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Registration Dossier
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EC number: 949-050-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In the acute oral toxicity study, the LD50
was determined to be 1666 mg/kg bw for male/female.
Based on the criteria in the Regulation CE n.1272/2008, the tested
substance needs to be classified as Acute Tox. Cat. 4.
No study available for dermal and inhalation toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: experimental data on similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH
- Age at study initiation: 9-12 weeks
- Weight at study initiation: males: 195-265 g; females: 173-218 g
- Housing: 5 animals per Makrolon cage type III
- Diet (e.g. ad libitum): pellets of Kliba 343 ad libitum
- Water (e.g. ad libitum): tap water from Itingen, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 -70
- Air changes (per hr): 10/15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- MAXIMUM DOSE: 20 ml at 5000 mg/kg bw (group 5)
RATIONALE FOR SELECTION OF DOSES:Oral administration has been proven to be an efficacious method to assess the test article absorption. - Doses:
- Group 1: 10 ml at 750 mg/kg bw
Group 2: 10 ml at 1000 mg/kg bw
Group 3: 10 ml at 2000 mg/kg bw
Group 4: 20 ml at 3000 mg/kg bw
Group 5: 20 ml at 5000 mg/kg bw - 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 clinical observations: 4 times in day 1; daily during days 2-15
- Frequency of weighing: before application, after 8 days and after 15 days.
- Necropsy of survivors performed: yes, all animals - Statistics:
- The LOGIT-Model (COX, Analysis of Binary Data, London 1977) was applied to estimate the toxicity value. Additionally, the 90, 95 and 99% confidence intervals for the toxicity for each sex the slope of the concentration response line were estimated.
- Preliminary study:
- N.A.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 053 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 439 - < 4 878
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 336 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 934 - < 1 859
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 666 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 344 - < 2 147
- Mortality:
- Based on the values indicated in Appendix A1:
No mortality at 750 and 1000 mg/kg bw.
1 animal died at day 2 for 2000 mg/kg bw
5 animals died at day 2 for 3000 mg/kg bw
5 animals died at day 2 for 5000 mg/kg bw - Clinical signs:
- The following symptoms were observed:
750 mg/kg bw: dyspnea
1000 mg/kg bw: sedation, dyspnea, curved body position, ruffled fur
2000 mg/kg bw: sedation, dyspnea, curved body position, ruffled fur, ataxis (females)
3000 mg/kg bw: sedation, dyspnea, curved body position, ruffled fur, ataxis
5000 mg/kg bw: sedation, dyspnea, curved body position, latero-abdominal position, ventral body position, ruffled fur, ataxis - Body weight:
- No effects on the body weight were noted.
- Gross pathology:
- In killed rats, no pathologic changed were observed.
In dead animals some changes were observed (stomach and intestine descoloration, mottled lungs and discoloration, spleen and kidney discoloration. - Other findings:
- N.A.
- Interpretation of results:
- other: Acute Toxicity Category 4
- Conclusions:
- In this acute oral toxicity study, the LD50 was determined to be 1666 mg/kg bw for male/female.
- Executive summary:
In this acute oral toxicity study, the LD50 was determined to be 1666 mg/kg bw for male/female.
Based on the criteria in the Regulation CE n.1272/2008, the tested substance needs to be classified as Acute Tox. Cat. 4.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 666 mg/kg bw
- Quality of whole database:
- Good report
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
In the acute oral toxicity study, the LD50
was determined to be 1666 mg/kg bw for male/female.
Based on the criteria in the Regulation CE n.1272/2008, the tested
substance needs to be classified as Acute Tox. Cat. 4, H302.
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