2-Propenoic acid, heptadecyl ester, branched

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

heptadecyl (branched) acrylate

EC Number:

810-816-6

Cas Number:

1473386-36-5

Molecular formula:

C20H38O2

IUPAC Name:

heptadecyl (branched) acrylate

Constituent 2

Reference substance name:

C17 Acrylate

IUPAC Name:

C17 Acrylate

Details on test material:

- Name of test material (as cited in study report): C 17 Acrylate
- Physical state: liquid/colorless, clear
- Analytical purity: 96.2 %
- Lot/batch No.: S731910108

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.