not relevant as scores remain nil
- Irritation parameter:
- iris score
- Basis:
- animal: #16, #17, #18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not relevant as scores remain nil
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #16, #17 & #18
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #16, #17 & #18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- other: Conjunctivae chemosis
- Basis:
- animal: #16 & #18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not relevant as scores remain nil
- Irritation parameter:
- chemosis score
- Basis:
- animal: #17
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #17
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- other: Staining of conjunctivae and sclera
- Basis:
- animal: #16, #17 & #18
- Time point:
- other: 24/48/72h & 7/14/21d
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- IRRITATION
SCARLET RN 1165 showed a primary irritation score of 0.44, when applied to the conjunctival sac of the rabbit eye.
Slight to moderate swelling and slight swelling of the conjunctivae was seen in all animals. These findings were reversible in all animals after 48 hours.
CORROSION
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- VIABILITY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
COLORATION
Irreversible light red staining of the conjunctivae and sclera by the test article was observed, although reversible light red staining of the iris and cornea of all animals was also seen.
BODY WEIGHTS
The body weight of the animals was within the normal range of variability (for results, please refer to the point "Any other information on results incl. tables" hereafter).
Any other information on results incl. tables
EYE IRRITATION SCORES - INDIVIDUAL VALUES
Animal |
Sex |
Cornea opacity |
Iris |
Conjunctivae |
|
Cumul. score |
Mean cumul. score |
Redn. |
Chem. |
||||||
1 hour |
|
|
|
|
|
|
|
16 |
M |
0 |
0 |
- |
2* |
2 |
1.33 |
17 |
F |
0 |
0 |
- |
1 |
1 |
|
18 |
F |
0 |
0 |
- |
1 |
1 |
|
24 hours |
|
|
|
|
|
|
|
16 |
M |
0 |
0 |
1 |
0 |
1 |
1.33 |
17 |
F |
0 |
0 |
1 |
1 |
2 |
|
18 |
F |
0 |
0 |
1 |
0 |
1 |
|
48 hours |
|
|
|
|
|
|
|
16 |
M |
0 |
0 |
0 |
0 |
0 |
0.00 |
17 |
F |
0 |
0 |
0 |
0 |
0 |
|
18 |
F |
0 |
0 |
0 |
0 |
0 |
|
72 hours |
|
|
|
|
|
|
|
16 |
M |
0 |
0 |
0 |
0 |
0 |
0.00 |
17 |
F |
0 |
0 |
0 |
0 |
0 |
|
18 |
F |
0 |
0 |
0 |
0 |
0 |
|
7 days |
|
|
|
|
|
|
|
16 |
M |
0 |
0 |
0 |
0 |
0 |
0.00 |
17 |
F |
0 |
0 |
0 |
0 |
0 |
|
18 |
F |
0 |
0 |
0 |
0 |
0 |
|
14 days |
|
|
|
|
|
|
|
16 |
M |
0 |
0 |
0 |
0 |
0 |
0.00 |
17 |
F |
0 |
0 |
0 |
0 |
0 |
|
18 |
F |
0 |
0 |
0 |
0 |
0 |
|
21 days |
|
|
|
|
|
|
|
16 |
M |
0 |
0 |
0 |
0 |
0 |
0.00 |
17 |
F |
0 |
0 |
0 |
0 |
0 |
|
18 |
F |
0 |
0 |
0 |
0 |
0 |
BODY WEIGHTS
Animal # |
Sex |
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
16 |
male |
2456 |
2507 |
3161 |
17 |
female |
2802 |
1761 |
3670 |
18 |
female |
2813 |
2945 |
3769 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on criteria defined in Regulation (EC) No 1272/2008, SCARLET RN 1165 is classified as Serious eye damage (category 1). Eye irritation test shows persistence of red light staining at the end of the 21 days recovery period which is according to the CLP guideline a reason for Serious eye damage Cat 1 (discoloration of the cornea by a dye substance).
- Executive summary:
The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application.
The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.44 (max. 13).
Swelling and reddening of the conjunctivae was seen in all animals. These findings were reversible after 48 hours.
Irreversible light red staining of the conjunctivae and sclera by the test article was observed, although reversible light .red staining of the iris and cornea of all animals was also seen.
No corrosion was observed at any of the measuring intervals.
The mean values of the scores for each type of lesion, calculated for each animal separately, are the following:
Animal No.
Mean values 24-72 hours
Cornea Opacity
Iris
Conjunctivae
Redness
Chemosis
16, male
0.00
0.00
0.33
0.00
17, female
0.00
0.00
0.33
0.33
18, female
0.00
0.00
0.33
0.00
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