Reaction mass of dodecyl acrylate and tridecyl acrylate

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:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

Regulation (EC) No 1907/2006

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, C12-14-alkyl esters

EC Number:

282-516-8

EC Name:

2-Propenoic acid, C12-14-alkyl esters

Cas Number:

84238-60-8

Molecular formula:

Unspecified

IUPAC Name:

84238-60-8

Test material form:

other: liquid/clear, colorless

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, 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, actual weights)
- Housing: single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h /12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10% of the body surface


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

Duration of exposure:

24 hours

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
- Frequency of observations and weighing: Clinical oberservation: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. 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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred.

Clinical signs:

No systemic clinical signs were observed during clinical examination.
Very slight to severe erythema (grade 1 to 4). Very slight to moderate edema (grade 1 to 3). Incrustations. Severe scaling. Additionally, all local signs were noted beyond the application site.

Body weight:

The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week.

Gross pathology:

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

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 Laurylacrylate 1214 after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

Executive summary:

The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats (OECD 402).

The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.

No unscheduled deaths and no clinical signs indicative of systemic toxicity were observed in any animals.

Very slight to severe erythema (grade 1 to 4).  Very slight to moderate edema (grade 1 to 3). Incrustations. Severe scaling.  Additionally, all local signs were noted beyond the application site. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week. 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 Laurylacrylate 1214 after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.