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Administrative data

Description of key information

Acute oral toxicity (similar to OECD TG 401): 2300 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:
November - December, 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Pre-OECD test guideline study and pre-GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Three males and two females of the Sherman-Wistar strain.
- Fasting period before study: 24 hours
- Diet: Free access to food
- Water: Free access to water
- Acclimation period: one week
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.16 mL/kg bw

Doses were administered directly into the stomach by means of a stomach tube. The substance was applied as a 4% solution, the toxicity was converted to 100% substance.


Doses:
1.26, 1.6, 2.0, 2.5 and 3.16 mL/kg bw
No. of animals per sex per dose:
Three males and two females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: No data
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
the LD50 is converted to the pure substance
Effect level:
2 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Confidence limits 2000 - 2600 mg/kg.
Mortality:
1/5 animals died at 2.0 mL/kg bw, 4/5 animals died at 2.5 mL/kg bw and all 5 animals died at 3.16 mL/kg bw.
Clinical signs:
No data.
Body weight:
No data.
Gross pathology:
No data.
Interpretation of results:
other: Not acute harmful.
Remarks:
According to EU CLP Regulation (EC) No. 1272/2008 and its amendments
Conclusions:
The LD50 is 2300 mg/kg bw and based on this result, the substance is not acute harmful. According to GHS the substance needs to be classified for acute oral toxicity category 5 and labelled with H303: May be harmful if swallowed.
Executive summary:

In an acute oral toxicity study performed equivalent to OECD 401 guideline, five groups of rats (three males and two females) were orally exposed to a 4% solution of the substance. When converted to 100% substance the doses were 2 – 3.16 ml/kg bw. The rats were observed for signs of toxicity for a period of 14 days. 1/5 animals died at 2.0 mL/kg bw, 4/5 animals died at 2.5 mL/kg bw and all 5 animals died at 3.16 mL/kg bw, resulting in an LD50 of 2.3 mL/kg bw. This will value will be conservatively converted into 2300 mg/kg bw (In view of the relative density of the substance: 1.125, the LD50 is actually 2588 mg/kg bw). Based on this result, the substance is not acute harmful.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed equivalent to OECD 401 guideline, five groups of rats (three males and two females) were orally exposed to a 4% solution of the substance. When converted to 100% substance the doses were 2 – 3.16 ml/kg bw. The rats were observed for signs of toxicity for a period of 14 days. 1/5 animals died at 2.0 mL/kg bw, 4/5 animals died at 2.5 mL/kg bw and all 5 animals died at 3.16 mL/kg bw, resulting in an LD50 of 2.3 mL/kg bw. This will value will be conservatively converted into 2300 mg/kg bw (In view of the relative density of the substance: 1.125, the LD50 is actually 2588 mg/kg bw). Based on this result, the substance is not acute harmful.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity by the oral route according to EU CLP (EC,1272/2008 and its amendments).

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