Registration Dossier

Toxicological information

Acute Toxicity: oral

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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:
other: Relatively well reported study. No GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
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
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Name: Trilon B-CU 15
Test substance no: 84/ 263

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:
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:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the acute oral LD50 value was 890 mg/kg bw in male and female rats combined.