Tris(2,4-ditert-butylphenyl) phosphite

Endpoint summary

Description of key information

LD50 oral (rat, mouse, hamster): >6000 mg/kg bw (m+f)

LD50 dermal (rat): >2000 mg/kg bw (m+f)

LD50 intraperitoneal (rat): >2000 mg/kg bw (m+f)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Limited details on housing conditions. Unclear dose/volume data. Observation period of 7 days. No Body weights are given. Limited details on clinical evaluation.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 160 - 180 g- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages (Type 3)
- Diet: ad libitum (NAFAG, Gossau SG, rat food)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): appr. 50

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 and 30 %

Doses:

1000, 3170, 4640, and 6000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 000 mg/kg bw

Mortality:

none

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 6 to 7 days.

Gross pathology:

No substance related gross organ changes were seen.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test substance in rats of both sexes observed for a period of 7 days is greater than 6000 mg/kg. The compound has therefore a slight acute toxicity to the rat by this route of administration.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

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.

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

The substance was tested for acute toxicity via oral, dermal and intraperitoneal application to different species.

 

Acute oral toxicity:

All available studies on acute oral toxicity are regarded as key studies. This is based on an overall comparable method and same dose schedule. The only difference is ascribed to species used.

An LD50 of > 6000 mg/kg bw was identified via oral application for all species.

 

Acute dermal toxicity:

The test substance is moreover found to be not acute toxic via dermal application. LD50 value of > 2000 mg/kg bw was identified.

 

Other route:

The test substance was found to be not acute toxic via intraperitoneal route. LD 50 values of > 2000 mg/kg were identified.

Since no toxic effects, neither local nor systemic, occurred via dermal and oral application routes, it can be assumed that inhalative acute toxicity is of no relevance. The test substance is therefore considered not acute toxic.

In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure.

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the test substance with regard to acute toxicity.

Test substance is not classified for acute toxicity via oral or dermal route in accordance with the CLP Regulation (EC) No 1272/2008.