Phosphorous acid, tri-C12-14-alkyl esters

Endpoint summary

Description of key information

A study performed according to OECD 423, tested Phosphorous acid, tri-C12-14-alkyl esters with 6 female SD albino rats. The test item was administered pure by gavage at 2000 mg/kg bw and no mortality was observed, no effects on behaviour and body weights and no effects was seen at macroscopically examinations of necropsy.

Phosphorous acid, tri-C12-14-alkyl esters oral LD50 cutt off was > 5000 mg/kg bw

This value was supported by the LD 50 determined > 5000 mg/kg bw in a 401 study with the triisodecyl phosphite used for read across.

Two other studies were performed with inhalation and dermal routes:

- on rats (nose only) with aerosol (mass median diameter calculated to be 0.48 µm) form during 1 hour, LC50 inhalation  > 12600 mg/m3 (maximum dose tested)

- a test was performed with rabbits, without vehicle and during 1 hour application. LD50 dermal  > 5000mg/kg bw

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:

November 2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following the guideline without any deviation but not performed under GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

not specified

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: élevage JANVIER, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 188 to 206 g
- Fasting period before study: the day before the treatment
- Housing: 3 animals per polycarbonate cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15 volume per hour
- Photoperiod: 12 hrs dark/ 12 hrs light

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: dose applied: 2000 mg/kg bw, corresponding to 2,32 mL/ kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females for the first administration and then 3 other females for confirmation

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for clinical signs and weighing at days 0, 2, 7 and 14
- Necropsy of survivors performed: yes

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study

Clinical signs:

other: no clinical signs detected

Gross pathology:

only white thickening of the stomach mucosa was found in 3 female / 6

Other findings:

no other findings

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, a oral LD50 cutt off > 5000 mg/kg bw was considered for Phosphorous acid, tri-C12-14-alkyl esters.

Executive summary:

Phosphorous acid, tri-C12-14-alkyl esters was tested in a acute toxicity class method, according to OECD 423 test guideline and without any deviation. The study was considered as reliable but was not performed under GLP conditions and a reliability 2 was then associated.

Six female Sprague Dawley rats were given 2000 mg/kg bw test substance by gavage and no clinical sign nor behaviour comportment were found. No mortality occured even after 14 day observation period.

Phosphorous acid, tri-C12-14-alkyl esters was then considered as not harmful if swallowed and could be not classified for this endpoint, according to the GHS classification criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

quoted Klimlisch 1 in the frame of US HPV dossier in 2001, then quoted 2 for read across approach

Justification for type of information:

see Read-across justification attached.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Species:

rat

Strain:

Sherman

Sex:

male/female

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 12.6 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Remarks on result:

other: maximum attainable concentration

Mortality:

No animals died during the experiment.

Clinical signs:

other:

Gross pathology:

gross pathological examination revealed no remarkable findings

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the LC 50 was determined > 12.6 mg/L air.
No death occured during the study and no clinical signs were observed.

Executive summary:

The study method was comparable to OECD 403 guideline. This study was quoted as reliability 1, reliable without restriction by the Phosphite Producers HPV Consortium and Phosphite Manufacturers Consortium in the US HPV dossier submitted in 2001 and EPA accepted their assessment.

Sherman Wistar rats were given Triisodecyl phosphite at the maximum attainable concentration of 12 mg/L by inhalation exposure, during 1 hour, whole body.

No death occured during the study and no clinical signs were observed. The LC 50 was determined > 12.6 mg/L air.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

quoted Klimlisch 1 in the frame of US HPV dossier in 2001, then quoted 2 for read across approach

Justification for type of information:

see Read-across justification attached.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure) (migrated information)

Species:

rat

Strain:

New Zealand White

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the experiment.

Clinical signs:

other: There were no signs of toxicity, except for substantial skin irritation lasting over several days.

Gross pathology:

Gross pathological examination revealed no remarkable findings.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was determined > 5000 mg/kg bw in the conditions of this limit test.

Executive summary:

The study method was comparable to OECD 402 guideline (except the use of 3 animals/ sex rather than 5 recommended by the guideline).

This study was quoted as reliability 1, reliable without restriction by the Phosphite Producers HPV Consortium and Phosphite Manufacturers Consortium in the US HPV dossier submitted in 2001 and EPA accepted their assessment.

Triisodecyl phosphite at the concentration of 5000 mg/kg bw was applied to the back of Albino rabbits, during 24 hours and observed for a 21- day period for signs of toxicity or mortality.

No death occured during the study and there were no signs of toxicity, except for substantial skin irritation lasting over several days. Gross pathological examination revealed no remarkable findings.

The LD 50 was determined > 5000 mg/kg bw in the conditions of this limit test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Justification for classification or non-classification

Using data on Phosphorous acid, tri-C12-14-alkyl esters or read across with the analogue triisodecyl phosphite, and because the tested aerosol diameter was < 1µm (then the worst case is consider), Phosphorous acid, tri-C12-14-alkyl esters is considered to be not harmful neither by oral, inhalation nor by dermal route.