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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:
25 June 1987 to 9 July 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Volume 16, Part 1500.30
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid (unspecified)
Details on test material:
- Appearance: Dark blue liquid
- Storage conditions: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 215.5 - 224.0 g (males); 219.5 - 245.7 g (females)
- Fasting period before study: Yes. Food was withheld for an overnight period just before test material administration.
- Housing: Animals were maintained in individual cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Animals were housed in temperature-controlled and humidity-monitored quarters.

IN-LIFE DATES: From: 17 June 1987 To: 9 July 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after test material administration and once daily thereafter for 14 days. Mortality/moribundity were recorded twice daily. All animals were weighed just before test material administration, at Day 7, and at termination, or time of death.
- Necropsy of survivors performed: Yes. At termination, all the surviving animals were sacrificed and necropsied. Necropsies were also performed at time of death. Observations were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Two female rats receiving the 5000 mg/kg dose had died by Day 2. All the remaining animals survived throughout the study.
Clinical signs:
A variety of clinical observations were noted in all the animals. These included soft faeces in two male and four female animals following test material administration and one female was urine stained; depression/slight depression was noted in one female animal on Days 1 and 2; one female was observed to be hunched on Day 1.

All the surviving animals returned to normal by Day 8 and remained normal to Day 14.
Body weight:
Prior to death, the two females that did not survive lost weight, while the surviving animals gained weight.
Gross pathology:
Observable gross pathology findings noted in four females involved the lungs, liver and spleen (discoloration) and the stomach and intestines (distended and abnormal contents). No gross pathology findings were observed in any of the males at time of necropsy.
Other findings:
The test material coloured the faeces and urine of the animals until Day 7.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the LD50 was estimated to be >5000 mg/kg bw in male and female rats.
Executive summary:

The acute oral toxicity potential of the test material was investigated in accordance with the standardised guideline from the Code of Federal Regulations, Volume 16, Part 1500.30.

The test material was administered in distilled water via gavage to 5 male and 5 female albino Sprague-Dawley rats at a limit dose of 5000 mg/kg bw.

Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after test material administration and once daily thereafter for 14 days. Mortality/moribundity were recorded twice daily. All animals were weighed just before test material administration, at Day 7, and at termination, or time of death. At termination, all the surviving animals were sacrificed and necropsied. Necropsies were also performed at time of death. Observations were recorded.

Two female rats receiving the 5000 mg/kg dose had died by Day 2. All the remaining animals survived throughout the study. Prior to death, the two females that did not survive lost weight, while the surviving animals gained weight. A variety of clinical observations were noted in all the animals. All the surviving animals returned to normal by Day 8 and remained normal to Day 14.

Observable gross pathology findings noted in four females involved the lungs, liver and spleen (discoloration) and the stomach and intestines (distended and abnormal contents). No gross pathology findings were observed in any of the males at time of necropsy.

Under the conditions of this study the LD50 was estimated to be >5000 mg/kg bw in male and female rats.