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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from 1989-05-23 to 1989-06-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
assessment report
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
scare formation after 14 days in 2/3 animals
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
scare formation after 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
scare formation after 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days in 2/3 animals
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
0.2
Max. score:
1
Reversibility:
other: no significant irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.3
Max. score:
1
Reversibility:
other: no significant irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.3
Max. score:
1
Reversibility:
other: no significant irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was corrosive after a 4 hour exposure period.
Executive summary:

The study used as source investigated skin irritation/corrosion. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides
EC Number:
263-090-2
EC Name:
Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides
Cas Number:
61789-80-8
Molecular formula:
R2Me2N(+)Cl(-) whereas R = mainly C16, 18-alkyl molecular weight range is based on R=14 (lower limit value) and R=18 (higher limit value)
IUPAC Name:
N,N-Dimethyl-N,N-di-n-alkyl(C16-18)-ammoniumchloride
Details on test material:
- Name of test material (as cited in study report): Genamin DSAC (Dioctadecyldimethylammonium chloride)
- Physical state: paste

- Composition of test material, percentage of components: approximately 97% active, 3% water
- Isomers composition: n.a.
- Purity test date: no data
- Lot/batch No.: E01-23696GD
- Expiration date of the lot/batch: 1988
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: darkness, room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Germany
- Age at study initiation: ca. 3 - 5 month
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: individually, stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hour interval

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours, 3 minutes
Observation period:
14 days
Number of animals:
3 (4 h), 3 (3 min)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
scare formation after 14 days in 2/3 animals
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
scare formation after 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
scare formation after 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days in 2/3 animals
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
0.2
Max. score:
1
Reversibility:
other: no significant irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.3
Max. score:
1
Reversibility:
other: no significant irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.3
Max. score:
1
Reversibility:
other: no significant irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Remarks on result:
other: 3 minute exposure

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Technical grade Praepagen WK (77% dioctadecyldimethylammonium chloride, 11.3% isopropanol, 11.7% water) was corrosive after a 4 hour exposure period.
Executive summary:

In a GLP conform study, Praepagen WK (77% active in isopropanol/water) was tested for skin irritation / corrosion according to OECD test guideline 404. For this 0.5 mL of moistened Praepagen WK was applied semi-occlusively for 3 minutes or 4 hours to the shaved skin of three or one New Zealand White rabbits, respectively. The skin then was examined 30 - 60 minutes and 24, 48 and 72 hours after removal of the dressing. Since effects were still present after 72 hours, additional readings were performed after 7 and 14 days. Results for the 3 minute exposure period (3 animals): One hour and 24 hours following removal of the patches slight erythema were noted in two animals. No signs of irritation were observed after 48 hours and later. Results for the 4 hour exposure period (3 animals): One hour after removal of the patches the skin of the animals exhibited slight erythema and moderate oedema. At the 24 to 72 hour readings moderate erythema and slight to moderate oedema were observed. Additionally the skin was leathery. Seven days p.a. moderate to severe erythema in all animals and slight oedema in one animal appeared. Swelling of the other animals couls not be assessed because of induartion. This was still partially the case after 14 days. In two rabbits well-defined to severe erythema and slight oedema were observed at this time point. The skin was also indurated, raised, scabbed, chapped, parchement-like and with fine or coarse scales. A scar had developed in two animals 14 days after the apllication. Based on the results of this study, Praepagen WK (77% active in isopropanol/water) should be classified as corrosive to skin.