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Description of key information

The test substanz is of very low oral acute toxicity with an oral LD50 (rat) of > 16 g/kg bw.

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:
October to November 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Qualifier:
no guideline followed
Principles of method if other than guideline:
Limit Test: Test animals were administered a single dose of 16000 mg/kg bw of test substance.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Strain: Sprague-Dawley, SPF
- Source: W. Gassner, Sulzfeld (Germany)
- Weight at study initiation: females 110-125 g, males 110-135 g (mean) Environmental conditions:
- Feed: R 10 complete feed for rats (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Illumination: 12 hour light/dark rhythm
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 %
Details on oral exposure:
- Single dose after 16 h of fasting, feeding 4 hours after administration
- Volume: 40 ml/kg b.w. (CMC 0.5%)
- Dosage Preparation: 40% suspension in 0.5% CMC
- Concentration: 16 g/kg Kgw
Doses:
16 000 mg/kg b.w. (gavage),
No. of animals per sex per dose:
control group: 5 male and 5 female
dose group: 5 male and 5 female
Control animals:
yes
Details on study design:
- Post dose observation period: 14 days
EXAMINATIONS:
- body weight: before and on days 1, 7, 14 after treatment
- clinical signs: up to 6 hours after treatment, then daily
- gross pathology at the end of investigation
Statistics:
not neccessary
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Mortality:
1 female rat of dose group died between 24h and 48h after administration
Clinical signs:
Control group: Piloerection up to 5 hours after adminstration
Dose group: Piloerection up to 72 hours after adminstration
Signs of toxicity had disappeared after 72 hours.
Body weight:
Dose group: Increase of body weight was affected by the treatment in the first week.
Gross pathology:
no findings
Other findings:
no further information

no further remarks

Conclusions:
In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item is greater than 16000 mg/kg body weight.
Executive summary:

The test item was given to rats by oral administration (40 ml/kg b.w) to obtain information on the toxicity, in particular lethality, of the test item.

The vehicle was administrated to 5 male and 5 female Spague-Dawley rats. Test item was administrated as 40% suspension in CMC (0.5%) oral to 5 male and 5 female Spague-Dawley rats. Dose level of 16000 mg/kg b.w. was employed.

One female rat of dose group died between 24h and 48h after administration.

Animals of control group showed Piloerection up to 5 hours after adminstration, animals of dose group showed Piloerection up to 72 hours after adminstration. There were no signs of toxicity after 72 hours.

The increase of body weight of dose group animals was affected by the treatment in the first week.

Dissection at the end of the experiment showed no findings.

Under the conditions of this study the acute toxicity after oral application is greater than 16000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
16 000 mg/kg bw
Quality of whole database:
The study is valid with restriction (Klimisch 2).

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

Justification for classification or non-classification

Based on the results of the acute oral study and according to the criteria of EC Regulation 1272/2008 the test item has a very low acute toxicity if swallowed (LD50 (rat) > 16 g/kg bw). Therefore, the test substance must not be classified.

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