Registration Dossier

Administrative data

Description of key information

LD50 > 2000 mg/kg b.w.

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 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
other: Royal Decree 363/1995
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 142.6 males, 128.6 females
- Fasting period before study: overnight
- Housing: Tecniplast Makrolon cage (48 x 27 x 20 cm) with soft wood.
- Diet: free access to a diet for experimental rats, supplied by a authorized provider.
- Water: drinking water ad Iibitum by Makrolon bottles.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C (± 2 °C)
- Humidity: 55 % (± 25 %)
- Air changes: 15ACH filtered at 5 µm
- Photoperiod: 12 hours cycle dark/light.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg of test item were dissolved in 20 ml of distilled water.
- Amount of vehicle: 2 ml per 100g b.w, equivalent to 2000 mg/kg b.w.
Doses:
2000 mg/Kg.
No. of animals per sex per dose:
3 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing:at 0, 7 and 14 days.
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
No abnormal behaviour or signs of toxicity were observed.
Gross pathology:
No macroscopic changes were observed.
Interpretation of results:
other: Not classified, accordding to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 > 2000 mg/kg b.w.
Executive summary:

The substance has been tested for acute toxicity by oral dose according to the Directive 67/548/EC B.1 ter, class method.

A limit test at one dose level of 2000 mg/kg body weight was carried out with six animals. No mortality has been observed until 2000 mg/kg b.w, therefore the LD50 is over than 2000 mg/kg b.w.

Conclusion

LD50 > 2000 mg/kg b.w.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Oral exposure:

The study was conducted according to the method described into the Directive EC n. 67/548 Annex IV B. B.1 .ter.

The substance has been tested for acute oral administration by gavage. Six rats (3 males and 3 females) were used for the study at concentration of 2000 mg/kg bw.

No clinical symptoms were recorded and no deaths occurred. During autopsy no macroscopic changes were seen.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

The substance is not capable to produce adverse effects after acute administration by oral route, therefore no classification is warranted.