Registration Dossier
Registration Dossier
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EC number: 279-091-6 | CAS number: 79135-90-3
Endpoint summary
Administrative data
Description of key information
In an oral study in rats the acute LD50 was above 5000 mg/kg bw. No mortality occurred.
No further studies available.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well performed and documented guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: KFM-Han. Wistar, SPF-quality
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Mauderin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 154 - 192 g (males); 153 - 168 g (females)
- Fasting period before study: overnight
- Housing: Macrolon cages (type 3) in groups of five
- Diet: peletted standard Kliba 24/343/1 rat maintenance diet (Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland); ad libitum
- Water: tap water; quality according to Schweiz Lebensmittelbuch; ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
- Room air conditioned - Route of administration:
- oral: gavage
- Vehicle:
- other: 2 % aqueous solution of carboxymethylcellulose, sodium salt
- Details on oral exposure:
- VEHICLE
- a dilution of the test compound was prepared using a homogenizer (Ultra-Turrax) and kept homogenous during treatment using a magnetic stirrer
- Application volume: 10 mL/kg bw at 1000 mg/kg bw; 20 mL at 5000 mg/kg bw - Doses:
- 1000 mg/kg bw
5000 mg/kg/bw - No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: five times at day 1; daily during days 2 - 14
- Frequency of weighing: on test days 1, 7 and 14
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animals died within the 14 day observation period
- Mortality:
- no deaths occurred during the study
- Clinical signs:
- other: slightly developed effects were observed in both sexes: sedation and exophthalmos on day 1; dyspnoea and curved body position until day 5 and ruffled fur until day 10.
- Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was administered orally to Wistar rats of both sexes at doses of 1000 mg/kg bw and 5000 mg/kg bw. No deaths were observed during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.
- Executive summary:
Male and female rats were subjected to test acute oral toxicity according to OECD TG 401. The test item was administered at dose leves of 1000 mg/kg bw and 5000 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period no animals died and there were no ab normalities found in necropsy, thus leading to an LD50 > 5000 mg/kg bw.
Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- reliable with restriction (outdated guideline)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification
In an oral study in rats the acute LD50 was above 5000 mg/kg bw. No mortality occurred.
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