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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test conducted according to internationally accepted testing procedures and according to the GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Italia.
- Age at study initiation: no more than three months old.
- Weight at study initiation: 276-298 g (males) 223-225 g (females).
- Fasting period before study: 16 hours fasting before treatment.
- Housing: 5 animals/cage/sex.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C
- Humidity: 55 %
- Air changes: 12/20 per hrs, filtered on HEPA 99.97 %.
- Photoperiod: 12 hrs dark/12 hrs light.
- Water/feed: ad libitum; GLP 4RF21 top certificate pelleted diet, water filtered from the municipal water system.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % Methocel water solution (w/v)
Details on oral exposure:
ADMINISTRATION
- Volume: 10 ml/kg

VEHICLE
- Amount of vehicle: 80 %
- Lot/batch no.: 348492/1
Doses:
2000 mg/Kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation after 30 minute, 2, 4, 6 hours at the day 1; then twice a day. The animals were weighed twice before treatment and on days 3, 8 and 14.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred in both males and females.
Clinical signs:
No clinical changes were observed in the animals.
Body weight:
Body weights of both males and females were not affected by the test article administration.
Gross pathology:
At the autopsy carried out at the end of the observation period, no appreciable macroscopic findings were evident in any treated rat.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
No death or clinical changes occurred in the animals. At the autopsy no appreciable macroscopic findings were evident in any animal. LD50 of the test item when administered to rats as a single dose by oral route is greater than 2000mg/Kg. At this dose the compound did not induce appreciable toxic signs ion the rat.
Executive summary:

Test item was administered by gavage to Sprague Dawley Crl:CD(SD) BR rats at the limit dose of 2000 mg/Kg (5 males and 5 females). All rats were treated after a 16 hours fasting period and they were weighed twice before treatment and on days 3, 8 and 14.

Rats were observed for 14 day post-treatment period in order to evaluate the substance acute oral toxicity. At day 15 the rats were killed and autopsied.

No deaths or clinical changes were recorded and autopsy did not reveal any appreciable macroscopic finding.

Conclusion

LD50 > 2000 mg/kg bw