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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, before GLP, short report, that contains the main details of the performed test, limited substance data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
controls included, high dose and application volume
GLP compliance:
no
Remarks:
pre-dates GLP-regulation
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Alizarinlichtblau HRL
IUPAC Name:
Alizarinlichtblau HRL
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous gum tragacanth (0.5%)
Details on oral exposure:
prepared as a 20% suspension in aqueous gum tragacanth (0.5%) and administered by oral intubation at a dosage volume of 25 ml/kg bodyweight
Doses:
0 (control) or 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
lethargy, piloerection, diuresis, diarrhoea and a slight increase in salivation. Blue stained urine and faeces were observed from all rats.
Body weight:
normal development
Gross pathology:
no relevant findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose (LDso) to rats of the test item was found to be: greater than 5000 mg/kg bodyweight.
Executive summary:

Rats of the CFY strain, in the weight range 140 to 186 g were starved overnight before treatment with the test item.

The test item was prepared as a 20% suspension in aqueous gum tragacanth (0.5%) and administered by oral intubation at a dosage volume of 25 ml/kg bodyweight.

Rats treated with the vehicle alone (25 ml/kg) served as controls.

During the observation period of 14 days, a record was kept of all signs of toxicity. All rats were sacrificed terminally and examined macroscopically in an attempt to identify any target organs.

RESULTS

Ten rats (five male and five female) were treated with the test item at a dosage level of 5000 mg/kg bodyweight .

There were no mortalities.

Signs of reaction to treatment, observed shortly after dosing, consisted of lethargy, piloerection, diuresis, diarrhoea and a slight increase in salivation. Blue stained urine and faeces were observed from all rats. Recovery of all animals, as judged by external appearance and behaviour, was apparently complete within four days of treatment.

Bodyweight gains of all rats were within normal limits and terminal autopsy findings were normal.

CONCLUSION

The acute median lethal oral dose (LD50) to rats of the test item was found to be: greater than 5000 mg/kg bodyweight.

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