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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Source: SNEA(P), CAT/Lacq
Batch 917187
Sulfur content 45.2%.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69120 L'Arbresle, France
- Age at study initiation: 6-week old
- Weight at study initiation: 182 +/- 15g for the males and 138 +/- 4 g for the females
- Fasting period before study: 18 hours
- Housing: in groups of 5 per sex in polycarbonate cages
- Diet (e.g. ad libitum): Rats - Mice sustenance ref A04 (UAR, France)
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females). The test substance was administered in its original form at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity (SG) of the test substance was 1.007.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of the test substance. A necropsy was performed on each animal sacrificed at the end of the study.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
No deaths occurred at the dose level of 2000 mg/kg.
Clinical signs:
A slight to well-defined decrease in spontaneous activity and respiratory difficulties were observed in all animals within the hours following the treatment. From day 2 to day 15, the general behaviour was normal.
Body weight:
The body weight gain of the animals was not influenced by the treatment.
Gross pathology:
The macroscopic examination revealed no abnormalities in the animal sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD0 of TPS 44 administered by oral route in rats was 2000 mg/kg.
Executive summary:

The potential acute toxicity of TPS 44 was evaluated in rats according to the recommendations of the O.E.C.D. Guideline No. 401 (O.E.C.D., 24th February 1987) for the testing of chemicals administered by oral route and the Principles of Good Laboratory Practice (O.E.C.D., 12th May 1981). TPS 44 was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females). TPS 44 was administered in its original form at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity (SG) of TPS 44 was 1.007. The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of TPS 44. A necropsy was performed on each animal sacrificed at the end of the study.

A slight to well-defined decrease in spontaneous activity and respiratory difficulties were observed in all animals within the hours following the treatment. From day 2 to day 15, the general behaviour returned was normal. No deaths occurred at the dose level of 2000 mg/kg. The body weight gain of the animals was not influenced by the treatment. The macroscopic examination revealed no abnormalities in the animal sacrificed at the end of the study.

Under these experimental conditions, the LD0 of TPS 44 administered by oral route in rats was 2000 mg/kg bw.