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Administrative data

Description of key information

In an oral study in rats the LD50 was above 5000 mg/kg bw. There were no adverse effects at this dose.

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, no GLP; short report, females only
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
no data
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 %
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: no data
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
balance disorder and prone position.
feces showed a yellow discoloration
Body weight:
no effects
Gross pathology:
no effects
Other findings:
none
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose (LD50) after single oral administration to female rats is greater than 5000 mg/kg body weight.
Executive summary:

The test substance, a yellow powder, was administered by oral gavage formulated as a 25% suspension in sesame oil at a single dose of 5.000 mg/kg body weight to 10 female SPF-Wistar-rats (strain: Hoe:WISKf (SPF 71) weighing 190-210g (average weight 201g).

The test system with female rats was chosen, because no differences in sensitivity between sexes were found in preliminary studies. Food was withheld from 16 h before to 2 h after dosing.

The observation period following treatment lasted for 14 days. During this time the animals were weighed weekly, and fed with laboratory diet ALTROMIN 1324 (Altromin GmbH, Lage/Lippe) and tap water ad libitum. Animals were kept in plastic cages on woodshaves.

At the end of the observation period the animals were sacrificed after narcotisation, dissected and examined for macroscopically visible changes.

The study was performed between 1 September 1977 and 16 September 1977.

Results:

None of the 10 rats died after dosing 5000 mg/kg body weight. After administration the animals showed balance disorder and prone position. The weight gains during the observation period were normal in all the rats. After administration the excreted feces showed a yellow discoloration. The animals killed at the end of the observation period showed no macroscopically visible changes.

Due to the experimental design an exact determination of the LD 50 was not possible. However the median lethal dose (LD50) after single oral administration to female rats is definitely greater than 5000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
2 reliable with restrictions

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

In an oral study in female Wistar rats the LD50 was above 5000 mg/kg bw. There were no adverse effects at this dose.


Justification for selection of acute toxicity – oral endpoint
onyl available study

Justification for classification or non-classification

no classification

In an oral study in rats the LD50 was above 5000 mg/kg bw. There were no adverse effects at this dose.