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EC number: 955-780-3 | 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
Skin irritation:
1. The intracutenous injection did not induce any cutenous damage to the skin. A black spot formed on the on back skin disappeared largely during the second day and was completely invisible after 2 days. Hence, the test chemical can be considered to be not irritating to skin.
2. Hence, it was concluded that Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
Eye irritation:
1. Slight erythema was observed in the rabbit eyes which disappeared in 24 hours. No corneal damage was observed. Hence, the test chemical can be considered to be not irritating to eyes.
2. The eye potential of the test chemical was evaluated in rabbits. Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours. Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study report.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- To determine the dermal Irritation/corrosion potential of Tetra sodium 1-acetamido-2-hydroxy-3- (4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate in Sprague Dawley rats
- GLP compliance:
- yes
- Specific details on test material used for the study:
- IUPAC Name: Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
Common Name: C.I. Food Black 1, Brilliant Black 1
Molecular Formula:C28H21N5O14S4.4Na
Molecular Weight: 867.6873 g/mol
Substance Type: Organic
Physical state: Solid
SOURCE OF TEST MATERIAL
- Test Item: Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4)
- Source of test material: Sustainability Support Services (Europe) AB
- Batch No.of test material: FG/15-16/1324
- Manufacturing Date: Aug., 2015
- Expiration date of the lot/batch: July, 2023
- Purity test date: No data
- Consistency: Solid, powder
- Colour: Black
RADIOLABELLING INFORMATION (not applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient Temperature
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item was moistened with distilled water before application.
- Preliminary purification step (if any):No data
- Final dilution of a dissolved solid, stock liquid or gel: No data
- Final preparation of a solid: No data
FORM AS APPLIED IN THE TEST (if different from that of starting material): Paste
OTHER SPECIFICS:
Safety Precautions : Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses). - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females (if applicable) nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 6 – 9 weeks were used.
- Weight at study initiation: The weight ranges of approximately 239.1 to 272.5 grams at initiation of dosing were used.
Body weights at the start :
Male
Mean : 269.94 g (= 100 %)
Minimum : 266.4 g (- 1.31 %)
Maximum : 272.5 g (+ 0.95 %)
Total No. of animals : 5
Female
Mean : 244.56 g (= 100 %)
Minimum : 239.1 g (- 2.23 %)
Maximum : 250.4 g (+ 2.39 %)
Total No. of animals : 5
- Fasting period before study: No data
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.3 degree centigrade.
- Humidity (%): 55.7% to 59.6%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: 30-09-2016 to 15-10-2016 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- (Distilled water)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): No
VEHICLE
- Amount(s) applied (volume or weight with unit):No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data
POSITIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data - Duration of treatment / exposure:
- 24 hrs.
- Observation period:
- 14 days
- Number of animals:
- 10 (5/sex).
- Details on study design:
- TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the total body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.
SCORING SYSTEM: Draize Method.
OTHER OBSERVATIONS
Type and Frequency of Tests, Analyses and Measurements
Viability: Twice daily.
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Overall result:
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days. - Other effects:
- Clinical Signs of Toxicity and Mortality
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Body Weight
Sex : Male
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 9.69% and 16.50% respectively.
Sex : Female
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.02% and 9.12% respectively.
Gross Pathological Findings
Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group. - Interpretation of results:
- other: Not irritating
- Conclusions:
- The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal.
Hence, it was concluded that Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification. - Executive summary:
A study was designed and conducted to determine the dermal reaction profile of the read across substance Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate[CAS:2519 -30 -4] in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment reports
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine the skin irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml 5% solution
- Duration of treatment / exposure:
- no data available
- Observation period:
- no data available
- Number of animals:
- no data available
- Details on study design:
- TEST SITE
- Area of exposure: back skin of rabbits - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No cutaneous damage was observed. A black spot formed on the on back skin disappeared largely during the second day and was completely invisible after 2 days.
- Other effects:
- no data available
- Interpretation of results:
- other: not irritating
- Conclusions:
- The intracutenous injection did not induce any cutenous damage to the skin. A black spot formed on the on back skin disappeared largely during the second day and was completely invisible after 2 days. Hence, the test chemical can be considered to be not irritating to skin.
- Executive summary:
The skin irritation potential of the read across substance Tetrasodium (3E)-6 -amino-4 -oxo-3 -(2 -{7 -sulfinato-4 -[(E)-2 -(4 -sulfonatophenyl)diazen-1 -yl]naphthalen-1 -yl}hydrazin-1 -ylidene)-3,4 -dihydronaphthalene-2,7 -disulfonate (CAS no.: 2118 -39 -0, E.C. no.: 218 -326 -9) was assessed in rabbits. Rabbits were given intracutenous injection of 0.1 ml 5% solution of the test chemical on their back skin and observed for signs of dermal reactions (exact duration of study not mentioned). The intracutenous injection did not induce any cutenous damage to the skin. A black spot formed on the on back skin disappeared largely during the second day and was completely invisible after 2 days.Hence, the test chemical can be considered to be not irritating to skin, as per the CLP criteria .
