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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct - Nov 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

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)
Remarks:
(from the competent authority) Landesamt für Umwelt, Messungen und Naturschutz Baden-Württemberg
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
Behenylacrylate (Acrylate 22 45%)
IUPAC Name:
Behenylacrylate (Acrylate 22 45%)
Constituent 2
Reference substance name:
2-Propenoic acid, C18-26-alkyl esters
EC Number:
285-348-3
EC Name:
2-Propenoic acid, C18-26-alkyl esters
Cas Number:
85085-17-2
Test material form:
other: solid, turbid
Details on test material:
- Name of test material (as cited in study report): Behenylacrylate (Acrylate 22 45%) (Cas: 4813-57-4; 48076-38-6; 18299-85-9)
- Physical state: Solid /colorless, turbid
- Analytical purity: 93.7 %
- Lot/batch No.: 300011314299
- CAS No.: 4813-57-4, 48076-38-6, 18299-85-9

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: Young adult animals (female approx. 9 - 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: ad libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
- Justification for choice of vehicle: Solution in olive oil Ph.Eur., good solubility in standard vehicle

DOSAGE PREPARATION: The test item preparation was produced for each application group shortly before application by stirring with a magnetic stirrer. For better handling the preparation was heated at 45 °C. The preparation was administrated hand warm
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 female animals in two test groups
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were observed in the first administration group during clinical examination.
In the second test group only one animal showed impaired general state, dyspnoea and piloerection from hour 1 until hour 3 after administration.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the medin lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg bw in rats.
Executive summary:

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the test item (preparation in olive oil Ph. Eur.) were administered to two test groups of three fasted Wistar rats by gavage.

The following test substance-related clinical observations were recorded:

- 2000 mg/kg bw (first test group)

No mortality occured and no clinical signs were observed.

- 2000 mg/kg bw (second test group)

No mortality occured.

Impaired general state (one animal only), dyspnoea (one animal only), piloerection (one animal only).

The mean body weight increase within the normal range throughout the study period.

There were no macroscopic pathological findings at the end of the observation period.

The acute oral LD50 was therefore calculated to be > 2000 mg/kg bw.