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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 16, 1989 - February 2, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
EC Number:
406-940-1
EC Name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
Cas Number:
126019-82-7
Molecular formula:
C30-54H47-87O3PS
IUPAC Name:
O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate
Details on test material:
- Physical state: viscous liquid, insoluble in water; pH 7
- Storage condition of test material: room temperature
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF)/albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Ltd. Animal production, 4332 Stein/Switzerland
- Age at study initiation: 7-8 wks
- Weight at study initiation: weight variations do not exceed ± 20 per cent of the mean weight (range 166 -212 g)
- Fasting period before study: yes (overnight)
- Housing: 5/cage in Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin)
- Diet: ad libitum; Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland)
- Water: ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: the test substance is insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: at start and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
No mortality occurred up until termination (day 14). Clinical signs of toxicity were non specific (piloerection, hunched posture and dyspnoea)
Mortality:
none
Clinical signs:
Unspecific signs of poisoning: piloerection, hunched posture and dyspnoea. The animals recovered within 6 days.
Body weight:
Males: day 1 (202 ± 6.9 g); day 7 (261 ± 8.6 g); day 14 (294 ± 9.9 g)
Females: day 1 (179 ± 8.8 g); day 7 (209 ± 6.1 g); day 14 (226 ± 5.3 g)
Gross pathology:
At necropsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of the test article in rats was established to exceed 2000 mg/kg body weight.
Executive summary:

In an acute oral toxicity study according to OECD guideline 401, five male and five female rats were dosed once with the test article in peanut oil by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortalities were recorded. Piloerection, hunched posture and dyspnoea were observed in all animals. The animals recovered within 6 days. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the test article in rats was established to be greater than 2000 mg/kg body weight.