Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8-12 weeks
- Fasting period before study: overnight
- Housing: groups up to 4 in suspended floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet access ad libitum, with the exception of the overnight period prior to dosing and 3-4 hours post-dosing
- Water (e.g. ad libitum): mains tap water access ad libitum, with the exception of the overnight period prior to dosing and 3-4 hours post-dosing
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11 June 2008 To: 1 July 2008

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not applicable, at the 2000 mg/kg dose level the test material was administered undiluted
- Amount of vehicle (if gavage): 2.12 ml/kg undiluted material for 2000 mg/kg


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females (2000 mg/kg)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations at 0.5, 1, 2, 4 hours after dosing and then daily thereafter, bodyweights measured on days 0, 7 and 14
- Necropsy of survivors performed: yes (gross)
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: clinical observations, body weight
Statistics:
None recorded

Results and discussion

Preliminary study:
There were no signs of toxicity in the one female adminstered 2000 mg/kg of the test material over the 14 day observation period. The animal showed expected gains in bodyweight. No abnormalities were noted at necropsy.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
None
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
No gross abnormalities noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The LD50 of the test material in the female rat is >2000mg/kg bw. At this dose there were no signes of toxicity in terms of survival, body weight gain, behaviour, or gross pathology.