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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Justification for type of information:
Justification for read across is detailed in the report attached to the IUCLID section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to
Guideline:
other: Real Decree 363/1995 and Real Decree 1078/93
Principles of method if other than guideline:
Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation
GLP compliance:
no
Remarks:
Centre certificated ISO 9001 by National Accreditation Program (N. 98-1101)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: authorized provider.
- Health: rats were submitted to a sanitary control.
- Age at study initiation: young and healthy rats
- Housing: 3 rats for every cube of Makrolon (48 x 27 x 20 cm) by Tecniplast, with bed of woodchip. Each cube has been signed by label.
- Diet: free access to specific fodder for experimental rat, supplied by authorized provider
- Water: tap water ad libitum by Makrolon bottle
- Acclimatation period: 7 days

Before starting test each rat was marked by black pen on tail

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 25
- Air changes (per hr): 15 air changes by pre-filtration of 5 µm
- Photoperiod (hrs dark / hrs light): 12/12 by timer

OTHER
Materials used:
Balance: COBOS D 6000-SX
Vinyl/latex Gloves
Syringes of 1 and 2 ml

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
PREPARATION/ADMINISTRATION OF TEST SUBSTANCE:
2000 mg of test substance were dissolved in 20 ml of water.
Administration: 2 ml/100 g of body weight. Forced administration by metallic cannula, after a fasting night.
Since 3 hours after administration, the regular diet was recovered
Doses:
25, 200 and 2000 mg/Kg bw
No. of animals per sex per dose:
3 per 3 per dose
Control animals:
not specified
Details on study design:
- Administration: oral administration by metallic probe
- Duration of observation period following administration: 14 days
- Frequency of observations: In the first day frequent observations, and then, once every working day
- Sacrifice: yes by CO2 inhalation or cervical dislocation
- Necropsy performed: yes, macroscopic
- Body weight: performed at the start of the study, before substance administration, at 7 days after administration and at the end of the study.
- General examination: skin, fur, eyes, mucose, respiratory system, cardiovasculary system, central and periheral nervous system, somatomotor system and behaviour. A particular attention was given to tremors, convulsions, salivation, diarrhea, letargia, sleep and coma.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality at 2000 mg/Kg bw was observed.
Clinical signs:
No abnormalities were observed during the test period
Body weight:
Normal body weight variation
Gross pathology:
No abnormalities were observed
Other findings:
No abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 oral rat > 2000 mg/Kg bw.
Executive summary:

The susbtance was tested for oral acute toxicity according to the Real Decree 363/1995, that is the transposition of Directive 67/548/EEC in Spanish legislation. The LD50 value is > 2000 mg/kg.