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EC number: 811-858-8 | CAS number: 2149571-68-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 April 2015 - 29 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This valid study was performed at a GLP laboratory in accorance with OECD, EU, USA and Japanese test guielines for the determination of dermal toxicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of temperature daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of temperature daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of temperature daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000), including the most recent revisions.
- Deviations:
- yes
- Remarks:
- Deviations from the maximum level of temperature daily mean relative humidity occurred. Laboratory historical data do not indicate an effect of the deviations. The study integrity was not adversely affected by the deviation.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- EC Number:
- 811-858-8
- Cas Number:
- 2149571-68-4
- Molecular formula:
- C22 H11 N6 O18 S5 .5Na
- IUPAC Name:
- pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- Reference substance name:
- pentasodium 4-amino-3-[(2,4- disulfonatophenyl)diazenyl]-5-hydroxy-6-[(4-nitro-2- sulfonatophenyl)diazenyl]naphthalene-1,7-disulfonate
- IUPAC Name:
- pentasodium 4-amino-3-[(2,4- disulfonatophenyl)diazenyl]-5-hydroxy-6-[(4-nitro-2- sulfonatophenyl)diazenyl]naphthalene-1,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): K1600 black dye and 206474/A
- Physical state: Powder
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Housing: Individually housed in labeled Makrolon cages ontaining sterilized sawdust as bedding material.
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days before start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): 10 hours
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: No data
- % coverage: 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females.
- Type of wrap if used: consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing: After which dressings were removed and the skin cleaned of residual test substance using tap water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight.
- Concentration (if solution) :10 mL/kg body weight.
VEHICLE
- Concentration (if solution): 20 to 200 mg/mL of test substance in vehicle - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males and 5 females, one dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and viability were observed twice daily. Body weights were examined on days 1, 8 and 15.
- Necropsy of survivors performed: yes, at the end of the study.
- Other examinations performed: clinical signs, body weight,organ weights and descriptions of all internal macroscopic abnormalities were
recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Piloerection, ptosis and/or chromodacryorrhoea were noted for one male animal and three female animals on Day 1. Blue staining by the test substance was seen on the treated skin and tail of all animals throughout the observation period. Focal erythema or
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
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Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 value of K1600 black dye in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, K1600 black dye does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments). - Executive summary:
K1600 black dye was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred. Piloerection, ptosis and/or chromodacryorrhoea were noted for one male animal and three female animals on Day 1.
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
No abnormalities were found at macroscopic post mortem examination of the animals.
The dermal LD50 value of K1600 black dye in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, K1600 black dye does not have to be classified and has no obligatory
labelling requirement for acute dermal toxicity according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
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