Registration Dossier
Registration Dossier
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EC number: 419-310-6 | CAS number: 125248-71-7
Endpoint summary
Administrative data
Description of key information
The LD50 value of the test item for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg bw according to OECD Guideline 401.
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
- Study period:
- May 10, 1995 - May 24, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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: F. Winkelmann, 33178 Borchen
- Age at study initiation: about 7 to 10 weeks
- Weight at study initiation: 165 (156 - 174) g
- Fasting period before study: about 1 7 hours before dosing up to 4 hours after treatment
- Housing: housed in individual .Makrolon cages type III (floor area: 37.5 x 21 cm = 787.5 cm2, height: 15 cm) placed an mobile racks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 30 - 51
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous Methocel K4M Premium solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 g/100 mL
- Amount of vehicle: 20 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
DOSAGE PREPARATION: The test material was freshly prepared prior to application with aqueous Methocel K4M Premium solution.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: All rats were weighed before treatment, and on days 2, 4, 6, 8, 11, 13, and 15 of the study. The behaviour and general condition of all rats were monitored for at least 6 hours after the administration and then checked daily.
- Necropsy of survivors performed: yes
- Statistics:
- The body weight data were processed by means of a PC programm.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None.
- Clinical signs:
- other: Only pale feces were observed in all animals on day 2 of the study. Otherwise no signs of intoxication occurred after treatment.
- Gross pathology:
- No organ alterations were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test item for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg bw according to OECD Guideline 401.
- Executive summary:
The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw according to OECD Guideline 401. Only pale feces on day 2 of the study were observed after treatment. No signs of intoxication occurred. Thus, the study was perforemd as limit test. The gross pathological examination revealed no organ alterations.
The lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and Guideline conform study
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
The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw according to OECD Guideline 401. Only pale feces on day 2 of the study were observed after treatment. No signs of intoxication occurred. Thus, the study was perforemd as limit test. The gross pathological examination revealed no organ alterations.
The lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
Based on the available data, the test item is not classified and labelled for acute oral toxicity according to Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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