2,3-epoxypropyltrimethylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted without GLP, meeting generally accepted scientific principles and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

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 / tissue source

Species:

rabbit

Strain:

other: White Russain

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Asta Werke AG, D-4800 Bielefeld 14, GERMANY
- Age at study initiation: 7 months
- Weight at study initiation: 1.9-2.15 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2 (OECD 405 recommends 20 +/-3; it is possible that the temperature might slightly have exceeded that recommended)
- Humidity (%): 55 +/1 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1985-03-12 To: 1985-04-1

Test system

Vehicle:

not specified

Controls:

other: untreated eye serves as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): not stated presumed to be 70-75% aqueous (QUAB 151 as supplied)

Duration of treatment / exposure:

Unrinsed. Scored at 1-71 h

Observation period (in vivo):

Scored at 1, 24, 48, 72 h and observed to 21 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): un washed

SCORING SYSTEM: draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean of 24, 48 and 72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean of 24, 48 and 72 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean of 24, 48 and 72 h

Score:

1.8

Max. score:

2

Reversibility:

not fully reversible within: 21 days in 1 animal

Results 4

Irritation parameter:

cornea opacity score

Remarks:

clouding

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean of 24, 48 and 72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	2,1,1	2,2,2	3,3,3	2,1,3
48 h	1,1,1	2,1,2	3,3,3	3,2,3
72 h	2,1,1	2,1,2	3,3,3	3,2,3
Average 24h, 48h, 72h	2.7,1.0,1.0	2.0,1.3,2.0	3,3,3	2.7,1.7,3.0
Category 1 (irreversible eye effects)	-	2/3 animals >=1.5 (mean for 24, 48 and 72 h)	-	-
Reversibility*)	nd	n, by 21 days	Nd	nd

*) Reversibility: nd = no data; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A generally reliable study, conducted according to OECD 405 but without GLP, reported severe irritation to the eyes of rabbits the effects of which had not entirely reversed after 21 days. The concentration of the test material was not stated, however as commercial grade of QUAB151 it was assumed to be in the range 70-75% aqueous.