Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23.07.2018 - 26.10.2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate

EC Number:

252-939-2

EC Name:

Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate

Cas Number:

36265-41-5

Molecular formula:

C33H59NO4

IUPAC Name:

didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Sex: Female (non-pregnant and nulliparous)
Number of animals: 3 per step
Age at the
beginning of the study: 8–9 weeks
Body weight on the day of administration:
Step 1: 150–165 g;
Step 2: 156–182 g

The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare [8] the animals were bred for experimental purposes.

This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

corn oil

Details on oral exposure:

Corn oil (Sigma-Aldrich, lot no. MKCF8882, expiry date: 01 October 2018) was evaluated as vehicle and was considered to be adequate. This vehicle was chosen due to its non-toxic characteristics.

Doses:

Homogeneity of the test item in the vehicle was maintained by stirring the prepared suspension throughout the dose administration to guarantee stability and homogeneity.
For all animals of the first step, 2.031 g of the test item was suspended with the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For all animals of the second step, 1.984 g of the test item was suspended with the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
The dose formulations were made shortly before each dosing occasion.

No. of animals per sex per dose:

The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.

Control animals:

yes

Details on study design:

All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw.
All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Clinical signs:

other:

Any other information on results incl. tables

Under the conditions of the present study, a single oral application of the test item Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate to rats at a dose of 2000 mg/kg body weight was not associated with severe signs of toxicity or mortality.

The median lethal dose of Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate after a single oral administration to female rats, observed over a period of 14 days is: LD₅₀cut-off (rat):5000mg/ kg bw