Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-08-20 to 2002-09-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid, fine scales

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: About 8 weeks
- Weight at study initiation: 6 Female about 116 g, 6 male about 132 g
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids. Sanitation of the cages once a week.
- Diet: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum (Producer: Altromin GmbH, D-32791 Lage). Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Water: Tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C
- Humidity: 67.7 %
- Air changes: 12 per hour
- Photoperiod: Artificial light from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.1 % Na-carboxymethylcellulose plus 0.1 % Tween 80
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg bw

DOSAGE PREPARATION: The test substance was ground in a mortar and suspended in 0.1 % CMC (carboxymethyl cellulose) plus 0.1 % Tween 80 in deionised water. The suspensions were prepared freshly before administration and were administered within 5 minutes after the preparation.

CLASS METHOD:
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test substance was available, a starting dose of 200 mg of the test item per kg body weight was chosen. The further proceeding was in accordance with the guideline/directive.
Doses:
male: 200 and 2000 mg/kg bw
female: 200 and 2000 mg/kg bw
No. of animals per sex per dose:
3/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
daily observation for clinical signs 0 - 0.5, 0.5 - 1, 1 -2, 2 - 4 and 4 - 6 hours after administration and at least once a day for a total of 2 weeks. Body weight measurements were done before administration and at day 7 and 14. Body weight gain was calculated for each week of the study.
- Necropsy of survivors performed: Yes. The animals were killed by 80 % CO2 + 20 % air 14 days post application and subjected to a necropsy including a gross pathological examination.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, feed consumption, haematology, clinical biochemistry.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality observed in either male or female rats in any dose.
Clinical signs:
No relevant signs of toxicity, only signs of discomfort, were observed up to 6 h post application in the high dosed group.
Body weight:
No relevant change of body weight was observed
Gross pathology:
No relevant toxic effects on organs were observed
Other findings:
Slight reduction of plasma urea concentration in the high dosed females was observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality and no toxic effects of the test item were observed during the study period. The test item is therefore not classified as "acute toxic" according to the Directive 67/548/EEC (DSD) and the Regulation (EC) No 1272/2008 (CLP).
Executive summary:

The aim of the study was to investigate acute toxic effects of the test item after a single peroral administration to Sprague-Dawley rats according to the OECD 423. Administration of 200 and 2000 mg/kg bw were performed once per gavage to 3 males and 3 females, respectively. No clinical signs of toxicity and no mortality were observed within the observation period of 14 days. The LD50 was estimated to be > 2000 mg/kg bw.