Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14th to 30th September 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in a GLP compliant laboratory according to accepted regulatory guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V (Acute toxic class)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Name of test material (as cited in study report): s-900
- Physical state: DARK BROWN PASTE
- Lot/batch No.: 02869
- Storage condition of test material: room temperature In the dark, handled under
non-actinic lighting only

- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Reputable commercial supplier
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 225-231g (males) and 201-206g (females)
- Fasting period before study: overnight before dose administration and for 3-4 hours after dose administration
- Housing: solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access (Rat and Mouse Expanded Diet No.1)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25C
- Humidity (%): 30-70%
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): Not stated

IN-LIFE DATES: From: To: 14-30th September 1999

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Arachis oil BP.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test material did not dissolve in distilled water or other aqueous vehicles.
- Lot/batch no. (if required): N/a
- Purity: Not stated

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual): Not unusual

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The information available suggested a starting dose of 2000 mg/kg.
Doses:
2000 mg/kg
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 \12, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: no
- Other examinations performed: All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded.

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:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No signs of systemic toxicity were noted during the study period.


All animals showed expected gains in bodyweight over the
study period.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy of animals killed at the end of the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose, (LD50) of the test material, S-900, in the SpragueDawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
No mortalities were noted at 2000 mg/kg bodyweight.
No symbol and risk phrase are required according to EU labelling regulations.