Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 October - 1 December, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
see below
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
Deviation from OECD423:
The starting dose of 200 mg/kg is not one of the fixed levels indicated by the guideline (5, 50, 300 or 2000 mg/kg bw). Furthermore the test procedure is not precisely followed. These deviations did however not influence the integrity of the experiment.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: about 8 weeks
- Weight at study initiation: males: 217.2-244.5 g, females: 170.4-180.0 g
- Fasting period before study: 4 hours
- Housing: Makrolon cage no.3
- Diet (e.g. ad libitum): ad libitum, but fasted until 3-4 hours after application
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 40-60%, but 50-85% on days 2 to 4 due to maintenance work (no effects on experimental results)
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 4 November 2003 To: 25 November 2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 % (w/w) (low dose only)
- Amount of vehicle (if gavage): 1.91 ml/kg bw
- Justification for choice of vehicle: test substance is soluble in vehicle
- Lot/batch no. (if required): 072K0113
- Purity: not indicated

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the acute oral toxicity was expected to be moderate to low. Therefore 200 mg/kg was chosen as the starting dose.
Doses:
200 mg/kg bw
2000 mg/kg bw (dose applied undiluted)
No. of animals per sex per dose:
200 mg/kg bw: 3 males
2000 mg/kg bw: 3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
weighing: before dosing, after 7 days, at end of study;
observations (200 mg/kg): day 0-4, day 7-11, day 14
observations (2000 mg/kg): day 0-3, day 6-10, day 13-14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No statistics performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs observed.
Body weight:
Body weight development was positive and within normal ranges 7 days and 14 days post application.
Gross pathology:
No pathological organ findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value is higher than 2000 mg/kg bw and therefore the test substance is graded as of low toxic concern after single oral application. The test substance does not need to be classified for acute oral toxicity according to the Dangerous Substance Directive (67/548/EEC) and according to the CLP Regulation (EC) No 1272/2008..
Executive summary:

The acute oral toxicity to rats was determined according to OECD Guideline 423. 3 males and 3 female rats were exposed to 200 and 2000 mg/kg bw of the substance. No mortality occurred, no clinical signs were observed and the body weight development was positive and within normal ranges 7 days and 14 days post application. There were no pathological organ findings. The LD50 value is higher than 2000 mg/kg bw.