2,3-epoxypropyltrimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: EU Risk Assessment

Adequacy of study:

other information

Study period:

No data

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

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other 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

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

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

Details on test material:

- Name of test material (as cited in study report): commercial preparation of EPTAC (QUAB 151)
- Analytical purity: varies between 70 and 75%

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

no detail

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact or abraded skin

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 70-75%

VEHICLE
no data

Duration of treatment / exposure:

4h

Observation period:

1; 24; 48; 72 hours after the treatment

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: The sample was instilled on 4 separate shaved locations of the back of animals. One side of the back, the skin was abraded while the other remained intact.
- % coverage: no data
- Type of wrap if used: occlusive (no more detail)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM:

Results and discussion

In vivo

Irritant / corrosive response data:

At all time observation points (1; 24; 48 and 72 hrs), all individual scores were 0.00 for the intact aeras treated with EPTAC.

Other effects:

No data

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test item is not classified as irritating to skin according to the criteria of the CLP regulation (No. 1272/2008) and of the Directive 67/548/EEC.

Executive summary:

In a skin irritation study (Degussa, 1985), considered as a Key study and performed similarly to the OECD guideline No. 404, three albino rabbits were exposed to 0.5 mL of the commercial preparation of 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) (referred as QUAB 151) for 4h under occlusive patch. The concentration was assumed varying between 70 and 75%.

The test sample was instilled on four separate shaved locations. One side of the back the skin was abraded while the other remained intact. For the calculation of irritation index, the scores from the intact areas were included only. The scoring was done within 1, 24, 48 and 72 hours after the end of the treatment. All the individual scores of the non-abraded skin treated with EPTAC were zero at all time points.

 

Another study was available (Degussa, 1981c) where the irritating properties of 2,3-epoxypropyltrimethyl ammonium chloride at 72% were investigated on 12 albino rabbits. On six rabbits, 0.5 mL of the test substance was instilled on an intact clipped area which was covered with a 1 sq. inch patch. Another group of six rabbits received the 0.5 mL of the substance on a skin area with slight abrasions to the stratum cornea, again covered with a patch wrapped with adhesive tape. Exposure time was 24 hours. Draize-scoring was used to calculate the irritation index at 24 and 72 hours after application on intact and abraded skin. The skin irritation effects were described as severe. They included well-defined erythema, slight ischemia, haemorrhages and slight to distinct incrustation and slight to moderate oedema. The average 24-h score on intact skin was 4.3 and 3.8 after 72 h and for abraded skin 6.3 both at 48 and at 72 hours. However, these positive results (evidence of a skin irritation) were obtained with worst case experimental conditions such as occlusive patch method and an exposure duration of 24h instead of a 4h exposure under semi-occlusive conditions according to the requirements of the current OECD guideline. Therefore, the results of this study are not considered to be relevant to draw a conclusion on skin irritation of EPTAC.

 

In conclusion, considering the results obtained in the Key study, the test item is not classified as irritating to skin according to the criteria of the CLP regulation (No. 1272/2008) and of the Directive 67/548/EEC.