Reaction mass of hexadecyl acrylate and octadecyl acrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-05-15 to 2012-06-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study OECD and EU guidelines were followed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 17, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(EC) No 440/2008 of 30 May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 423.

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay, Heidelberg

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, C16-18-alkyl esters

EC Number:

292-060-1

EC Name:

2-Propenoic acid, C16-18-alkyl esters

Cas Number:

90530-21-5

IUPAC Name:

2-Propenoic acid, C16-18-alkyl esters

Test material form:

other: Liquid to solid

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, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 163 - 201 g
- Housing: Single housing, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 - 70 %
- Air changes: 10
- Photoperiod: 12 h night/12 h day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw (2 administrations)

No. of animals per sex per dose:

3 females (1 Administration)
3 females (2 Administration)

Control animals:

no

Details on study design:

Observation period: 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and on the last day of observation.
Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
A check for any dead or moribund animals was made at least once each workday.
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with increasing concentrations over time.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed

Gross pathology:

There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.