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reaction mass of Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2- hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, disodium salt and Benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]ethenyl]-, disodium salt
EC number: 942-661-6 | 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
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- Endpoint summary
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From August 24th to September 06th, 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted according to internationally accepted testing guidelines and performed in compliance with Good Laboratory Practice. Justification for read across approach is given in the endpoint summary and in the read across justification report attached to the Section 13 of this dossier.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- April 29, 2004
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH Stolzenseeweg 32-36 D-88353 Kisslegg / Germany.
- Age at study initiation: 11-12 weeks (male); 10-11 weeks (females).
- Weight at study initiation: 1687 - 2454 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 (batch no. 35/05, Provimi Kliba AG) were provided for gnawing.
- Diet: pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 34/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: community tap water from Füllinsdorf, ad libitum.
- Acclimation period: under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: ranges for room temperature 17-23 °C.
- Humidity: 30-70 %
- Air changes: approximately 10-15 air changes per hour.
- Photoperiod: animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark.
- Other: music was played during the daytime light period.
Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at testing laboratory.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST ITEM PREPARATION
0.5 g (per animal) of the test item was weighed as delivered by the Sponsor and then moistened with approximately 0.5 ml of purified water before application.
The pH of the test item was measured before the study initiation date. A formulation of a 1 % (w/w) solution was prepared. The pH was found to be 8.07. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 (animals of both sexes were used)
- Details on study design:
- As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 4-hour exposure, the test was completed using the two remaining animals for an exposure period of four hours.
TEST SITE
- Area of exposure: four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
- Type of wrap if used: on the day of treatment, 0.5 g of test item was placed on a surgical gauze patch (ca. 4 cm x 4 cm). The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site. The test item could not be removed completely, so that remnants were still present at the 1-hour reading in all animals. However, any reactions (erythema) were clearly visible at that time.
- Time after start of exposure: 4 hours.
OBSERVATIONS
- Viability/Mortality: daily from acclimatization of the animals to the termination of test.
- Clinical signs: daily from acclimatization of the animals to the termination of test.
- Body weights: at start of acclimatization, on the day of application and at termination of observation.
NECROPSY
No necropsy was performed on the animals sacrificed at termination of observation.
All rabbits were sacrificed by an intravenous injection of Vetanarcol into the ear vein at a dose of at least 1 ml/kg body weight (equivalent to 162 mg sodium pentobarbitone/kg body weight) and discarded.
SCORING SYSTEM
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, approximately 1, 24, 48 and 72 hours, as well as 7 days after the removal of the dressing, gauze patch and test item.
If evident, corrosive or staining properties of the test item were described and recorded.
Grading of Skin Reactions
ERYTHEMA AND ESCHAR FORMATION
No erythema: 0
Very slight erythema: 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading: 4
OEDEMA FORMATION
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (edges raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 28 and 72 hrs
- Score:
- < 2.3
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 28 and 72 hrs
- Score:
- < 2.3
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.67, 1.00 and 1.33, respectively and the mean oedema score was 0.00 for all three animals, respectively.
Well-defined to very slight erythema was noted in all animals from the 1- to the 48-hour reading and very slight erythema persisted in two animals up to the 72-hour observation.
Very slight swelling was observed in two animals at the 1-hour reading.
Scaling was present in one animal at the 72-hour reading.
No abnormal findings were observed on the treated skin of any animal 7 days after treatment, the end of the observation time.
COLORATION
No staining produced by the test item of the treated skin was observed.
CORROSION
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
SKIN IRRITATION SCORES
Animal N. | Sex | Reaction | Evaluation interval | Mean 24, 48 and 72 hrs | ||||
1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | ||||
19 | M | Erythema | 2 | 1 | 1 | 0 | 0 | 0.67 |
20 | F | Erythema | 2 | 1 | 1 | 1 | 0 | 1.00 |
21 | F | Erythema | 2 | 2 | 1 | 1 | 0 | 1.33 |
19 | M | Oedema | 1 | 0 | 0 | 0 | 0 | 0.00 |
20 | F | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 |
21 | F | Oedema | 1 | 0 | 0 | 0 | 0 | 0.00 |
19 | M | Scaling | 0 | 0 | 0 | 0 | 0 | |
20 | F | Scaling | 0 | 0 | 0 | 0 | 0 | |
21 | F | Scaling | 0 | 0 | 0 | X | 0 |
x = scaling present
INDIVIDUAL FINDINGS
ANIMAL N. 19, MALE | ANIMAL N. 20, FEMALE | ANIMAL N. 21, FEMALE | |
After 1 hour | Erythema: well-defined erythema Oedema: very slight swelling Flaking: no abnormal findings noted Staining: no abnormal findings noted Other: remnants of the test item present |
Erythema: well-defined erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted Other: remnants of the test item present |
Erythema: well-defined erythema Oedema: very slight swelling Flaking: no abnormal findings noted Staining: no abnormal findings noted Other: remnants of the test item present |
After 24 hours | Erythema: very slight erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: very slight erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: well-defined erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
After 48 hours | Erythema: very slight erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: very slight erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: very slight erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
After 72 hours | Erythema: no abnormal findings noted Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: very slight erythema Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: very slight erythema Oedema: no abnormal findings noted Flaking: scaling present Staining: no abnormal findings noted |
After 7 days | Erythema: no abnormal findings noted Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: no abnormal findings noted Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Erythema: no abnormal findings noted Oedema: no abnormal findings noted Flaking: no abnormal findings noted Staining: no abnormal findings noted |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU
- Conclusions:
- not irritating
- Executive summary:
The primary skin irritation potential of the substance was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7 days after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.67, 1.00 and 1.33, respectively and the mean oedema score was 0.00 for all three animals, respectively.
The application of test item to the skin resulted in mild signs of irritation. These included erythema, oedema and scaling. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. The test item caused no staining of the treated skin, but could not be removed completely by washing with lukewarm water at the removal of the dressing, so that remnants were still present at the 1-hour reading in all animals. However, any reactions (erythema) were clearly visible at that time. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.
Conclusion
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.
In conclusion, the test item does not meet the criteria ti be classified as irritating, according to the CLP (EC 1272/2008) Regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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