Registration Dossier
Registration Dossier
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EC number: 291-493-3 | CAS number: 90412-13-8
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- 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
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- 5/mouse/sex were dosed by a single intraperitoneal dose of 2000 mg/kg; observation were carried out for 14 days after dosing.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (U.K.) Ltd.
- Weight at study initiation: 17 - 24 g
- Fasting period before study: for 18 - 20 hours 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 light conditions
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Details on exposure:
- A single intraperitoneal dose (2000 mg/kg) of test material, based on the individual fasted body weight of the animais at the time of treatment.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- 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 were recorded 14 days after treatment.
- Necropsy of survivors performed: no
- Other examinations performed: no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- EC50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- EC0
- 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 gain.
Applicant's summary and conclusion
- Conclusions:
- LD50 > 2000 mg/kg.
- Executive summary:
Method
Acute intraperitoneal toxicity was assessed by dosing 5 mice/sex/dose by intraperitoneal route at dose of 2000 mg/kg. Observations were carried out for 14 days after dosing.
Results
No deaths occurred and no signs of overt toxicity were noted, thus LD50 > 2000 mg/kg.
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