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Acute Toxicity: dermal

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Behenylacrylate (Acrylate 22 45%)
IUPAC Name:
Behenylacrylate (Acrylate 22 45%)
Constituent 2
Reference substance name:
2-Propenoic acid, C18-26-alkyl esters
EC Number:
285-348-3
EC Name:
2-Propenoic acid, C18-26-alkyl esters
Cas Number:
85085-17-2
Details on test material:
- Name of test material (as cited in study report): Behenylacrylate (Acrylate 22 45%) (Cas: 4812-57-4; 48076-38-6; 18299-85-9)
- Physical state: Solid, colorless, turbid
- Analytical purity: 93.7 %
- Lot/batch No.: 300011314299
- CAS No.: 4813-57-4, 48076-38-6, 18299-85-9

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)
- 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

Administration / exposure

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

Results and discussion

Effect levels
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.

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