2,3-epoxypropyltrimethylammonium chloride

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: EU Risk Assessment report

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Although the EU risk assessment report is secondary literature, all data and risk assessment for the human, health and the environment have been evaluated and reviewed by Finland prior to publication. The risk assessment report has been submitted to final approval and published in the Official Journal of the European Union C157/10 dated on 21.06.2008. Thus, it is considered the information reported are reliable with the restrictions that reliability of the data presented has not been assessed again.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

European Union Risk Assessment 2,3-epoxypropyltrimethylammonium chloride CAS RN 3033-77-0 Einecs No: 221-221-0

Author:

EC

Year:

2008

Bibliographic source:

Risk Assessment. Final approved version. Rapporteur: Finland (FIN). European communities. Printed in Italy. 147pp

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Patch tests: the test substance was applied on patient's back and the application time was usually 24h. The results were read 24, 48 and 72h after the
removal.
Prick tests were performed with x standard allergens.

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropyltrimethylammonium chloride

EC Number:

221-221-0

EC Name:

2,3-epoxypropyltrimethylammonium chloride

Cas Number:

3033-77-0

Molecular formula:

C6H14NO.Cl

IUPAC Name:

N,N,N-trimethyl(oxiran-2-yl)methanaminium chloride

Method

Type of population:

occupational

Route of administration:

dermal

Results and discussion

Any other information on results incl. tables

Tables of results of the patch tests performed in patients allergic to EPTAC

Cases report (1)

Case	1	2	3	4
EPTAC 1%	++	+++	+++	No tested
EPTAC 0.5%	No tested	No tested	No tested	++
EPTAC 0.2%	++	+++	+++	++
EPTAC 0.1%	No tested	No tested	No tested	++
EPTAC 0.05%	No tested	+	No tested	No tested

Cases report (2)

Patient number 3 reacted "++" to 0.2% ECT and "+" to 0.1%. The other two had weaker "?+" and "+" reactions. Prick tests were negative, except in one case of pollen.

Cases report (3)

Test substance	1	2	3
EPTAC 1% in petrolatum	+++	++	++
EPTAC 0.5% in petrolatum	+++	++	++
EPTAC 0.1% in petrolatum	+	? +
EPTAC 0.05% in petrolatum	-	-	-

Cases report (4)

Both patients test positive with 1% dilution of EPTAC. One of the patients had a positive, although slight, response already at 0.1% of the test substance.

Applicant's summary and conclusion

Conclusions:

Based on the positive results in the patch tests in humans, it can be concluded that EPTAC is a skin sensitizer.

Executive summary:

In several cases of workers who developped skin disease caused by exposure to epoxy compounds, patch tests have been perfomed. Several dilutions of EPTAC have been applied in the back of patients with an application time of 24 hrs in general. The results were read 24, 48 and 72h after removal and dermatologist scored the skin reactions.

Positive test results showed that EPTAC is considered as a skin sensitizer.