Referenceopen allclose all
Laboratory Test Item Code :TAS/122/013
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
1 - 5 |
0 - 14 |
0/5 |
Sex : Female
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
6 - 10 |
0 - 14 |
0/5 |
Laboratory Test Item Code :TAS/122/013
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
6 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
ndividual Animal -Clinical Signs of Toxicity and Mortality
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
1 |
0 - 14 |
0 |
2 |
0 - 14 |
0 |
||||
3 |
0 - 14 |
0 |
||||
4 |
0 - 14 |
0 |
||||
5 |
0 - 14 |
0 |
Sex : Female
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
6 |
0 - 14 |
0 |
7 |
0 - 14 |
0 |
||||
8 |
0 - 14 |
0 |
||||
9 |
0 - 14 |
0 |
||||
10 |
0 - 14 |
0 |
Individual Animal - Body Weight and Percent Body Weight Gain (g)
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
1 |
266.4 |
292.3 |
9.72 |
305.0 |
4.34 |
14.49 |
2 |
269.2 |
288.6 |
7.21 |
310.3 |
7.52 |
15.27 |
3 |
270.3 |
296.0 |
9.51 |
315.0 |
6.42 |
16.54 |
4 |
271.3 |
299.4 |
10.36 |
319.6 |
6.75 |
17.80 |
5 |
272.5 |
304.2 |
11.63 |
322.7 |
6.08 |
18.42 |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain Day 7- 14 |
% body weight gain day 0- 14 |
6 |
239.1 |
255.3 |
6.78 |
267.3 |
4.70 |
11.79 |
7 |
242.4 |
250.7 |
3.42 |
258.3 |
3.03 |
6.56 |
8 |
243.5 |
253.8 |
4.23 |
262.4 |
3.39 |
7.76 |
9 |
247.4 |
260.4 |
5.25 |
269.8 |
3.61 |
9.05 |
10 |
250.4 |
264.0 |
5.43 |
276.5 |
4.73 |
10.42 |
Individual Animal - Gross Pathological Findings
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Fate |
Gross Pathological Findings |
1 |
TS |
No abnormality detected |
2 |
TS |
No abnormality detected |
3 |
TS |
No abnormality detected |
4 |
TS |
No abnormality detected |
5 |
TS |
No abnormality detected |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Fate |
Gross Pathological Findings |
6 |
TS |
No abnormality detected |
7 |
TS |
No abnormality detected |
8 |
TS |
No abnormality detected |
9 |
TS |
No abnormality detected |
10 |
TS |
No abnormality detected |
TS = Terminal sacrifice
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- data is from experimental reports of read across subtance
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the eye irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill, Ltd., UK)
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing:The animals were conventionally kept in single cages
- Diet (e.g. ad libitum): appropriate diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data available - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- About 100 mg of the finely powdered test specimen and 100 microliters of a 30% or 3% strength aqueous solution of the test chemical
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- The findings were obtained 1, 24, HS and 72 hours after administration and at the end of the follow-up period of 7 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: no
SCORING SYSTEM: The condition of cornea, iris and conjunctivae according to DRAIZE was assessed. The condition of cornea, iris and conjunctivae according to DRAIZE was assessed (see rating table). All other findings not covered by the DRAIZE scale were also recorded. For evaluation, the DRAIZE grades were used at approximately 24, 48, and 72 hours after application.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein : no data available - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days.
In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours.
Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. - Interpretation of results:
- other: not irritating
- Conclusions:
- The eye potential of the test chemical was evaluated in rabbits. Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours. Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes. - Executive summary:
The eye potential of the read across substance Trisodium 8-hydroxy-1,3,6-pyrenetrisulfonate (CAS no.: 6358-69-6) was evaluated in rabbits. 6 albino rabbits were used for the study. The animals were conventionally kept in single cages and were given an appropriate diet and tap water ad libitum. For each of the 6 rabbits, about 100 mg of the finely powdered test specimen and 100 microliters of a 30% or 3% strength aqueous test chemical solution were applied to the conjunctival sac of one eye. Only animals with intact eyes were used.The untreated eye served as control. The findings were obtained 1, 24, 48 and 72 hours after administration and at the end of the follow-up period of 7 days. The condition of cornea, iris and conjunctivae according to DRAIZE was assessed. Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours. Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours. Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine the eye irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24 hours
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: conjunctival sac - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight erythema was observed in the rabbit eyes which disappeared in 24 hours. No corneal damage was observed.
