Phosphoric acid, mono- and di-isotridecyl esters, compd. with 2,2'-iminobis[ethanol]

Endpoint summary

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:

From August 04, 2016 to August 31, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

Batch no.: RE 10-7
Purity/composition: 92.75%
Appearance: lightly yellow paste

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Charles River Deutschland, Sulzfeld, Germany
Age: approx. 8 weeks old
Acclimatization period: at least 5 days before start of treatment
Temperature and relative humidity: 18 to 24°C and 40 to 70%, respectively.
Light period cycle: 12-hour light/12-hour dark
Diet and water: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) and tap water, ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Method: oral gavage (plastic feeding tubes)
- Fasting: animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Administration. Frequency: single dosage on Day 1. Dose level (volume): 2000 mg/kg (2.06 mL/kg) bw. Dose volume calculated as dose level (g/kg) / specific gravity * (100 / purity (%)).

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

The test substance was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). (The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups).

Statistics:

No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Piloerection was noted for three animals on Day 1 only.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 (rats) was established to exceed 2000 mg/kg bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the acute oral LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the substance according to OECD Guideline 423 and EPA OPPTS 870.1100, in compliance with GLP. The test substance was administered by gavage to two groups of three female Wistar rats each at a dose of 2000 mg/kg bw. Animals were subjected to daily clinical observation and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred in the study. The mean body weight gain over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw (van Huygevoort, 2016).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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)

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study was conducted to determine the acute oral toxicity of the substance according to OECD Guideline 423 and EPA OPPTS 870.1100, in compliance with GLP. The test substance was administered by gavage to two groups of three female Wistar rats each at a dose of 2000 mg/kg bw. Animals were subjected to daily clinical observation and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred in the study. The mean body weight gain over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw (van Huygevoort, 2016).

Justification for classification or non-classification

Based on the acute oral toxicity study conducted with the substance, no classification for acute oral toxicity is warranted according to EU CLP (EC 1272/2008) criteria.