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EC number: 203-928-6 | CAS number: 112-02-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 26, 1994 to November 24, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- Before LLNA method implementation
Test material
- 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:
- hexadecyltrimethylazanium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
additive 1
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: 227 - 299 g (average 269 g)
- Housing: in groups of 5 in Type 4 macrolon cages
- Diet (e.g. ad libitum): Altromin diet for guinea pigs, Altromin GmbH, Lage/Lippe, Germany
- 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)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- For the determination of a non-irritating concentration: 0.1, 1.0, 4.0, 20.0 and 100.0% w/v
Dermal induction: 4% w/v
Challenge: 1% w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- For the determination of a non-irritating concentration: 0.1, 1.0, 4.0, 20.0 and 100.0% w/v
Dermal induction: 4% w/v
Challenge: 1% w/v
- No. of animals per dose:
- 20 for treated group
10 for controls - Details on study design:
- For details, kindly refer to the attached background material section of the IUCLID.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- ((evaluation of erythema and edema on Day 30)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- (evaluation of erythema and edema on Day 31)
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- (evaluation of erythema and edema on Day 30)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- (evaluation of erythema and edema on Day 31)
- Key result
- Reading:
- other:
- Group:
- positive 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% w/v test substance resulted in moderate erythema and very light to light edema. At 4% w/v, the animals showed light / clearly defined erythema, and in one animal very light edema. There were no signs of irritation at 1 or 0.2% w/v.
The doses of 4 and 1% w/v 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 edema. 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
- Conclusions:
- Under the study conditions, the test substance was considered to be non-sensitizing.
- Executive summary:
A study was conducted to determine the sensitising potential of test substance, C16 TMAC (30% active in water) in guinea-pigs according to OECD Guideline 406 (Buehler method) and EU Method B6, in compliance with GLP. 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% w/v 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% w/v 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 dermal induction phase (Days 1-5), animals presented light to clearly defined erythema and very light edema. 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 were comparable to that of the controls. Under the study conditions, the test substance was considered to be non-sensitising (Bury D, 1994).
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