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Toxicological information

Skin sensitisation

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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:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
65% (3-chloro-2-hydroxypropyl)trimethylammonium chloride solution in water.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
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.