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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Nov 1998 - 29 Jan 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2015
Deviations:
yes
Remarks:
no rationale for in vivo testing
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992 - 1993
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecanoic acid, ester with 1,2-propanediol
EC Number:
253-462-2
EC Name:
Dodecanoic acid, ester with 1,2-propanediol
Cas Number:
37321-62-3
Molecular formula:
C15H30O3 C27H52O4
IUPAC Name:
Dodecanoic acid, ester with 1,2-propanediol

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
NZW I.N.R.A. A9077 (known bacteriological and viral status)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: E.S.D. (Romans, 01400 Chatillon-sur-Chalaronne, France)
- Age at study initiation: about 3 months old
- Weight at study initiation: 2.3 - 2.54 kg
- Gender: male
- Housing: individually in stainless steel cages (50x60x40 cm)
- Diet (e.g. ad libitum): Pelleted complete rabbit diet, about 150 g/animal/day
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 (+/-3)
- Humidity (%): 23.4 to >45
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24 Nov 1998 - 01 Dec 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
at least the day before application back and flanks of rabbits were carefully clipped. Only animals with intact skin were included.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per animal
- Concentration (if solution): pure, considered 100% for this study

NEGATIVE CONTROL: none

POSITIVE CONTROL: none
Duration of treatment / exposure:
4 hours
Observation period:
7 days, up to full recovery
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: Codex hydrophilic eight layer gauze pad (approx 2.5 cm x 2.5 cm) maintained in contact with the skin with a perforated tape. The tape was applied on a crimped gaze bandage to fully cover the clipped area, wrapped around the animal.

REMOVAL OF TEST SUBSTANCE
Excess test article was wiped away with a gauze pad moistened with water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Morbidity: twice daily
Body weighing: on the day of dosing
Time of cutaneus readings: 1, 24, 48, 72 h, and 7days after removal of bandage.

SCORING SYSTEM:
- Method of calculation: Erythema (max. 4) and Edema (max. 4) scores as published in OECD guideline 404 (1992).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #4
Remarks:
mean over
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean over
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: #3, #6
Remarks:
mean over
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
mean over
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean over
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: #2, #3, #4, #5, #6
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility not applicable
Other effects:
No mortality during the study.

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.