Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Before LLNA method implementation
Test material information:
Composition 1
Specific details on test material used for the study:
- Physical state: White to yellowish flakes
- Analytical purity: 79.8%
- Composition of test material, percentage of components: ca. 80% steartrimonium chloride
- Lot/batch No.: E061859561, produced on 31-05-1994
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 - 363g (average 339g)
- 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: 17 - 23°C
- Humidity: 40 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
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%
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
Key result
Remarks on result:
other: see '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 48h 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.

Conclusions:
Under the study conditions, the substance was considered to be non-sensitizing (Buehler test).
Executive summary:

A study was conducted to determine the sensitization potential of the test substance 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 test 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 substance was considered to be non-sensitizing to guinea pig (Bury, 1995).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A study was conducted to determine the sensitization potential of the test substance 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 test substance at 4% via an occlusive bandage placed on the shaved skin of the left flank. After 6 hours, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 hours 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 hours 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 substance was considered to be non-sensitizing to guinea pig (Buehler test)


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

As respiratory sensitizers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for the respiratory pathway. Furthermore, the substance is a solid with a low vapour pressure. Due to it physical state and physico-chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) are created under particular conditions (e.g., spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for classification or non-classification

No skin sensitisation reactions were observed in a guinea pig Buehler test, therefore, no classification is required for sensitisation according to Directive 67/548/EEC and Regulation (EC) 1272/2008.