2-Propenoic acid, 2-propylheptyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-02-18 to 2008-04-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to OECD TG No. 423 and in compliance with GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 17, 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:

2-propylheptyl acrylate

EC Number:

604-669-5

Cas Number:

149021-58-9

Molecular formula:

C13 H24 O2

IUPAC Name:

2-propylheptyl acrylate

Test material form:

other: liquid

Details on test material:

- Name of test material: 2-Propylheptylacrylat rein
- Physical state:Colourless clear liquid
- Isomers composition: Isomeric composite of 87 % 2-Propylheptylacrylat (CAS 149021-58-9), 10 % 4-methyl-2-propylhexylacrylat (CAS 940938-91-0)
- Lot/batch No.:B4112/13 - 03122007
- Expiration date of the lot/batch: 2008-12-03
- Stability under test conditions: stable
- Storage condition of test material:Ambient temperature, in the dark, avoid temperatures > 35 °C

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Crl:(WI)BR rats from Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation: Approximately 8 weeks at the time of the test substance administration.
- Fasting period before study: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
- Diet: Ssniff R/M-H maintenance diet for rats and mice (item V1534-3 ) ad libitum, supplied by Ssniff Spezialdiaeten GmbH, 59494 Soest, Germany.
- Water: Tap water from an automatic watering system, ad libitum.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: Average of 22.5 °C (continuous control and recording).
- Humidity: Average of 49.39 % (continuous control and recording).
- Air changes: 12 per hour.
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Justification for choice of no vehicle: The administration of the undiluted test substance was requested by the sponsor.

CLASS METHOD
- Rationale for the selection of the starting dose: As requested by the sponsor, a starting dose of 2000 mg of the test substance per kg body weight was chosen

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Step 1: 3 females
Step 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 0.5, 1, 2, 3, 4 and 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Body weights were determined before administration, 7 days p.a., and 14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.

Statistics:

none

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occured, no abnormal findings were observed during the study or at necropsy

Mortality:

No mortality occured.

Clinical signs:

No abnormalities were observed.

Body weight:

All animals gained weight in both weeks p.a..

Gross pathology:

After necropsy, no abnormalities were observed.

Any other information on results incl. tables

Body weights of animals before and after administration of dose:

Animal Number  Body weight before administration  7 days p.a.  14 days p.a.   21 185  220  238   22 186  237  259   23 187  213  227   24 197  241  265   25 190  230  242   26 191  233  241