Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
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

Constituent 1
Chemical structure
Reference substance name:
Tris(p-isocyanatophenyl) thiophosphate
EC Number:
223-981-9
EC Name:
Tris(p-isocyanatophenyl) thiophosphate
Cas Number:
4151-51-3
Molecular formula:
C21H12N3O6PS
IUPAC Name:
O,O,O-tris-(4-isocyanatophenyl) thiophosphate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
SPF-bred Wistar rats of the strain HdsCpd:WU
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 206-220 g (males) and 158-165 g (females)
- Fasting period before study: about 17 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 675 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: calculated from the LD50 of the trade product (27% active ingredient in ethyl acetate)
Sex:
male/female
Dose descriptor:
other: LD50 (cut off value)
Effect level:
> 2 500 mg/kg bw
Remarks on result:
other: based on: the trade product (solution of 27% tris(p-isocyanatophenyl)thiophosphate in ethyl acetate); a dose of 2000 mg/kg bw was tolerated without any findings
Mortality:
no deaths
Clinical signs:
other: none
Gross pathology:
no findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
2000 0 / 0 / 3 --- --- 
2000 0 / 0 / 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs after treatment / number of animals treated

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test item (27 % active ingredient in ethyl acetate) was evaluated in a GLP-compliant study on male and female Wistar rats according to OECD TG 423 (Krötlinger, 2002). The oral dose of 2000 mg/kg bw was tolerated without mortalities, clinical signs, effects on weight gain or gross pathological findings. According to OECD TG 423 the LD50 cut-off level of the test item was determined with > 2500 mg/kg bw. Thus, for the active ingredient the discriminating dose can be calculated with > 675 mg/kg bw (27% of 2500 mg/kg bw).