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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 17, 1989 - January 31, 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 402 (Acute Dermal 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 (217 - 255 g)
- Housing: individually housed in Macrolon cages type 3, 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
- Acclimatization period: at least 5 days before application

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: at least 10% of body surface (back)
- % coverage: no data
- Type of wrap if used: adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
Duration of exposure:
24 h
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:
Clinical symptoms: piloerection, abnormal body positions and dyspnea (recovered within 6 days)
Mortality:
no mortalities
Clinical signs:
Unspecific signs of poisoning: piloerection, abnormal body positions and dyspnea. The animals recovered within 6 days in all animals.
Body weight:
Males: day 1 (247 ± 6.0 g); day 7 (279 ± 8.6 g); day 14 (316 ± 13.2 g)
Males: day 1 (224 ± 6.2 g); day 7 (228 ± 8.9 g); day 14 (243 ± 6.1 g)
Gross pathology:
At necropsy, no deviations from normal morphology were found.
Other findings:
no signs of local toxicity

Applicant's summary and conclusion

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

The acute dermal toxicity of the test substance was assessed in a toxicity study following OECD guideline 402 and in compliance with GLP. The test article was administered to five Tif: RAI f (SPF) rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Unspecific signs of poisoning: piloerection, abnormal body positions and dyspnea. The animals recovered within 6 days in all animals. The mean body weight gain during the observation period was within the expected range. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of the test substance in rats was established to exceed 2000 mg/kg body weight.

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