Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 October 1985 to 19 November 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no data on purity

Data source

Reference
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
no data on purity of the tested substance

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna Ltd, Wyton, Huntingdon UK
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 172-200 g; females 172-183 g
- Fasting period before study: overnight until 2 hours post dosing
- Housing: 5/sex/polypropylene cage
- Diet: Rat and Mice Expanded Diet no 1 (Special Diet Srvices Ltd, Witham, Essex UK) ad libitum):
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 40-65%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:clinical signs and mortality : after 1 and 4 hours and daily thereafter
- Body weight: on day 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Preliminary study:
Hunched posture, piloerection and diarrhea on day 1 at 2000 and 5000 mg/kg bw
No mortality
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Hunched posture, piloerection and diarrhea on day 1
Body weight:
within normal ranges
Gross pathology:
no effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the substance tested the LD50 is >5000 mg/kg bw.
Executive summary:

In an acute oral study, rats (5/sex) received the substance by oral gavage at 5000 mg/kg bw. No effects on mortality, bodyweight or macroscopy were found after the 14 day observation period. On day 1 of the test hunched posture, piloerection and diarrhea were observed. The LD50 is > 5000 mg/kg bw.