Registration Dossier
Registration Dossier
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EC number: 239-471-4 | CAS number: 15454-74-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Bis(5-oxo-L-prolinato-N1,O2)copper
- EC Number:
- 239-471-4
- EC Name:
- Bis(5-oxo-L-prolinato-N1,O2)copper
- Cas Number:
- 15454-74-7
- Molecular formula:
- C10H12CuN2O6
- IUPAC Name:
- bis(5-oxo-L-prolinato-N1,O2)copper
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: Iffa Credo
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation: 177 +/- 3 g for males and 148 +/- 3 g for females
- Fasting period before study: 18 hours before treatment
- Housing: 4 or 7 animals/ sex during acclimatation and 5 animals/sex during study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50+/- 20 %
- Air changes (per hr): non recycle but filtered with absolute filters
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Lot/batch no. (if required): 1279
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose. Some doses with only one sex.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
clinical signs: every hours after treatment then at least once a day until termination
mortality: at least twice a day
- Necropsy of survivors performed: yes
- Other examinations performed:
body weight: just before treatment and at Day 5, 8 and 15
organ weights: no
histopathology: no macroscopic findings was observed consequently, no histological exam was performed
Results and discussion
- Preliminary study:
- A prelimiminary study showed >50% of mortality at 2000 mg/kg bw, 4 doses has been established to assess LD50 in males: 500, 700, 980 and 1400 mg/kg bw for males and 2 doses in females: 700, 980 mg/kg bw
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 980 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- > 700 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality in males: 0% at 500 mg/kg bw; 0% at 700 mg/kg bw; 60% at 980 mg/kg bw; 60% at 1400 mg/kg bw and 40% at 2000 mg/kg bw
Mortality in females: 20% at 500 mg/kg bw; 20% at 980 mg/kg bw and 100% at 2000 mg/kg bw - Clinical signs:
- The clinical signs observed were a decrease in spontaneous activity for a certain period (from 4 hours to 3 days) relating to the dose administered. Piloerection was recorded after 1 to 4 hours at 700 and 980 mg/kg bw or after 1 to 48 hours at 1400 mg/kg bw.
Dyspnea was noted after one hour in 1 animal at 1400 mg/kg bw.
A reddish vaginal discharge was seen after 24 hours in 2 females at 700 mg/kg bw.
Swelling of the face was observed after 4 and 6 hours in the males at 2000 mg/kg bw.
No clinical sign was observed after 6 hours at 500 mg /kg bw, afer 24 hours in the males at 700 mg/kg bw, after 48 hours in the males at 2000 mg/kg bw, after 72 hours in the surviving females at 700 mg/kg bw and the surviving animals at 980 and 1400 mg/kg bw. - Body weight:
- The body weight gain of the animals was normal between D-1 and D-5 after administration of 500 and 700 mg/kg bw and had decreased slightly after administration of 980, 1400 and 200 mg/kg bw. The body weight gain was normal in all the surviving animales between D-5 and D-15
- Gross pathology:
- The macroscopic examination revealed no abnormalities in the animals found dead during the study or sacrificed at the end of the study
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under test conditions, test item is classified Acute oral tox. cat.4, H302 (CLP regulation)
- Executive summary:
According to a GLP study following TG OECD 401 (1987), 700 > LD50 < 2000 mg/kg bw, a CLP classification Acute oral tox. cat.4, H302 is proposed
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