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Diss Factsheets

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:
May 7, 1991 - May 28, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Didecyldimethylammonium chloride
EC Number:
230-525-2
EC Name:
Didecyldimethylammonium chloride
Cas Number:
7173-51-5
Molecular formula:
C22H48N Cl
IUPAC Name:
didecyldimethylammonium chloride
Details on test material:
- Name of test material: DDAC (52% active)
- Physical state:Clear, colourless liquid
- Analytical purity:No data
- Composition of test material, percentage of components: 52% Didecyldimethylammonium chloride, 28% water and 10% isopropanol
- Purity test date:13.06.1991
- Lot/batch No.:E06156439
- Expiration date of the lot/batch: Atleast 2 years from the date of manufacture
- Stability under test conditions:Stable
- Storage condition of test material:Darkness at room temperature in a fume cupboard

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Hoechst AG, Kastengrund, Conventional breed
- Age at study initiation:3-5 months
- Weight at study initiation:3.2-3.8 kg
- Housing:Separate cages
- Diet (e.g. ad libitum):Altromin 2123 rabbit maintenance diet
- Water (e.g. ad libitum):Deionised, chlorinated water
- Acclimation period:No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18±3ºC
- Humidity (%):55±20%
- Air changes (per hr):No data
- Photoperiod (hrs dark / hrs light):12 hrs/12 hrs

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL
- Concentration (if solution):Neat
Duration of treatment / exposure:
3 minutes and 4 hours
Observation period:
30-60 min, 24, 48 and 72 hrs
Number of animals:
Six, three for 3-min exposure and three for 4-hr exposure
Details on study design:
TEST SITE
- Area of exposure:2.5X2.5 cm2
- Type of wrap if used:Surgical plaster covered with semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done):with warm tap water
- Time after start of exposure:4 hours

SCORING SYSTEM:Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3-min exposure group
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3 min exposure group
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3-min exposure group
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3-min exposure group
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3-min exposure group
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3-min exposure group
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3-min exposure group
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 days in the 3-min exposure group
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h in the 4 h exposure group
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h in the 4 h exposure group
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h in the 4 h exposure group
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h in the 4 h exposure group
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h in the 4 h exposure group
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h in the 4 h exposure group
Irritant / corrosive response data:
Exposure to the test substance for 4 hours resulted in well-defined to severe erythema as well as very severe edema from 30 minutes upto 72 hours after removal of patches. Additionally, the skin surfaces was largely discolored, dry, rough and scabbed.

Exposure to the test substance for 3 min resulted very slight edema and from 30 min to 72 hours after removal of the patches. Additionally very slight to severe erythema were observed upto 7 days. Additionally, the skin surfaces was largely discolored, dry, rough and leather-like.
Other effects:
None

Any other information on results incl. tables

All animals in the 4 hour exposure group were sacrificed after the 72 hour observation period.                     

Applicant's summary and conclusion

Conclusions:
Based on the study results, the test substance is considered to be corrosive to skin.
Executive summary:

A study was carried out in rabbits to determine the primary dermal irritation of the test substance according to OECD guideline and EU method, under GLP conditions. Dorsal hair is removed by clipping in 6 animals and the neat test substance was applied to the clipped skin under a semi-occlusive bandage. The animals were divided into two groups according to the exposure period - 3 -minute and 4 -hours exposure groups. After removal of the patches, the skin is observed for signs of irritation. In this study, the 4 h exposure produced severe erythema and severe edema up to the 72 h observation period and the skin appeared rough, dry, scabbed with discoloration. The 3 minute exposure produced slight erythema, slight to severe edema up to 7 days and at end of 14 day observation period, the skin appeared dry, rough and leather-like. The mean score for edema and erythema was 4 up to the observation period of 72 h. Based on the study results, the test substance was found to be corrosive to skin.