2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters

EC Number:

292-124-9

EC Name:

2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters

Cas Number:

90552-04-8

Molecular formula:

C(17-19)H(32-36)O2

IUPAC Name:

2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 0023067499

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, German
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight9
- Fasting period before study: at least 16 hours before administration, but water was available ad libitum
- Housing: single housing (Makrolon cage, type III)
- Diet (e.g. ad libitum): ad libitum (LASQCdiet® Rod16, HiHyg, LASvendi (Altromin, 32791 Lage, Germany))
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 -70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 5000 mg/kg bw. was chosen in the first step with 1 female animal. Because no mortality occurred, two further animals were administered with a dose of 5000 mg/kg bw in the second step (to complete the number of three animals). In this step, no mortality occurred and the study was terminated

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, pathology, histopathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No motality occurred.

Clinical signs:

other: No clinical signs were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose of 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters after oral administration was assessed to be greater than 5000 mg/kg bw in rats.