Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral:
The test item, 2-Propenoic acid, C16-18-alkyl esters (read across) was tested in two oral studies. The oral LD50 was greater than 2000 mg/kg bw.

Additionally, Behenylacrylate (read across) was tested in an acute oral toxicity study. The oral LD50 was also greater than 2000 mg/kg bw.
Based on these results the LD50 oral value of 2-Propenoic acid, octadecyl ester is also considered to be greater than 2000 mg/kg bw.
Dermal:
The test items, 2-Propenoic acid, C16-18-alkyl esters (read across) and Behenylacrylate (read across) were tested in an acute dermal toxicity study. The dermal LD50 was greater than 5000 mg/kg bw in both studies.
Based on these results the LD50 dermal value of 2-Propenoic acid, octadecyl ester is also considered to be greater than 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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
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
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
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
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.

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.

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.

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
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
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
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
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and guideline compliant study. Read across was performed with 2-Propenoic acid, C16-18-alkyl esters and Behenylacrylate. Please refer to IUCLID section 13 for read across justification.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-05-21 to 2012-06-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Commission Regulation (EC) No 440/2008 of 30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 402.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassy, Heidelberg
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: 243 - 249 g (male), 206 - 218 g (female)
- Housing: Single housing, Makrolon cage, type III
- Diet: 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: 22 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, organ weights, gross-pathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Mortality:
No mortality occurred
Clinical signs:
No signs of systemic toxicity were observed.
The following test item-related local effects were recorded during the course of the study:
- Very slight to moderate erythema (grade 1 to 3)
- Very slight to slight edema (grade 1 to 2)
- Incrustations
Body weight:
The mean body weight of the animals increased within the normal range throughout the study period
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Under the conditions of this study the median lethal dose (LD50) of Stearylacrylate, Synative MM SA, Stearyl 1618 after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.
Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface are. The animals were observed for 14 days.

No mortality occurred.

No signs of systemic toxicity were observed.

The following test item-related local effects were recorded during the course of the study:

- Very slight to moderate erythema (grade 1 to 3)

- Very slight to slight edema (grade 1 to 2)

- Incrustrations

The mean body weight of the animals increased within the normal range throughout the study period.

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 5000 mg/kg bw.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
(from the competent authority) Landesamt für Umwelt, Messungen und Naturschutz Baden-Württemberg
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/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 (male approx. 8 weeks, female approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: no
- 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
Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10% of the body surface
The test item was covered with an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
The test item preparation was produced 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
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
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 Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
No local effects were observed.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of almost all female animals did not adequately increase during the first post-exposure week, but the females gained weight in a normal range during the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Under the conditions of this study the median lethal dose (LD50) of the test item after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose of the test substance after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.
Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the test substance (as solution in olive oil Ph. Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.

The following test item-related effects were recorded:

- No mortality occured

- No signs of systemic toxicity or skin effects

- The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of almost all female animals did not adequately increase during the first post-exposure week, but the females gained weight in a normal range during the second week.

- No macroscopic pahologic abnormalities

Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
GLP and guideline compliant study. Read across was performed with 2-Propenoic acid, C16-18-alkyl esters and Behenylacrylate. Please refer to IUCLID section 13 for read across justification.

Additional information

Oral:

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the undiluted test item 2-Propenoic acid, C16-18-alkyl esters (read across) was administered to two test groups of three fasted Wistar rats by gavage according to OECD guideline No. 423. The following test substance-related clinical observations were recorded (2000 mg/kg): No mortality occurred. No clinical signs were observed. 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. 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 LD50, oral, rat > 2000 mg/kg bw.

In the supporting study with Stearylacrylate, the test item was tested in the acute oral toxicity study to 5 male and 5 female Wistar rats. The dose was 5000 mg/kg bw. No mortality was observed. No organs abnormalities was observed.

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of Behenylacrylate (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.

Based on these results the LD50 oral value of 2-Propenoic acid, octadecyl ester is also considered to be greater than 2000 mg/kg bw.

Inhalation:

In accordance with column 2 of Reach Regulation (EC) No 1907/2006, section 8.5.2 testing on acute inhalation toxicity can be waived if the vapour pressure of the tested substance indicates no risk of exposure. Due to the very low vapour pressure of the test item 2-Propenoic acid, octadecyl ester (0.000639 Pa at 20 °C), it is extremely unlikely that toxic concentrations could ever be reached.

Hence, the inhalation pathway is not considered a relevant route of exposure.

Dermal:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item, 2-Propenoic acid, C16-18-alkyl esters (read across) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours according to OECD guideline no. 402. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality was occurred. No signs of systemic toxicity were observed. The following test item-related local effects were recorded during the course of the study:

- Very slight to moderate erythema (grade 1 to 3)

- Very slight to slight edema (grade 1 to 2)

- Incrustations

The mean body weight of the animals increased within the normal range throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw.

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of Behenylacrylate (as solution in olive oil Ph. Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.

The following test item-related effects were recorded:

- No mortality occured

- No signs of systemic toxicity or skin effects

- The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of almost all female animals did not adequately increase during the first post-exposure week, but the females gained weight in a normal range during the second week.

- No macroscopic pahologic abnormalities

Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 5000 mg/kg bw.

Based on these results the LD50 dermal value of 2-Propenoic acid, octadecyl ester is also considered to be greater than 5000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occured at the limit dose of 2000 mg/kg bw in oral acute toxicity studies and at the limit dose of 5000 mg/kg bw in dermal acute toxicity studies. As a result, the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.