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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 Oct - 03 Nov 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in Feb 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted in Jul 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Federal Office of Public Health, the Swiss Agency for Therapeutic Products and the Swiss Agency for the Environment, Forests and Landscape, Switzerland
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanoic acid
EC Number:
206-376-4
EC Name:
Decanoic acid
Cas Number:
334-48-5
Molecular formula:
C10H20O2
IUPAC Name:
decanoic acid

Test animals

Species:
rat
Strain:
other: HanRcc:WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: males: 8 weeks; females: 11 weeks
- Weight at study initiation: males: 264.7-273.6 g; females: 192.7-214.2 g
- Housing: individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation
- Diet: pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: community tap water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Oct 2006 To: 03 Nov 2006

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin of the back
- % coverage: 10
- Type of wrap if used: The test item was covered with a semiocclusive dressing, which was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 mL/kg bw
- Concentration (if solution): 0.25 g/mL
- Dose Formulation: The test item was prepared in the vehicle, PEG 300, to ensure good skin contact. The test item was weighed into a tared glass beaker and the vehicle added (w/v). The formulation was prepared shortly before the application using either a magnetic stirrer and a spatula alone or combined to an Ultra-Turrax as homogenizers. Consistency of dose formulation was considered suitable for dermal application.
Duration of exposure:
24 h
Doses:
2000 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: Observations for mortality and clinical signs were performed during the first 30 minutes and at approx. 1, 2, 3 and 5 h after administration on test day 1. Thereafter observations for mortality were performed twice daily and for clinical signs once daily, respectively. Body weights were determined on test day 1 (prior to administration) and on days 8 and 15. Local signs were looked at once daily during days 2-15.
- 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:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: 4/5 males and 3/5 females were found slightly or moderately sedated on day 2 of the study after patch removal. Furthermore, at this time point 3 males and 2 females showed deep respiration and 3 males and 1 female revealed hunched posture. From day 3 on n
Gross pathology:
No macroscopic findings were noted at necropsy.
Other findings:
After removal of the dressing, slight to moderate erythema was noted in all animals. The local effects developed into slight to moderate scaling in all animals and slight scabs were observed in all animals except one female. Scaling and/or scabs were reversible within day 5 and 13 in the animals (see table 1).

Any other information on results incl. tables

Table 1: local signs observed after test substance application for 24 h

Animal No. (sex)

Local effect

Test days
(Day 1 = day of application; Day 15 = end of observation period; on day 2 patch was removed)

2

3

4

5

6

7

8

9

10

11

12

13

14

15

1 (m)

erythema

2

1

- 

 -

 -

 -

 -

 -

 -

 -

- 

- 

- 

 -

scaling

- 

2

1

1

1

1

 -

- 

 -

 -

 -

- 

 -

- 

scabs

 -

 -

1

1

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

2 (m)

erythema

2

1

1

 -

- 

 -

 -

- 

 -

 -

- 

 -

- 

 -

scaling

 -

2

2

1

1

1

 -

 -

 -

 -

 -

 -

 -

 -

scabs

 -

 -

 -

1

1

1

 -

- 

 -

 -

 -

- 

 -

 -

3 (m)

erythema

2

1

1

 -

 -

 -

 -

 -

- 

 -

 -

 -

- 

 -

scaling

 -

2

2

1

- 

 -

 -

 -

 -

 -

 -

 -

 -

 -

scabs

 -

 -

 -

1

1

1

- 

 -

 -

 -

 -

 -

 -

 -

4 (m)

erythema

2

1

1

- 

 -

 -

 -

 -

 -

 -

 -

- 

 -

 -

scaling

 -

2

2

1

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

scabs

 -

- 

 -

1

1

1

 -

 -

- 

 -

 -

 -

 -

 -

5 (m)

erythema

2

1

1

1

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

scaling

 -

1

1

1

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

scabs

 -

 -

 -

1

1

 -

 -

 -

 -

 -

- 

 -

 -

- 

6 (f)

erythema

2

1

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

scaling

 -

2

1

1

1

1

 -

 -

 -

 -

- 

 -

 -

 -

scabs

 -

 -

1

1

1

1

- 

 -

- 

 -

 -

 -

 -

 -

7 (f)

erythema

2

1

1

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

scaling

1

2

2

1

- 

 -

 -

 -

 -

- 

 -

 -

 -

 -

scabs

 -

 -

 -

 -

 -

- 

- 

 -

- 

 -

 -

 -

 -

 -

8 (f)

erythema

1

1

1

 -

- 

 -

 -

 -

 -

 -

 -

 -

 -

 -

scaling

- 

 -

1

1

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

scabs

 -

 -

 -

1

1

1

1

1

1

1

1

1

- 

 -

9 (f)

erythema

1

1

1

 -

 -

 -

- 

 -

 -

 -

 -

 -

 -

 

scaling

 -

 -

1

2

1

1

 -

 -

 -

 -

 -

 -

 -

 -

scabs

 -

 -

 -

 -

 -

 -

 -

1

1

1

1

1

 -

 -

10 (f)

erythema

1

- 

1

 -

- 

- 

 -

 -

 -

 -

 -

 -

 -

 

scaling

 -

2

2

1

1

1

 -

 -

 -

 -

 -

 -

 -

- 

scabs

 -

 -

 -

 -

 -

 -

 -

1

1

 -

- 

- 

 -

- 

1: sligth; 2: moderate: -: no local finding

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified