2-Propenoic acid, heptadecyl ester, branched

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:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

heptadecyl (branched) acrylate

EC Number:

810-816-6

Cas Number:

1473386-36-5

Molecular formula:

C20H38O2

IUPAC Name:

heptadecyl (branched) acrylate

Constituent 2

Reference substance name:

C17 Acrylate

IUPAC Name:

C17 Acrylate

Details on test material:

- Name of test material (as cited in study report): C17 Acrylate
- Physical state: liquid/colorless, clear
- Analytical purity: 96.2 %
- Lot/batch No.: S731910108

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, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- 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)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Other examinations performed: clinical signs, body weight, pathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

In both test groups no mortality occurred.

Clinical signs:

No clinical signs were observed in both test groups during clinical examination.

Body weight:

The mean body weight of the first test group increased throughout the study period within the normal range with one exception. One animal did not gain weight properly during the second week.
In the second test group the mean body weight increased within the normal range in the first week, but in the second week one animal marginally lost weight and one animal did not gain weight properly, while the third animal revealed an increase of body weight within the normal range.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Any other information on results incl. tables

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	female	female
Administration:	1	1
No. of animals	3	3
Mortality (animals)	No mortality	No mortality

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of C 17 Acrylate after oral administration was found to be greater than 2000 mg/kg bw in rats.