Triphenyl phosphite

Endpoint summary

Description of key information

Acute oral toxicity: LD₅₀ = 1590/1630 mg/kg bw (m/f); rat, similar to OECD TG 401, non-GLP, K2

Acute inhalation toxicity: LC₅₀ > 6.7 mg/L air (m/f); 1 h exposure, rat, similar to OECD TG 403, non-GLP, K2

Acute dermal toxicity: LD₅₀ > 5000 mg/kg bw (m/f); rat, non-guidline, non-GLP, K2

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:

1980

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)

Principles of method if other than guideline:

Study performed according to Section 1500.3 Federal Hazardous Substances Act Regulations - 16 CFR - P. 114.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 and 300 g
- Fasting period before study: yes, overnight
- Housing: in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
- Diet: ad libitum
- Water: ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

males: 1000, 1260, 1410, 1580, 2000, 2510, 3160, 3980 mg/kg bw
females: 1000, 1260, 1580, 1780, 2000, 2510, 3160, 3980 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 21 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

The LD50 was calculated employing the method described in the following publication: Finney, D. J. Statistical Methods in Biological Assay, Second Edition, London Griffin Press 1971.

Sex:

male

Dose descriptor:

LD50

Effect level:

1 590 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

1 630 mg/kg bw

Based on:

test mat.

Mortality:

All male animals of dose groups 2000 mg/kg and higher died on the first day. At 1580 mg/kg, 2 males died, and at 1410 mg/kg, one male died.
All female animals of dose groups 2000 mg/kg and higher died on the first day. At 1780 mg/kg, 3 females died. At 1580 and at 1260 mg/kg one female died.

Clinical signs:

other: Males: At lower dose levels animals were slightly depressed and ruffled. At 1580 mg/kg the animals were moderately depressed, ruffled and drooling. Several aninals became severely depressed and/or seni-comatose after 3-4 hours. These effects were reversi

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the results of this acute oral toxicity study in Sherman-Wistar rats, the LD50 was set to 1590 mg/kg bw for males and 1630 mg/kg bw for females.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 590 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

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 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

standard acute method

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-210 average weights
- Housing: in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass exposure chamber
- Exposure chamber volume: 260 l
- Method of holding animals in test chamber:
- Source and rate of air: 20 liters per minute
- System of generating particulates/aerosols: six jet Collision nebulizer (BGI Incorporated, Waltham, Mass.). The air was passed through a desleant prior to being passed through the test material
- Method of particle size determination: Andersen Sampler cascade impactor. From these values the mass median diameter of the aerosol was calculated to be 0.73 microns and the concentration was calculated to be 0.10 mg/L.
- Temperature, humidity, pressure in air chamber: 70°F

Duration of exposure:

1 h

Concentrations:

6.7 mg/liter

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 21
- Frequency of weighing: day 0 and day 21
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 6.7 mg/L air (nominal)

Exp. duration:

1 h

Mortality:

No mortalities occurred.

Clinical signs:

other: No adverse effects were observed during the one hour exposure period. No untoward symptoms were observed during the three week post exposure observation period.

Body weight:

The animals gained weight during the course of the study.

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Andersen Sampler:

Concentration = 0.24 mg/liter

Particle size = 0.73µ MMD (mass median diameter)

Interpretation of results:

study cannot be used for classification

Conclusions:

Based on the results of this inhalative acute toxicity study in rat, the LC50 was found to be > 6.7 mg/L air. Since the exposure duration was only 1h, the concentrations analysed were too low to conclude on a classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

> 6.7 mg/L air

Physical form:

inhalation: aerosol

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:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method from Noakes and Sanderson, Brit. J. Ind. Med. 26, 59, 1969

GLP compliance:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks

Duration of exposure:

24 h

Doses:

5 ml/kg

No. of animals per sex per dose:

10

Control animals:

other: control animals were treated with 90% Phenol

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

1 male animal died

Clinical signs:

other: The animal that died displayed a bad general health. All other animals were free of symptoms.

Gross pathology:

nephrosis, skin degeneration

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this dermal acute toxicity study in rat, the LD50 was found to be > 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

> 5 000 mg/kg bw

Additional information

Acute oral toxicity
In an acute oral toxicity study (K2, non-GLP, similar to OECD 401; Biosearch 1980) the test substance was administered at doses of 1000, 1260, 1410, 1580, 2000, 2510, 3160, 3980 mg/kg bw (males) and 1000, 1260, 1580, 1780, 2000, 2510, 3160, 3980 mg/kg bw (females) to 5 animals/sex/dose. The observation period following administration was 21 d. Based on the results of this acute oral toxicity study in Sherman-Wistar rats, the LD₅₀ was set to 1590 mg/kg bw for males and 1630 mg/kg bw for females.

Acute inhalative toxicity
In an acute inhalative toxicity study (K2, non-GLP, similar to OECD 403; Biosearch 1980) 5 female and 5 male rats were exposed to 6.7 mg/L air test substance for 1h. The observation period following administration was 21 d. No mortality occured, thus, the LC₅₀ was > 6.7 mg/L air for 1h exposure for males and females. Extrapolating the results to an exposure duration of 4h by applying the haber's rule, the LC₅₀ is > 1,675. This concentration is too low to conclude on a classification.

 

Acute dermal toxicity
In an acute dermal toxicity study (K2, non-GLP; BASF 1970) 5 mg/kg test substance was administered on the back and flank of Srague-Dawley rats for 24h with 10 animals/sex/dose. It is not specified if the test substance was removed afterwards. The observation period following administration was 14 d. As only one male died, the LD₅₀ was found to be > 5000 mg/kg bw (m/f).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. For dermal toxicity, the LD₅₀ value did not meet the classification criteria. Following oral dosing in rats, mortality occurred with an LD₅₀ of about 1590 mg/kg bw. As a result, the substance is considered to be classified for acute toxicity Cat. 4 under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.