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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
Study period:
11 - 31 Jul 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No information on purity of the test substance is available from the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 22 Mar 1996
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
of Commission Directive No. 96/54/EC
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
CD (Crl : CD ® (SD) IGS BR)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 252 - 256 g (males) and 219 - 227 g (females)
- Fasting period: overnight immediately before dosing and for approx. 3 -4 h after dosing
- Housing: in groups of 3 by sex in solid-floor polypropylene cages, on wood flake bedding
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- 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: 1.89 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: As recommended by the OECD test guideline, 2000 mg/kg bw was selected as the starting dose.
Doses:
2000 mg/kg bw (step 1 and 2)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2 , 1, 2 and 4 hours after dosing and subsequently once daily for up to fourteen days. Individual body weights were recorded prior to dosing and seven and 14 days after treatment or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

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:
One male animal was found dead one day after dosing.
Clinical signs:
Common signs of systemic toxicity noted were hunched posture, lethargy and pilo-erection with incidents or isolated incidents of decreased respiratory rate,
occasional body tremors, ataxia, laboured respiration, splayed gait and red/brown staining around the snout. Surviving animals recovered 2 - 7 days after dosing.
Body weight:
The surviving animals showed expected gains in body weight over the study period.
Gross pathology:
Abnormalities noted at necropsy of the animal that died during the study were haemorrhagic lungs, dark liver, pale spleen, dark kidneys, haemorrhagic gastric mucosa and epithelial sloughing of the non-glandular region of the stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to CLP Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was found.