Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Nov - 01 Dec 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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:
1996
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:
other: CD (Crl : CD (SD) IGS BR)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 258-270 g (males), 234-247 g (females)
- Fasting period before study: Animals were fasted overnight prior to administration and for approx. 3-4 h after dosing.
- Housing: 3 animals of the same sex per cage in solid-floor polypropylene cages, bedding woodflakes
- 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 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): approx. 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: 1.94 mL/kg bw
Doses:
2000 mg/kg bw
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: Animals were observed 30 min and 1, 2 and 4 hours after administration and subsequently once daily for 14 days. Individual body weights were determined prior to dosing and 7 and 14 days after administration.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off of 2500 mg/kg bw according to OECD 423
Mortality:
One female animal was found dead during the day of dosing.
Clinical signs:
Common signs of toxicity noted were ataxia, hunched posture, lethargy, piloerection, prostration, decreased respiratory rate and laboured respiration with incidents of ptosis, loss of righting reflex and splayed gait. One female animal and all male animals were comatose during the day of dosing. Surviving animals recovered two or three days after dosing.
Body weight:
The surviving animals showed expected gains in body weight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

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 > 2000 mg/kg bw was found.
Executive summary:

A group of three fasted females was treated with 2000 mg/kg bw test item. This was followed by treatment of a group of three fasted animals of the other sex at the same dose level. Only one animal (female) was found dead during the observation period, on the day of dosing. Common signs of toxicity noted were ataxia, hunched posture, lethargy, pilo-erection, prostration, decreased respiratory rate and laboured respiration with incidents of ptosis, loss of righting reflex and splayed gait. One female animal and all male animals were comatose during the day of dosing. Surviving animals recovered two or three days after dosing. The surviving animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy of animals that were killed at the end of the study. The acute oral median lethal dose, (LD50) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2500 mg/kg bodyweight.