Registration Dossier
Registration Dossier
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EC number: 257-104-6 | CAS number: 51277-96-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- only 10 instead of 20 animals were used
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid Buehler test conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- (hexadecylamidopropyl)trimethylammonium chloride
- EC Number:
- 257-104-6
- EC Name:
- (hexadecylamidopropyl)trimethylammonium chloride
- Cas Number:
- 51277-96-4
- Molecular formula:
- C22H47N2O.Cl
- IUPAC Name:
- (3-hexadecanamidopropyl)trimethylazanium chloride
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Males (357-406 g); Females (381-452 g)
- Housing: 1-4 per cage (males separate from females) in suspended stainless steel cages with wire bottom
- Diet (e.g. ad libitum): Guinea Pig Diet #5025, PMI Feeds Inc., ad libitum
- Water (e.g. ad libitum): municipal tap water, ad libitum- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 72°F±5
- Humidity (%): 30-80
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- once weekly (on days 1, 8, 15); 6 h/d
- Adequacy of induction:
- other: non-irritant substance; pre-treatment not required for Buehler test
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- on day 29; 6 h exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- pretest: 4 (2 m / 2 f)main study: 10 (5 m/ 5 f)
- Details on study design:
- RANGE FINDING TESTS:
2 f and 2 m guinea pigs were selected for irritation screening to determine both the maximum dose producing no more than moderate irritation and the maximum nonirritating dose.
Tested concentrations: 100% (400 mg of test substance moistened with 300 µL deionized water), 75%, 50% and 25 % w/v concentrations of the test substance in deionised water.
MAIN STUDYA. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance
- Control group: no treatment
- Site: lateral (left) from midline on the back
- Frequency of applications: once weekly (on days 1, 8, 15)
- Concentrations: 100%, moistened with deionised water
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 29
- Exposure period: 6 h
- Test groups: test substance
- Control group: test substance
- Site: virgin test site, laterally on the right rear quadrant of the exposure area
- Concentrations: 100%, moistened with deionised water
- Evaluation (hr after challenge): 24, 48 - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene
Results and discussion
- Positive control results:
- positive reaction in 10/10 animals after 24 h and in 4/10 animals after 48 h
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% w/v solution in acetone
- No. with + reactions:
- 10
- Total no. in group:
- 10
Any other information on results incl. tables
No skin irritation was observed after 24 or 48 h in the irritation screening test at any concentration level. Body weight gain in the treated group was comparable to the negative control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- C16 Alkylamidopropyltrimethylammonium Chloride was not sensitising in this dermal sensitisisation study in guinea pig using the Buehler method.
- Executive summary:
In a dermal sensitisation study comparable to OECD guideline 406 (17 July 1992) with C16 Alkylamidopropyltrimethylammonium Chloride (97.8% a.i.) 10 young adult Hartley guinea pigs were tested using the method of Buehler.
Test concentrations were selected based on the results of an irritation screening study: neither of the concentrations used in the pretest (100%, 75%, 50% and 25% w/v concentrations of the test substance in deionised water) produced skin irritation. Thus, in the main study 400 mg of the test substance moistened with 300 µL deionized water were used for epicutaneous induction and challenge.
After challenge no visible changes of the treated skin sites were observed in the test and control group animals 24 and 48 h after patch removal (= grade 0).
The positive control 1-Chloro-2,4-dinitrobenzene produced a sensitisation rate of 100%.
The test material produced a response in 0% of animals. According to CLP, EU GHS (Regulation (EC) No 1272/2008), a response of at least 15% of the test animals of an non-adjuvant type guinea pig test method for skin sensitisation is considered as positive.
C16 Alkylamidopropyltrimethylammonium Chloride is not a dermal sensitiser in this study.
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