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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 16, 1995 to April 18, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A Buehler test was already available on the structurally similar substance.

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethyloctadecylammonium chloride
EC Number:
203-929-1
EC Name:
Trimethyloctadecylammonium chloride
Cas Number:
112-03-8
Molecular formula:
C21H46NCl
IUPAC Name:
N,N,N-trimethyloctadecan-1-aminium chloride
Test material form:
solid
Specific details on test material used for the study:
- Physical state: White to yellowish flakes
- Analytical purity: 79.8%
- Lot/batch No.: E061859561, produced on 31-05-1994

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding
- Weight at study initiation: 311 - 363 g (average 339 g)
- Housing: in groups of 5 in Type 4 macrolon cages
- Diet (e.g. ad libitum): ssniff Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For the determination of a non-irritating concentration: 0.04, 0.2, 1.0, 4.0, 20.0 (in ethanol:water / 80:20) and 100.0%
Dermal induction: 4%
Challenge: 1%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For the determination of a non-irritating concentration: 0.04, 0.2, 1.0, 4.0, 20.0 (in ethanol:water / 80:20) and 100.0%
Dermal induction: 4%
Challenge: 1%
No. of animals per dose:
6 for determination of non-irritating concentration
20 for treated group
10 for controls
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Remarks on result:
no indication of skin sensitisation
Remarks:
See below for details on results
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Determination of a non-irritating concentration

Exposure of guinea pig skin to 100 or 20% test substance resulted in moderate erythema and clearly defined edema. At 4%, the animals showed light / clearly defined erythema and very light edema. There were no signs of irritation at 1, 0.2 and 0.04%.

The doses of 4 and 1% were therefore selected for the induction and challenge phases, respectively.

Dermal induction phase

During the induction phase (Days 1 - 15), animals presented light to clearly defined erythema and very light to clearely defined edema. The skin surfaces were dry and flaky. In the control group, no effects were seen on the treated skin.

Challenge phase

24 and 48 h after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups.

Clinical signs and bodyweight

During the main test, there were no signs of toxicity and bodyweight gain of the test animals was comparable to that of controls.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Remarks:
does not qualify classification
Conclusions:
Under the conditions of the Buehler test, the substance is considered to be non-sensitizing.
Executive summary:

A study was conducted to determine the sensitization potential of the test substance, C18 TMAC (active: 79.8%), according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. The experiment was performed in guinea-pig according to the Buehler test. A pre-test was conducted to determine the non-irritating concentrations to use in the main study. During the induction phase (Days 1 - 15), the test animals were exposed to 0.5 mL of the read across substance at 4% via an occlusive bandage placed on the shaved skin of the left flank. After 6 h, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 h later. On Day 29, the test and control animals were exposed to 0.5 mL of the test substance at 1% via an occlusive bandage placed on the shaved skin of the right flank. On Days 30 and 31, a macroscopic evaluation of the treated skin was made and animal bodyweights were recorded. During the induction phase (Days 1 - 15), animals presented light to clearly defined erythema and very light to clearly defined edema. The skin surfaces were dry and flaky. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 h after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups. During the main test, there were no signs of toxicity and bodyweight gain of the test animals was comparable to that of controls. Under the study conditions, the test substance was considered to be non-sensitizing to guinea pig (Bury, 1995).