2-Propenoic acid, 2-methyl-, 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:

other: GLP guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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) methacrylate

EC Number:

810-817-1

Cas Number:

1473386-29-6

Molecular formula:

C21H40O2

IUPAC Name:

heptadecyl (branched) methacrylate

Constituent 2

Reference substance name:

C17 Methacrylate

IUPAC Name:

C17 Methacrylate

Details on test material:

- Name of test material (as cited in study report): C 17 Methacrylate
- Physical state: liquid/colorless, clear
- Analytical purity: > 99.2 %
- Lot/batch No.: S732030105

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.

Clinical signs:

No systemic clinical signs were observed in male and female rats during clinical examination.
Three out of five male animals revealed very slight erythema (grade 1) from study day 1 until day 2 or 3, respectively. One out of five female animals revealed very slight erythema (grade 1) from study day 1 until day 2.

Body weight:

The mean body weight of the male animals increased within the normal range throughout the study period.
The body weight of four female animals stagnated during the first post-exposure week, but increased normally during the second week. The fifth female showed stagnation of body weight throughout the study period.

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

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