Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 Jan -2 Feb 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tuck & Sons Ltd, Battlesbridge, Essex, UK
- Weight at study initiation: 174 - 278 g (males and females)
- Fasting period before study: 16 - 20 h overnight
- Housing: 5 rats per cage in solid polypropylene cages, on softwood sawdust
- Diet: Rat Diet (Nottingham University, School of Agriculture, Nottingham, UK), ad libitum
- Water: mains tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
Range finding study: 10 and 20 mL/kg bw (corresponding to 8700 and 17400 mg/kg bw, respectively, based on a relative density of 0.87 g/cm³)
Main study: 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³)
No. of animals per sex per dose:
Range finding study: 1
Main study: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed to record mortality and clinical signs 1/2, 1 and 4 hour(s) after dosing and then once daily for fourteen days. The body weights of all animals were recorded on Day 0 and Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
Based on the data of the dose range-finding study a dose level of 20 ml/kg bw was selected for the main test.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Remarks on result:
other: (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³)
Mortality:
No mortality occured during the observation period.
Clinical signs:
No overt signs of toxicity were observed up to the end of the observation period.
Body weight:
No effect on body weight was noted.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
In this acute oral toxicity study in rats a LD50 value of > 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³) was found.