(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:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Rapporteur for the EU risk assessment of (3-chloro-2-hydroxypropyl)trimethylammonium chloride is the National Product Control Agency for Welfare and Health, Finland. The report is the result of in-depth work performed by experts in one Member State, working with counterparts in other Member States, Industry and public interest groups. The information reported is considered reliable.

Data source

Reference

Reference Type:

other: Published secondary source

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

not specified

Type of study:

Buehler 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

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

Concentration / amount:

65% (3-chloro-2-hydroxypropyl)trimethylammonium chloride solution in water.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

65% (3-chloro-2-hydroxypropyl)trimethylammonium chloride solution in water.

No. of animals per dose:

Number of animals in test group : 10
Number of animals in control group : 10

Results and discussion

Any other information on results incl. tables

No reaction to the test substance was observed during the induction phase. Slight erythema was observed in 2/10 animals at 24 hours on challenge. Slight localised erythema was observed at 48 and 72 hours. Localised erythema was seen in one animal at 24 hours and in another at 24, 48 and 72 hours. The challenge reactions were considered inconclusive. According to EU classification criteria the challenge reactions were not sufficient to warrant classification as a skin sensitiser.

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive and not sufficient to warrant classification as a skin sensitiser

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The substance (3-chloro-2-hydroxypropyl)trimethylammonium chloride does not warrant classification as a skin sensitiser.

Executive summary:

The potential of (3-chloro-2-hydroxypropyl)trimethylammonium chloride to induce contact hypersensitivity was examined following OECD guideline 406. No reaction to the test substance was observed during the induction phase. Slight erythema was observed in 2/10 animals at 24 hours on challenge. Slight localised erythema was observed at 48 and 72 hours. Localised erythema was seen in one animal at 24 hours and in another at 24, 48 and 72 hours. The challenge reactions were considered inconclusive. According to EU classification criteria the challenge reactions were not sufficient to warrant classification as a skin sensitiser.