Registration Dossier
Registration Dossier
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EC number: 222-048-3 | CAS number: 3327-22-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-06-22 to 1993-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study from 1993 readily available
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- EC Number:
- 222-048-3
- EC Name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- Cas Number:
- 3327-22-8
- Molecular formula:
- C6H15ClNO.Cl
- IUPAC Name:
- 3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
- Details on test material:
- 69.32 % solution of a 98.55 % pure solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White (Bor:DHPW)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH, Borchen, GERMANY
- Age at study initiation: 9 wk
- Weight at study initiation: 466-521 g (males); 382-471 g (females)
- Housing: 1/Macrolon cage type IV
- Diet: standared diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-20.5
- Humidity (%): 50-75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1993-06-22 To: 1993-07-16
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9% physiological saline
- Concentration / amount:
- Induction 0.5 % intracutaneous
Induction 100 % occlusive epicutaneous
Challenge 30 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% physiological saline
- Concentration / amount:
- Induction 0.5 % intracutaneous
Induction 100 % occlusive epicutaneous
Challenge 30 % occlusive epicutaneous
- No. of animals per dose:
- 10 treatment; 5 vehicle control
- Details on study design:
- (NB: TS is 69% aqueous solution)
RANGE FINDING TESTS: preliminary test conducted - no details given
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal-3 paired injections; topical)
- Exposure period: topical 48h
- Test group: 10
- Control group: +ve no details on group size; -ve (vehicle) 5
- Site: two rows of 3 sites, one row either side of dorsal mid-line
- Frequency of applications: intradermal treatment day 0; topical induction day 7
- Duration: induction period continues to day 21
- Concentrations:
intradermal: 1:1 FCA saline; 0.5% TS in saline; 0.5% TS 1:1 FCA
topical: 100% TS
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test group: 10
- Control group: +ve no details on group size; -ve (vehicle) 5
- Site: flank
- Concentrations: 30% TS in saline
- Evaluation (hr after challenge): 24 and 48 h following patch removal - Challenge controls:
- vehicle control
positive control - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- 1,4-phenylenediamine X2 HCl. Last examination April 1993. (No further details given)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% TS in saline (NB: TS is 69% in aqueous solution)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% TS in saline (NB: TS is 69% in aqueous solution). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% in saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% in saline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: not specified
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- other: not specified
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- other: not specified
- Reading:
- 2nd reading
- Group:
- negative control
- Remarks on result:
- other: not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A well conducted, well reported guinea-pig skin sensitization test (Magnusson & Kligman method) found in the test substance (a 69% aqueous solution of CHPTAC) no evidence of sensitizing potential when challenged with a 30% solution of the TS in saline. Appropriate negative and positive controls were conducted.
- Executive summary:
In a dermal sensitization study (OECD 406) with CHPTAC (69% aqueous solution), young adult female guinea-pigs of the Dunkin-Hartley strain were tested using the method of Magnusson and Kligman. No dermal reactions were seen when challenging with a 30% solution of the test material in saline. In this study, CHPTAC (69%) is not a dermal sensitizer.
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