Registration Dossier
Registration Dossier
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EC number: 291-493-3 | CAS number: 90412-13-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- April 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
- Principles of method if other than guideline:
- Acute toxicity in rats assessed in a limit test at dose of 2000 mg/kg by oral route. Observations were continued for up to 14 days.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd.
- Weight at study initiation: 195 - 300 g
- Fasting period before study: 18 - 20 h before treatment
- Housing: in groups of 5 by sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 10 %
- Photoperiod: natural lighting conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw based on the individual fasted body weight of the animals at the time of treatment.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for overt toxicity and mortality at 15 min, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days; body weights of survivors at 7 and 14 days after treatment.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- No signs of overt toxicity.
- Body weight:
- Normal body weight gains.
Group mean body weights in g
day before treatment day 7 day 14
males 231 260(5) 309(5)
females 203 226(5) 249(5)
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD0 = 2000 mg/kg
LD50 > 2000 mg/kg - Executive summary:
Method
Test substance was administered to 5/rat/sex by gavage at dose of 2000 mg/kg. Test animals were observed for 14 days after dosing.
Results
No mortality was recorded, thus LD0 = 2000 mg/kg and LD50 > 2000 mg/kg.
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