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Reaction mass of pentasodium 2-[(8-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate and pentasodium 2-[(1-hydroxy-8-{[4-hydroxy-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate
EC number: 943-998-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50, oral, m/f > 5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read across from analogu substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 194 g; females: 192 g
- Fasting period before study: NA
- Housing: 5/cage
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 9.10.1986 To: 23.10.198 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- 25% in deionised water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle (if gavage): 2x10 mL/kg bw with a 30 min interval between both dosages - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- The application volume of 20 ml/kg body weight was administered in two sub-applications of 10 ml body weight in each case at an interval of approx. 30 minutes.
Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs&death: frequently fisrt day; thereafter twice daily
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
- Clinical signs:
- other: As well as unspecific signs of intoxication the animals also exhibited diarrhoea. In addition, red discoloration of the hairless skin was observed. The substance was eliminated via the faeces and the urine, the urine still having a slight red colouration
- Gross pathology:
- Post-mortem examination of the animals killed at the end of the experiment revealed a pink colouration of the connective and fatty tissue, of the pancreas, the bladder, the testes and the uterus.
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.
- Executive summary:
The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
The analogue substance was tested for acute oral toxicity in an in-vivo studies following OECD 401 (NONS dossier, 1988).
For the acute oral toxicity five males and five females of Wistar were dosed and the LD50, m/f > 5000 mg/kg bw.
Based on the read across considerations same results apply to the test item
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:
For Acute toxicity oral route:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be > 5000 mg/kg bw in the chosen reference test, which does not classified the substance.
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