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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:
2012-05-15 to 2012-06-15
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17, 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
(EC) No 440/2008 of 30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
Deviations:
no
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

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
No. of animals per sex per dose:
3 females (1 Administration)
3 females (2 Administration)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, gross-pathology

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
Body weight:
The mean body weight of the surviving animals increased within the normal range throughout the study period. Except one animal of the first test group, which showed stagnation of body weight during the second post-exposure week.
Gross pathology:
There were no macroscopic pathological findings in the surviving 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 Stearylacrylate, Synative MM SA, Stearyl 1618 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 median 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 undiluted test item were administered to two test grooups of three fasted Wistar rats by gavage.

The following test substance-related clinical observations were recorded:

2000 mg/kg:

- No mortality occured.

- No clinical signs were observed.

- The mean body weight of the surviving animals incresed within the normal range throughout the study period. Except one animal of the first test group, which showed stagnation of body weight during the second post-exposure week.

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

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