Tris(2,4-ditert-butylphenyl) phosphite

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-04-28 - 1992-05-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Due to the physical-chemical properties, TK 11682 had to be applied by weight.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2,4-ditert-butylphenyl) phosphite

EC Number:

250-709-6

EC Name:

Tris(2,4-ditert-butylphenyl) phosphite

Cas Number:

31570-04-4

Molecular formula:

C42H63O3P

IUPAC Name:

tris(2,4-ditert-butylphenyl) phosphite

Details on test material:

- Physical state: solid, white
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred on the premises
- Weight at study initiation: 211 - 267 g- Fasting period before study:
- Housing: individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: ad libitum (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland)
- Water: ad libitum- Acclimation period: 5 days

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: at least 10 %
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 g (corresponding approximately to 4 mL)
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Concentration (if solution): 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Duration of exposure:

24 hours

Doses:

2000 mg/kg

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 and weighing: daily, body weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. The animals recovered within 2 days.

Gross pathology:

No deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Upon an acute dermal administration and a 14 day post-treatment observation period, the following LD50 was determined for the test substance:LD50 (male rats): > 2000 mg/kg bwLD50 (female rats): > 2000 mg/kg bwLD50 (both sexes): > 2000 mg/kg bw