- Interpretation of results:
- other: not irritating
- Conclusions:
- Slight erythema was observed in the rabbit eyes which disappeared in 24 hours. No corneal damage was observed. Hence, the test chemical can be considered to be not irritating to eyes.
- Executive summary:
The eye irritation potential of the read across substance Tetrasodium (3E)-6 -amino-4 -oxo-3 -(2 -{7 -sulfinato-4 -[(E)-2 -(4 -sulfonatophenyl)diazen-1 -yl]naphthalen-1 -yl}hydrazin-1 -ylidene)-3,4 -dihydronaphthalene-2,7 -disulfonate (CAS no.: 2118 -39 -0, E.C. no.: 218 -326 -9) in rabbits. The undiluted test substance was instilled in conjuctival sac of 2 rabbits at a concentration of 50mg. There was slight erythema observed in the rabbit eyes which disappeared in 24 hours. No corneal damage was observed in any of the animals. Hence, the test chemical can be considered to be not irritating to eyes of rabbits.
Referenceopen allclose all
Table #: Irritant/corrosive response data for neat substance for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/2/1/1/1 |
0/2/1/0/1/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/2/1/1/0/2 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/1/1/0/1 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/1/0/0/0/0 |
0/0/0/0/0/0 |
7 d |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0.6/1.3/0.6/0.6/0.0/1.0 |
0/0/0/0/0/0 |
Area effected |
0/0/0/0/0/0 |
|
|
|
Reversibility*) |
|
|
c. |
c. |
Average time (unit) for reversion |
|
|
7 d |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Judgment is based on mean scores for each animal following grading at 24, 48 and 72 hours after application of the test material, in consideration of reversibility.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
1. The skin irritation potential of the read across substance Tetrasodium (3E)-6 -amino-4 -oxo-3 -(2 -{7 -sulfinato-4 -[(E)-2 -(4 -sulfonatophenyl)diazen-1 -yl]naphthalen-1 -yl}hydrazin-1 -ylidene)-3,4 -dihydronaphthalene-2,7 -disulfonate (CAS no.: 2118 -39 -0, E.C. no.: 218 -326 -9) was assessed in rabbits. Rabbits were given intracutenous injection of 0.1 ml 5% solution of the test chemical on their back skin and observed for signs of dermal reactions (exact duration of study not mentioned). The intracutenous injection did not induce any cutenous damage to the skin. A black spot formed on the on back skin disappeared largely during the second day and was completely invisible after 2 days.Hence, the test chemical can be considered to be not irritating to skin, as per the CLP criteria .
2. A study was designed and conducted to determine the dermal reaction profile of the read across substance Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate[CAS:2519 -30 -4] in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
Eye irritation:
1. The eye irritation potential of the read across substance Tetrasodium (3E)-6 -amino-4 -oxo-3 -(2 -{7 -sulfinato-4 -[(E)-2 -(4 -sulfonatophenyl)diazen-1 -yl]naphthalen-1 -yl}hydrazin-1 -ylidene)-3,4 -dihydronaphthalene-2,7 -disulfonate (CAS no.: 2118 -39 -0, E.C. no.: 218 -326 -9) in rabbits. The undiluted test substance was instilled in conjuctival sac of 2 rabbits at a concentration of 50mg. There was slight erythema observed in the rabbit eyes which disappeared in 24 hours. No corneal damage was observed in any of the animals. Hence, the test chemical can be considered to be not irritating to eyes of rabbits.
2. The eye potential of the read across substance Trisodium 8-hydroxy-1,3,6-pyrenetrisulfonate (CAS no.: 6358-69-6) was evaluated in rabbits. 6 albino rabbits were used for the study. The animals were conventionally kept in single cages and were given an appropriate diet and tap water ad libitum. For each of the 6 rabbits, about 100 mg of the finely powdered test specimen and 100 microliters of a 30% or 3% strength aqueous test chemical solution were applied to the conjunctival sac of one eye. Only animals with intact eyes were used.The untreated eye served as control. The findings were obtained 1, 24, 48 and 72 hours after administration and at the end of the follow-up period of 7 days. The condition of cornea, iris and conjunctivae according to DRAIZE was assessed. Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours. Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours. Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes.
Justification for classification or non-classification
Based on the available data and weight of evidence approach, the test substance did not show any reaction to the skin and eyes of the animals. Hence, the test substance was considered to be not irritating to the skin and eyes.
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