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EC number: 602-676-8 | CAS number: 12237-27-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June-August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- C.I. Solvent Red 119
- EC Number:
- 602-676-8
- Cas Number:
- 12237-27-3
- Molecular formula:
- C32H22N10O8Cr
- IUPAC Name:
- C.I. Solvent Red 119
- Reference substance name:
- Unknown impurities
- Cas Number:
- not available
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- olive oil
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- In compliance wih study plan.
Results and discussion
- Preliminary study:
- No
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- 0
- Clinical signs:
- other: 0
- Gross pathology:
- n.a.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item Solvent Red 119 is greater than 2000 mg/kg body weight after single oral
administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD
Guideline 423 it can be concluded that the test item Solvent Red 119 is classified in Category
5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single
oral administration to Wistar rats. - Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item Solvent Red 119
when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.
Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of
2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test itemrelated
mortality was not observed during 24 hours and therefore in a next step 3 females were treated
with the same dose. All 6 females survived the limit dose. The limit dose of 2000 mg/kg body weight
did not cause death or evident signs of toxicity.
Stagnation of body weight in one animal between the first and second week was observed. During
necropsy, no macroscopic findings were observed.
The LD50 of the test item Solvent Red 119 is greater than 2000 mg/kg body weight after single oral
administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD
Guideline 423 it can be concluded that the test item Solvent Red 119 is classified in Category
5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single
oral administration to Wistar rats.
Summary Results
The test item Solvent Red 119 was administered to 6 females at a limit dose of 2000 mg/kg. This
dose did not produce any adverse changes in body weight, and did not cause any increase in mortality.
Stagnation of body weight in 1 animal between the first and second week was observed.
No signs of toxicity were observed at the dosage of 2000 mg/kg during the first 4 hours in females or
the 14-day observation period thereafter. During necropsy, no macroscopic findings were observed.
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