Alcohols, C14-18 and C16-18-unsatd.

Endpoint summary

Description of key information

Assess the acute oral toxicity of the test substance to the rat.

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

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD and EC guidelines and in compliance with GLP

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Healthy nulliparous and non-pregnant female RccHan®:WIST albino rats were obtained from a reputable supplier.
The animals were allocated without conscious bias to cages within the treatment groups. They were housed in groups of up to three rats of the same sex.
Each animal was identified uniquely within the study by tail marking. Each cage label was colour-coded and was identified uniquely with the study number, dose level and animal mark.
The animals were allowed to acclimatise 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 160 to 177 g and they were approximately eight to nine weeks of age prior to dosing (Day 1).
Animals were housed inside a barriered rodent facility which is designed and operates to minimiseentery of external biological and chemical agents.
Own supply of filtered fresh air, maintains positive pressure withi respects to outside - passed to atmosphere and not re-circulated.
Temperature control range set to; 19 - 23C
Relative humidity control range set to; 40 - 70%
Artificial lighting to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
Stand-by electricity supply available should public supply fail.
Alarms activated is there is a failure in any of the condition parameters.
Cages - solid bottomed polycarbonated with stainless steel mesh lid. Autoclaved softwood bark-free fibre bedding in each cage.
Diet - Free access to standard rodent diet, except for overnight prior to and approximately four hours after dosing. contains no added antibiotic, chemotherapeutic or prophylactic agents. Analysed routinely by the supplier for various nutritional components and chemical and microbiological contaminants.
Water - Portable water taken from public supply, freely available via polycarbonated bottles fitted with sipper tubes. Water qualty governed by regulations published by the Department for Environment, Food and Rural Affairs - certificates received routinely from water supplier.
Cages, food hoppers, water bottles and bedding were changed at appropriate intervals.
Environmental enrichment - Aspen chew blocks provided to each cage of animals- provided throughout the study and replaced when necessary, certificate of analysis provided routinely by the supplier. Plastic shelter also provided to each cage of animals - replaced same time as cage.
No other specific contaminants that were likely to have been present in the diet or water were analysed, 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:

Two groups of three fasted female rats received a single oral gavage dose of the test substance, formulated in corn oil, at a dose level of 300 mg/kg body weight. As results at this dose level indicated the acute (median) lethal oral dose of the test substance to be greater than 300 mg/kg body weight, in compliance with the study guidelines a further two groups of three fasted females were similarly dosed at 2000 mg/kg body weight to complete the study.
During the study, clinical condition, body weight and macropathology investigations were undertaken.

Doses:

300 mg/kg body weight
2000 mg/kg body weight

No. of animals per sex per dose:

3 fasted rats per dose level.

Control animals:

no

Details on study design:

The appropriate dose volume of the test substance was administered to each rat by oral gavage using a plastic syringe and plastic catheter.
A record of the weight of each formulation dispensed and the amount remaining after dosing was made on Days one and two but was overlooked on Day 3. The balance of these two weights was compared with the predicted usage as a check that the doses had been administered correctly.
Formulations were stirred before and throughout the dosing procedure.

Sex:

female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not measured/tested

Mortality:

One female (Animal number 10) dosed at 2000 mg/kg died on Day 4. Clinical signs prior to death comprised elevated gait, decreased activity, laboured breathing, dry rales, rapid breathing, piloerection, partially closed eye lids (both eyes), red rimmed eyes (both eyes), lacrimation (both eyes) and hunched posture. These signs were seen from approximately two hour after dosing however the majority of signs were seen from Day 2. A body weight loss of 17g was noted for the decedent between Days 1 and 4. Macroscopic examination of the animal revealed congestion (characterised by darkened tissues/organs) of the kidneys, liver, lungs, spleen and subcutaneous tissue, yellow fluid content in the duodenum, large and small intestine and fluid content in the stomach, atrophy of the cecum and pallor of the heart.

Clinical signs:

other: Piloerection was seen in 2 females dosed at 2000 mg/kg (Animal numbers 0011 and 0012) upon return to the cage just after dosing and 2 females (Animal numbers 0008 and 0009) at approximately 30 minutes after dosing. Piloerection was also seen in 2 females

Gross pathology:

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

Conclusions:

The acute median lethal oral dose (LD50) to rats of UNJECOL 85AN was demonstrated to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The above result is based on a limit test and not an actual value

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The acute toxicity results for the test substance was reviewed with reference to the EU interpretation of CLP, EU Regulation 1272/2008. On the basis that the available tests confirmed the oral LD50 value to be greater than 2000 mg/kg, the test substance is therefore not classified.