Registration Dossier
Registration Dossier
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reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
EC number: 429-070-4 | CAS number: 214362-06-8 SCARLET DER 8107
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Sep 1998 to 13 Nov 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Section 4, Number 402 "Acute Dermal Toxicity", adopted February 24, 1987.
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/CEE, B.3
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
- EC Number:
- 429-070-4
- EC Name:
- reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
- Cas Number:
- 214362-06-8
- Molecular formula:
- C26H(25-y-x)KyN5NaxO16S5 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO22S7
- IUPAC Name:
- octapotassium octasodium 7-amino-4-hydroxy-3,8-bis(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3,8-bis(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-3-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test item name: Reactive Brown 49
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TVR50
- Expiration date of the lot/batch: 01-SEP-2004
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature (approx. 20 °C) away from direct sunlight.
- Stability of the test substance in the vehicle: Stable in bi-distilled water for at least 24 h
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanIbm (Wistar)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:RCC Ltd, Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8 - 10 weeks; Females: 11 - 12 weeks
- Weight at study initiation: Males : 261 - 274g ; females :202 - 243 g
- Housing: Groups of five in Makrolon type-4 cages with standard softwood bedding. During treatment and observation individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 3433, batch no. 25/98 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum. Results of analyses for contaminants are archived at RCC.
- Water: Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC.
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C) : 21 - 23
- Humidity (%) : 38 - 66
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12-h artificial fluorescent light, 12-h dark cycle
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- bidistilled water
- Details on dermal exposure:
- Approximately 24 h before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. Only those animals without injury or irritation on the skin were used in the test.
On test day 1, the test article was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Application volume/kg body weight: 4.0 ml. Twenty-four h after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Statistics:
- No statistical analysis was used as no deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male and female: 0
- Clinical signs:
- other: No clinical signs of toxicological relevance were noted during the daily observations in rats of both sexes except the red coloration on the skin was produced by the test item itself, described as a dark red/brown powder. The red coloration did not preven
- Gross pathology:
- No effects on organs were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of FAT 40'571/A after single dermal administration to rats is greater than 2000 mg/kg body weight.
- Executive summary:
An acute dermal semi-occlusive toxicity study was carried out with FAT 40571/A in Wistar rats of both sex according to OECD 402 guideline. During study period clinical signs, body weight, mortality and gross pathologicala findings were determined. No clinical signs of toxicological relevance were noted during the daily observations in rats of both sexes except the red coloration on the skin was produced by the test item itself, described as a dark red/brown powder. The red coloration did not prevent the assessment of the skin: a maculated erythema was seen in one female. However, an inflammatory response was delayed to later time period by developing crusts in most of the male and female animals after a 24- h semi-occlusive application. The crusts were transient in 2 males and persisting up to the end of the study in one male and in four females. Clinical signs such as red skin (5/5), crusts (3/4), maculate erythema (0/1) respectively.
Three female animals showed a very slight loss of body weight during the first week of observation. They recovered during the second week of observation. The body weight of the other animals was within the range commonly recorded for animals of this strain and age.
There was no mortality find during the study course. There were no gross pathological findings observed.
So, based on the study results and absence of mortality the median lethal dose (LD50) of FAT 40'571/A after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight
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