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Description of key information

ACUTE ORAL
LD50 >5000 mg/kg bw; male/female rat; CFR Volume 16, Part 1500.30

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The study was conducted on a read-across material in accordance with a standardised guideline and was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997). It is considered that this, along with the high LD50, ensures that the study addresses this endpoint in a valid fashion. The quality of the database is therefore considered to be good.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to acute oral toxicity.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to acute oral toxicity.