2,3-epoxypropyltrimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study largely equivalent to the guideline study, conducted without GLP, meeting generally accepted scientific principles and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

abraded/intact skin; occlusive covering

GLP compliance:

no

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:

IUCLID4 Test substance: no data

Test animals

Species:

rabbit

Strain:

other: White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta Werke AG, D-4800 Bielefeld 14, GERMANY
- Age at study initiation: 4-6 months
- Weight at study initiation: 1.8-2.1 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2 (OECD 404 recommends 20 +/- 3; it is possible the conditions might have slightly exceeded this recommendation)
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved; abraded and intact

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): no data given in study report; said in RAR to be 70-75% (the typical commercial aqueous concentration for EPTAC)

VEHICLE
No details

Duration of treatment / exposure:

4 h

Observation period:

observed at 1, 24, 48 and 72 h, and until 14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm2
- % coverage:
- Type of wrap if used: occlusive


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4h


SCORING SYSTEM: Draize. Only data from intact sites are scored for the irritation index

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks:

erythema and oedema

Basis:

mean

Remarks:

of three animals

Time point:

other: 1, 24, 48, 72 h

Score:

0

Max. score:

8

Remarks on result:

other: intact sites; occluded cover

Irritant / corrosive response data:

No erythema or oedema at any observation time (1, 24, 48, 72 h).

Any other information on results incl. tables

All the individual scores were zero at all time points (1, 24, 48 and 72 h)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study, conducted in a manner largely similar to OECD 404 but with no evidence of GLP status, found the test material to be not irritant when in occluded contact with intact rabbit skin for 4 h. The concentration of the applied test material was indentified in the report.