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EC number: 237-864-5 | CAS number: 14025-15-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January-February 1985
- 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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Although no guideline is mentioned, the study was carried out according to the old version of the OECD guideline 403 (1981).
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)
- EC Number:
- 237-864-5
- EC Name:
- Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)
- Cas Number:
- 14025-15-1
- Molecular formula:
- C10H12CuN2O8.2Na
- IUPAC Name:
- Copper(2+) ion disodium 2-({2-[bis(carboxylatomethyl)amino]ethyl} (carboxylatomethyl)amino)acetate
- Test material form:
- not specified
- Details on test material:
- Name: Trilon B-CU 15
Test substance no: 84/ 263
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 464, 681, 1000, 1470, 2150 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 890 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 760 - 1 040
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 830 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 610 - 1 120
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Yes, see below
- Clinical signs:
- other: Yes, see below
- Gross pathology:
- Yes, see below
Any other information on results incl. tables
Mortality males:
464 mg/kg: 0%
681 mg/kg: 0%
1000 mg/kg: 60%
1470 mg/kg: 100%
2150 mg/kg: 100%
Mortality females:
464 mg/kg: 0%
681 mg/kg: 20%
1000 mg/kg: 80%
1470 mg/kg: 100%
2150 mg/kg: 100%
Observations in animals that died:
- 681 mg/kg: general congestive hyperaemia, strikingly dark, black-brown kidneys, light bronze-coloured liver, green/black contents in caecum
- 1000 mg/kg: haematin-containing contents in intestines, liver with grey lobular periphery, in some cases confluent
- 1000 -2150 mg/kg: in stomach: suspicion of irritation, blood ulceration, corrosion of the glandubular stomach mucosa, mucosa stained in several cases by test substance; in small intestines contents stained with substance; strikingly liquid coontents in caecum
- 2150 mg/kg: substance-stained urine
Histopathology:
- 681 mg/kg (one animal): panlobular fatty degeneration in liver and renal tubular necroses in cortex and hydropic tubular degeneration in the medulla
- 1000 mg/kg (one animal): acute yellow dystrophy in the liver
Observations in sacrificed animals:
- 464 and 1000 mg/kg: no abnormalities
- 681 mg/kg: enlarged kidneys in 2 males, pale sreen-type pattern, in other animals no abnormalities
Histopathology:
- 681 mg/kg (one animal): nephrocalcinosis in the cortex and medulla of the kidneys, interstitial repair processes, tubular epithelial regeneration
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of this study, the acute oral LD50 value was 890 mg/kg bw in male and female rats combined.
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