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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 March 2006 - 29 March 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
adopted 17 December 2001
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Version / remarks:
of commission directive 2004/73/EC
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
Light pink tinted powder
Specific details on test material used for the study:
Light pink tinted powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK0 Ltd, Margate, Kent, UK.
- Females (if applicable) nulliparous and non-pregnant: Yes.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: within an interval of +/- 20% of first studied animal
- Fasting period before study: Overnight
- Housing: housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Certified rat and mouse diet (Code 5LF2) supplied by BCM IPS Limited, London, UK
- Water (e.g. ad libitum): Mains
- Acclimation period: At least 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Corn oil because the test material did not dissolve /suspend in distilled water.
Details on oral exposure:
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe.
Doses:
Once, the volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing - 2000 mg/kg, 200 mg/l , 10 ml/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
in the absence of data suggesting the material was toxic, 2000 mg/kg was chosen as the starting dose. A total of 5 female rats were dosed at a level of 2000 mg/kg in the study.
Clinical observations were made /12, 1, 2 and 4 hours after dosing and subsequently once daily for forteen days. Morbitidy and mortality checks were made twice daily.
Individual bodyweights were recorded prior to fasting (Day -1), prior to dosing (day 0) and seven and forteen days after treatment
At the end of the study the animals were killed by cervical dislocation. all animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: There were no deaths.
Hunched posture was noted in all animals during the study.
Animals appeared normal one, two or five days after dosing
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of UL125 in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight

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