Octadecan-1-ol, ethoxylated, phosphates

Endpoint summary

Description of key information

Acute toxicity: Oral

Under the conditions of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified).

The acute dermal and inhalation toxicity studies were waived as exposure via these routes is not expected.

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:

21 November 2019 - 25 September 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000.

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

Purity: 100% (UVCB)
Appearance/Physical state: Solid, white pastille
Storage: At ambient temperature (15 to 25C) in the dark

Species:

rat

Strain:

other: RccHan®:WIST albino

Sex:

female

Details on test animals or test system and environmental conditions:

Animal Information
Healthy nulliparous and non-pregnant female RccHan®:WIST albino rats were obtained from Envigo RMS (UK) Ltd.

The animals were allocated without conscious bias to cages within the treatment groups. They were housed in groups of up to four rats.
Each animal was identified uniquely within the study by tail marking. Each cage label was color-coded and was identified uniquely with the study number, dose level and animal mark.

The animals were allowed to acclimatize to the conditions described below for at least 5 days before treatment. For those animals selected for this study, their body weights were in the range 156 to 175 g and they were approximately eight to twelve weeks of age prior to dosing (Day 1). The body weight variation did not exceed +/- 20% of the mean body weight of any previously treated animals.

Animal Care and Husbandry
Animals were housed inside a barriered rodent facility. The facility was designed and operated to minimize the entry of external biological and chemical agents and to minimize the transference of such agents between rooms.

The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature and relative humidity controls were set to maintain the range of 20 to 24 deg.C and 40 to 70% respectively. Any minor deviations from these ranges would not have had an adverse effect on the animals and would not affect the integrity or validity of the study. Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours. Environmental parameters are archived with the departmental raw data.

Periodic checks were made on the number of air changes in the animal rooms. Temperature and humidity were monitored daily.
Alarms were activated if there was any failure of the ventilation system, or temperature limits were exceeded. A stand-by electricity supply was available to be automatically brought into operation should the public supply fail.

The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fiber bedding. Cages, food hoppers, water bottles and bedding were changed at appropriate intervals.

The animals were allowed free access to a standard rodent diet (Teklad 2014C Diet), except for overnight prior to and approximately four hours after dosing. This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.

Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.

Each cage of animals was provided with an Aspen chew block for environmental enrichment. Chew blocks were provided throughout the study and were replaced when necessary. Each cage of animals was provided with a plastic shelter for environmental enrichment, which was replaced at the same time as the cages.

Each batch of diet was analyzed routinely by the supplier for various nutritional components and chemical and microbiological contaminants. Supplier’s analytical certificates were scrutinized and approved before any batch of diet was released for use. The quality of the water supply is governed by regulations published by the Department for Environment, Food and Rural Affairs. Certificates of analysis were received routinely from the water supplier. Certificates of analysis were received routinely from the supplier of the chew blocks. Since the results of these various analyses did not provide evidence of contamination that might have prejudiced the study, they are not presented.

No other specific contaminants that were likely to have been present in the diet or water were analyzed, as none that may have interfered with or prejudiced the outcome of the study was known.

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Fasted female rats received a single oral gavage dose of the test item, formulated in corn oil, administered at a volume of 10 mL/kg body weight.

Doses:

Sighting investigations: 300 and 2000 mg/kg body weight, one animal each.

Main study: Based on the results of the sighting investigations a further four fasted females were similarly dosed at 2000 mg/kg body weight.

No. of animals per sex per dose:

1 animal per dose, followed by four animals per dose.

Control animals:

no

Details on study design:

During the study, clinical condition and, body weight and macropathology investigations were undertaken.monitored. All animals were subjected to gross necropsy and macroscopic examination at study termination on Day 15.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no unscheduled deaths.

Clinical signs:

other: There were no clinical signs of reaction to treatment.

Gross pathology:

No abnormalities were noted in any animal at the necropsy and macroscopic examination at study termination on Day 15.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified).

Executive summary:

The study was performed to assess the acute oral toxicity of the test item following a single oral dose to the female rat.

All six rats survived to the scheduled necropsy. There were no unscheduled deaths or clinical signs of reaction to treatment and all animals were considered to have achieved satisfactory body weight gains throughout the study based on historical data from the supplier for this strain.

No abnormalities were noted in any animal at the necropsy and macroscopic examination at study termination on Day 15.

The acute median lethal oral dose (LD₅₀) of the test item in the female rat was demonstrated to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

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 skin contact in production and/or use is not likely

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In an acute oral toxicity study, Octadecan-1-ol, ethoxylated, phosphates (CAS RN 62362-49-6) is included in Category 5/Unclassified, according to the Globally Harmonized System (GHS), described in Annex 2.