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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
as set out in 84/449/EWG (1984-09-19)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Wistar Bor: WISW (SPF Cpb)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks (males), 10 weeks (females)
- Weight at study initiation: average 169 g (males & females, weight variation not exceeding ±20%
- Fasting period before study: yes, 16h prior to application
- Housing: In groups of five in Makrolon cages type III on low-dusting wood pellets
- Diet (e.g. ad libitum): "fixed-formula" standard diet Altromin® 1324 Pellets (Altromin GmbH und Co KG, Lage) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10%
- Air changes (per hr): ca. 10/h
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 / sex / dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on application day, otherwise twice a day for clinical symptoms, weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the 14-day observation period.
Clinical signs:
After single gavage of 2000 mg/kg bw no symptoms of poisoning were observed in males and females.
Body weight:
There were no effects on growth of males and females.
Gross pathology:
All animals killed after 14 days were without pathological findings.

Applicant's summary and conclusion

Interpretation of results:
other: EU-GHS criteria not met
Conclusions:
The study was conducted under GLP according to EU method B.1 on the registered substance itself; the method is to be considered scientifically reasonable. Hence, the results can be considered as sufficiently reliable to assess the acute oral toxicity in rats. The determined LD50 value is >2000 mg/kg bw, none of the animals died after gavage of 2000 mg/kg bw. The result is suitable to determine the classification of the test item. According to Regulation (EC) No. 1272/2008, the substance does not need to be classified as acute toxic cat. IV or higher.
Executive summary:

In an acute oral toxicity study under GLP according to EU method B.1, groups of fasted 8-10 weeks old Wistar Bor: WISW (SPF Cpb) rats (5/sex) were given a single oral dose of the test item in PEG at a limit dose 2000 mg/kg bw and observed for 14 days.

 

Oral LD50> 2000 mg/kg bw

None of the animals died during the test or showed any signs of toxicity

 

The substance is of low toxicity based on the LD50 and does not need to be classified as acute toxic cat. IV or higher.