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Description of key information

OECD 401: LD50 (oral, rat) > 2000 mg/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:
1981-08-03 to 1981-08-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Only a brief summary of the study is available
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
not further specified
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Hoechst AG, Frankfurt, Germany
-Females (if applicable) nulliparous and non-pregnant: yes
-Weight at study initiation: 180 - 198 g
-Fasting period before study: 16 hours before until up to 2 hours after treatment
-Housing: groupwise
-Diet: ad libitum
-Water: ad libitum

IN-LIFE DATES: From: day 1 To: day 15
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
-Concentration in vehicle: 250 g/L
-Dosing volume: no data
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 f
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days
-Frequency of observations: daily
-Frequency of weighing: weekly
-Necropsy of survivors performed: yes
Statistics:
no data
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All rats survived the observation period
Clinical signs:
No signs of toxicity were seen in dosed rats
Body weight:
The body weight development of the rats was inconspicuous during the study
Gross pathology:
The gross pathological examination revealed no organ alterations

Study design

In this study performed equivalent to OECD GL 401 the test item was tested for acute toxicity in female rats after single oral administration of 5000 mg/kg body weight.

Results

No signs of toxicity and no deaths during the course of the study were seen in dosed rats. The body weight development of the rats was inconspicuous during the study and the gross pathological examination revealed no organ alterations.

Conclusion

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in female rats.

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in female rats.
Executive summary:

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

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 provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification,Lab elling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776.