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EC number: 216-760-3 | CAS number: 1658-56-6
- 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
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- Water solubility
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- Flash point
- Auto flammability
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- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 03 Feb. 2004 to 24 Feb. 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 29 DEC 1992 (92/69/EEC)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate
- EC Number:
- 216-760-3
- EC Name:
- Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate
- Cas Number:
- 1658-56-6
- Molecular formula:
- C20H13N2NaO4S
- IUPAC Name:
- NA
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Granja Cunicola San bernardo, S.L
- Age at study initiation: 9-10 weeks old
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: individually in stainless steel cages (52.0 x 58.0 X 43.0 cm or 45.0 x 59.0 X 37.0 cm) with a grille floor placed on racks.
- Diet: free access to a standard rabbit diet, Panlab 112, (Panlab, S.L., Barcelona, Spain, expiry date: 25.Mar.04, 08.Apr.04 and 10.june.04) which had been analysed by the manufacturer.
- Water: supplied ad libitum, by means of an automatic drinking system or in bottles. The tap water, supplied by Compaña de Aguas de Sabadell, S.A., is analysed periodically for contaminants.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
-Temperature: 19 - 23 °C
-Humidity: 30 - 60 %
-Photoperiod: 12 hours cycle dark/light (7:00 am to 7:00 pm)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g moistened with distilled water before the administration - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours in one animal; 4 hours in the other two animals
- Observation period:
- 14 days
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: the animals were shaved 24 hours before administration using an electric razor. One square test zone, measuring approximately 6.2 cm², was delimited on the shaven intact skin of one side of each animal.
- % coverage: 2.5 x 2.5 cm
- Type of wrap: patches were held close to the body using a microporous and hypoallergenic adhesive tape; a strip of gauze was wrapped around the trunk of the animal and fixed in place with hypoallergenic adhesive tape in order to hold the semiocclusive patch in position.
TEST ITEM ADMINISTRATION
At first only one animal was used, applying three patches simultaneously for 3 minutes, 1 and 4 hours. After each one of these exposure periods, the corresponding bandage and patch were removed.
The test was completed using two other animals, applying a dressing to each one for 4 hours. After this exposure period, the bandages and patches were removed.
REMOVAL OF TEST SUBSTANCE
- Washing: with water and PEG 400
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48, 72 hours, 7 and 14 days
SCORING SYSTEM
Erythema and Eschar Formation
No erythema:0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Initially, three dressing were applied simultaneously to one animal. The first was removed after 3 minutes, the second after 1 hour and the thirs after 4 hours of exposure.
No skin lesions were recorded in the application area, 1 hour after removing the first semiocclusive patch, which was exposed for 3 minutes. No lesions were observed either 24, 48, 72 hours, 7 and 14 days after removing the patch.
Sixty minutes after removal of the patch exposed for 1 hour, well-defined erythema (grade 2) with very slight edema (grade 1) was recorded. Twenty-four hours after removing the patch, the edema remitted completely, and the erythema decreased to very slight erythema (grade 1), which persisted until 48 hours after removing the patch.
No skin lesions were recorded 72 hours, 7 and 14 days after the removal of the patch exposed for 1 hour.
Sixty minutes after removing the patch exposed for 4 hours, well-defined erythema (grade 2), accompanied by very slight edema (grade 1), was observed. After 24 hours, very slight edema (grade 1) persisted, and well-defined erythema (grade 2) developed into very slight erythema (grade 1).
During the observations carried out 48 and 72 hours afier removing the patch, the edema had remitted completely although very slight erythema persisted (grade 1).
No skin alterations were recorded 7 and 14 days after the removal of the patch exposed for 4 hours.
Subsequently, two more animals were used and a dressing with the test item, which was removed after a four-hour exposure, was applied to them.
Sixty minutes after removing the patch exposed for 4 hours, both animals presented well-defined erythema (grade 2), accompanied by very slight edema (grade 1) in one of them, and slight edema (grade 2) in the other one.
Twenty-four, 48 and 72 hours from the removal of the patch, very slight erythema (grade 1) was recorded in both animals.
No skin lesions were recorded in any of the two animals in the observations made 7 and 14 days after removing the patch exposed for 4 hours. - Other effects:
- Clinical signs: the behaviour and physical state of the rabbits were normal throughout the Study.
Any other information on results incl. tables
Overall test results
Aninmal N. (time) | Reaction | 60 min | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days | Mean 24/48/72 |
# 1 | Erythema | 2 | 1 | 1 | 1 | 0 | 0 | 1.00 |
# 2 | Erythema | 2 | 1 | 1 | 1 | 0 | 0 | 1.00 |
# 3 | Erythema | 2 | 1 | 1 | 1 | 0 | 0 | 1.00 |
# 1 | Edema | 1 | 1 | 0 | 0 | 0 | 0 | 0.33 |
# 2 | Edema | 1 | 0 | 0 | 0 | 0 | 0 | 0.00 |
# 3 | Edema | 2 | 0 | 0 | 0 | 0 | 0 | 0.00 |
Reactions animal 1
Aninmal N. (time) | Reaction | 60 min | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days |
1 (3 min) | Erythema | 0 | 0 | 0 | 0 | 0 | 0 |
1 (1 hr) | Erythema | 2 | 1 | 1 | 0 | 0 | 0 |
1 (4 hrs) | Erythema | 2 | 1 | 1 | 1 | 0 | 0 |
1 (3 min) | Edema | 0 | 0 | 0 | 0 | 0 | 0 |
1 (1 hr) | Edema | 1 | 0 | 0 | 0 | 0 | 0 |
1 (4 hrs) | Edema | 1 | 1 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- The substance was found not to be not irritating to the rabbit skin.
- Executive summary:
The degree of primary skin irritation caused by the test item was evaluate in a study performed according to the OECD Guideline No. 404 (2002) and the Method B.4 of European Communities Commission Directive of 31 July 1992 (92/69/EEC). Initially three semiocclusive patches were applied with 0.5 g of test item simultaneously to one animal for 3 minutes, 1 and 4 hours, respectively. A semiocclusive patch with 0.5 g of test item was applied for 4 hours in the other two animals. The observation time points were at 1, 24, 48, 72 hours and 7, 14 days after the administration.
In all animals the mean scores (24/48/72 h) for erythema were 1, while for oedema the mean value was 0.33 in one animal (#1) and 0 in the other two animals (#2 and #3). No skin lesions were recorded in any of the animals during the observations made 7 and 14 days after removing the patch.
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