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Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27th November 1984 to 23rd January 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecyltrimethylammonium chloride
EC Number:
203-927-0
EC Name:
Dodecyltrimethylammonium chloride
Cas Number:
112-00-5
Molecular formula:
C15H34N.Cl
IUPAC Name:
N,N,N-trimethyldodecan-1-aminium chloride
impurity 1
Chemical structure
Reference substance name:
Trimethyl(tetradecyl)ammonium chloride
EC Number:
224-958-6
EC Name:
Trimethyl(tetradecyl)ammonium chloride
Cas Number:
4574-04-3
Molecular formula:
C17H38N.Cl
IUPAC Name:
N,N,N-trimethyltetradecan-1-aminium chloride
impurity 2
Chemical structure
Reference substance name:
Cetrimonium chloride
EC Number:
203-928-6
EC Name:
Cetrimonium chloride
Cas Number:
112-02-7
Molecular formula:
C19H42N.Cl
IUPAC Name:
N,N,N-trimethylhexadecan-1-aminium chloride
Test material form:
liquid
Specific details on test material used for the study:
CAS number: 112-00-5
Mol. Weight: 263.9

Test animals

Species:
rabbit
Strain:
Vienna White
Remarks:
Gaukler: D-6050 Offenbach/main. FRG
Details on test animals or test system and environmental conditions:
Animal species: Rabbit/white VIENNA
Animal Breeder: Gaukler; D-6050 Offenbach/main. FRG
Type of cage: cage made of stainless steel with wire mesh walk floors. floor area: 40 cm x 51 cm
N° of animals per cage: 1
Animal identification: Ear tattoo (=animal N°)
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees Celsius for temperature and of 30 - 70% for relative humidity. There were no deviations from these ranges which influenced the results of the study.
Day/night rhythm: 12H/12H (6.00 - 18.00 hours/18.00 - 6.00 hours)
Bedding: No bedding in the cages: sawdust in the waste trays
Diet: KLIBA 341, 4MM. Firma Klingentalmuehle AG, Switzerland.
Drinking water: About 250mL tap water per animal per day
Acclimatization period: At least 8 days before the beginning of the study: same housing conditions as during the study
Clipping of the fur: At least 15 hours before the beginning of the study

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
Wetting of the test patch (2.5cm x 2.5cm) with the undiluted substance, and thus about 0.5mL of the test liquid is absorbed.
Duration of treatment / exposure:
Exposure périod: 4 hours
Observation period:
Observation period: 15 days
Readings: 30 - 60 minutes after removal of the test patches and 24 hours, 48 hours, 72 hours, 8 days, 15 days after the beginning of application.
Number of animals:
3 (males)
Details on study design:
Exposure period: 4H
Number of animals: 3 males / 0 female
Mean weight: 3.10 kg
Application area: 2.5 cm x 2.5 cm
Form of application: unchanged
Application volume: Wetting of the test patch (2.5cm x 2.5cm) with the undiluted substance, and thus about 0.5mL of the test liquid is absorbed.
Application site: Upper third of the back or flanks
Removal of the tes substance: At the end of the exposure period with lutrol and lutrol/water (1:1)
Observation period: 15 D
Readings: 30 - 60 minutes after removal of the test patches and 24 hours, 48 hours, 72 hours, 8 days, 15 days after the beginning of application.
Negative control: untreated skin sites of the same animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 8 days
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 8 d
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 8 d
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 15 d
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 15 d
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 15 d
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 8 d
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 8 d
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 8 d
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 15 d
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 15 d
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 15 d
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
ME animal#1 erythema: 3.3 edema: 2.7
MEanimal#2 erythema: 2.3 edema: 0.3
ME animal#3 erythema: 3.3 edema: 2.7

ME erythema: 3.0 edema: 1.9

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Very irritating / causes haemorrhage 24 hours after application of the patch (30 to 60 minutes of application).

Skin irritating Category 2 (GHS classification).
Executive summary:

Title: Report on the acute dermal irritation/corrosivity to the intact dorsal skin of the white rabbit based on OECD (404).

Testing facility: BASF aktiengesellschaft

Aim of the study: Assessment of a possible irritating or corrosive potential to the skin.

Test substance: CAS N°112 -00 -5 / 84/401

Conclusion: Very irritating / causes haemorrhage 24 hours after application of the patch (30 to 60 minutes of application). Skin irritating Category 2 (GHS classification).