O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate

Acute Toxicity: dermal

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

Test material information

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-2-(2-methylnonyl)phenyl O-4-(2-methylnonyl)phenyl O-2-(2-methyloctyl)phenyl 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:

other: Unspecific signs of poisoning: piloerection, abnormal body positions and dyspnea. The animals recovered within 6 days in all animals.

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.