Phosphoric acid, mono- and di-C16-18-alkyl esters

Endpoint summary

Description of key information

Oral route:
The oral LD50 is >2,000 mg/kg bw
Inhalation route:
The study does not need to be conducted because exposure of humans via inhalation is not likely into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Dermal route:
The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.

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:

May to August 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD under GLP conditions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Animals were nulliparous and non-pregnant
Acclimatization; at least 5 days
Animals age: 8 to 12 weeks
Body weight: No variation greater than ±20% body weight
Animal housing: Suspended solid-floor polypropylene cages, groups of 4 animals in each cage.
Free access to water and food.
Temperature: 19 to 25ºC
Humidity: 30 to 70%

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Single dose by oral gavage, volume administered to each animal according to the fasted body weight.

Doses:

1 dose at 2,000 mg/kg

No. of animals per sex per dose:

1animal at 300 mg/kg for pre-liminary test
5 animals per dose level

Control animals:

no

Details on study design:

A total of 5 animals were treated at a dose level of 2,000 mg/kg in the study.
All animals were dosed once by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dosed animals.
Clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0, Day 7 and Day 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subject to gross pathology and this consisted of an external examination and opening of the abdominal and thoracic cavities.
The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Preliminary study:

300 mg/kg on pre-liminary test
Mortality: There was no mortality
Clinical signs: No signs of systematic toxicity were noted in the observation period.
Body weight: The animal showed expected gains in body weight over the observation period.
Gross pathology: No abnormalities were noted at necropsy.

Sex:

female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: No signs of systematic toxicity were noted in the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

not classified

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat is greater than 2,000 mg/kg bw .

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

1

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

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

3