(3-chloro-2-hydroxypropyl)trimethylammonium chloride

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:

other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

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

Test material

Test material information

Constituent 1

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

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)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: 0.9% physiological saline

Induction 2

Concentration / amount:

Induction 0.5 % intracutaneous
Induction 100 % occlusive epicutaneous
Challenge 30 % occlusive epicutaneous

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: 0.9% physiological saline

Challenge 2

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: 24h
- 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)

Results

Results 1

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.

Results 2

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.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

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.