2-Propenoic acid, heptadecyl ester, branched

Endpoint summary

Description of key information

LD50(rat) oral: > 2000 mg/kg bw (BASF, 2014)
LD50(rat) dermal: > 5000 mg/kg bw (BASF, 2014)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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)

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, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Other examinations performed: clinical signs, body weight, pathology

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

In both test groups no mortality occurred.

Clinical signs:

No clinical signs were observed in both test groups during clinical examination.

Body weight:

The mean body weight of the first test group increased throughout the study period within the normal range with one exception. One animal did not gain weight properly during the second week.
In the second test group the mean body weight increased within the normal range in the first week, but in the second week one animal marginally lost weight and one animal did not gain weight properly, while the third animal revealed an increase of body weight within the normal range.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	female	female
Administration:	1	1
No. of animals	3	3
Mortality (animals)	No mortality	No mortality

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of C 17 Acrylate after oral administration was found to be greater than 2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP guideline study

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight, actual weights)
- Housing: Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10
- 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 (if done): Afterwards removal of the semi-occlusive dressing, 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

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, pathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred during the observation period.

Clinical signs:

No systemic clinical signs were observed during clinical examination.
In all male animals well-defined erythema (grade 2) was observed on study day 1 and persisted in 3 males until study day 3. In two animals moderate erythema (grade 3) was noticed on study day 2 and 3 after application. On study day 6 very slight erythema (grade 1) was observed in all male animals and persisted in three of these animals until study day 7 or 8.
Slight edema (grade 2) was noted in all animals on study day 1 and persisted until study day 2 or 3 in three animals. Slight edema increased to moderate edema (grade 3) in two animals on study day 3 or in one animal from day 2 until day 3. On study day 6 very slight edema (grade 1) was observed in two male animals. From study day 6 until study day 7, 13 or 14 incrustations were noted in three animals.
Scaling was observed on study day 6 in four animals and persisted in these animals up to study day 10 or 14. In one male scaling was seen on study day 7 only.
In all female animals well-defined erythema (grade 2) was noticed on study day 1 and persisted in four animals until study day 3. Moderate erythema (grade 3) was seen in one animal on study 2 and 3. Very slight erythema (grade 1) was noted in all females on study day 6 and persisted in two of these females until study day 7 or 8.
Slight edema (grade 2) was seen in all female animals from study day 1 until study day 3, while very slight edema (grade 1) was observed on study day 6 in two animals.
Incrustations were observed in one animal from study day 2 until study 7 and from study day 13 until study day 14, while in another animal these finding was observed from study day 6 until study day 14. In a third female animal incrustations were observed from study day 8 until study 10, while a fourth female showed incrustations on study day 13 and 14.
Scaling was observed in all animals from study day 6, 7 or 8 until study day 10 or 14, respectively.

Body weight:

The mean body weight of the male animals increased within the normal range throughout the study period.
The body weight of two female animals adequately increased throughout the study period. The body weight of another female stagnated during the first week, while the body weight of fourth animal stagnated during the second week. A fifth animal showed marginally body weight loss during the first week and only a slight increase in weight 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.

Mortality
Dose (mg/kg bw):	5000	5000
Sex:	female	male
Administration:	1	1
No. of animals	5	5
Mortality (animals):	No mortality	No mortality

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of C 17 Acrylate after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

GLP guideline study

Additional information

oral

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg of the undiluted test item C 17 Acrylate were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females). No mortality occurred and no clinical signs were observed. The mean body weight of the first test group increased throughout the study period within the normal range with one exception. One animal did not gain weight properly during the second week. In the second test group the mean body weight increased within the normal range in the first week, but in the second week one animal marginally lost weight and one animal did not gain weight properly, while the third animal revealed an increase of body weight within the normal range. There were no macroscopic pathological findings at the end of the observation period. The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

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 C 17 Acrylate 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. No mortality occurred and no clinical signs were observed. The following test item-related local effects were recorded during the course of the study, local effects occurred within 14 days after administration: Very slight to moderate erythema (grade 1 to 3), very slight to moderate edema (grade 1 to 3), incrustations, scaling. The mean body weight of the male animals increased within the normal range throughout the study period. The body weight of two female animals adequately increased throughout the study period. The body weight of another female stagnated during the first week, while the body weight of fourth animal stagnated during the second week. A fifth animal showed marginally body weight loss during the first week and only a slight increase in weight during the second week. The body weight of the male 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.

Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

Based on the available studies data on acute toxicity properties the test item would not have to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP).