2,3-epoxypropyltrimethylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: EU Risk Assessment report

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:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

no detail

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): no data

VEHICLE
not applicable

Duration of treatment / exposure:

the test substance was instilled and not rinsed. The scoring was performed at 1; 24; 48 and 72 hrs after the beginning of the treatment.

Observation period (in vivo):

within 21 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable as no rinsing is done.
- Time after start of exposure: not applicable

SCORING SYSTEM: draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

1.7

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

1

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

1

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

2

Max. score:

2

Reversibility:

other: in one animal, congestion of the iris is irreversible

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

1.3

Max. score:

2

Reversibility:

other: In one animal, congestion of the iris was irreversible

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

2

Max. score:

2

Reversibility:

other: In one animal, congestion of the iris was irreversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

3

Max. score:

3

Reversibility:

not specified

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

3

Max. score:

3

Reversibility:

not specified

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

3

Max. score:

3

Reversibility:

not specified

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

2.7

Max. score:

4

Reversibility:

not specified

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

1.7

Max. score:

4

Reversibility:

not specified

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

Mean individual score

Time point:

other: Overall 24, 48 and 72 hrs

Score:

3

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

See details in table 7.3.2/1. In one animal, congestion of the iris persisted after the 21 day observation period. There was no detail on the reversibility of the other analysed parameters (cornea, conjunctivae and chemosis)

Other effects:

no data.

Any other information on results incl. tables

Table 7.3.2/1: Scores obtained after an instillation of EPTAC into the right conjunctival sac of the 3 rabbits.

 

Score at time point	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	1.7/1.0/1.0	2.0/1.3/2.0	3.0/3.0/3.0	2.7/1.7/3.0

 

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:

Under the test conditions, the test substance is classified as Eye Dam. 1 (H318, Causes serious eye damage) according to the CLP regulation (No. 1272/2008) and as Risk of serious damage to eyes (Xi, R41) according to the Directive 67/548/EEC.

Executive summary:

In an eye irritation study (Degussa, 1986a) performed according to the OECD guideline No. 405 protocol, 0.1 mL of a commercial solution (referred as QUAB 151) of 2,3-epoxypropyltrimethyl ammonium chloride (purity assumed to be 70-75%) (EPTAC) was instilled into the conjunctival sac of the right eye of three albino rabbits. No rinsing was performed. Cornea, iris and conjunctiva was examined and scored qualitatively and quantitatively after 1, 24, 48 and 72 hours. The rabbits were then observed for 21 days. EPTAC was severely irritating to eyes considering the scores obtained for the iris lesion (> 1.5). Furthermore, the effect on iris was persistent within 21 days in one animal which is also a criterion to classify the test substance as severe irritating to eyes.

 

Therefore, under the test conditions, EPTAC is classified as Eye Dam. 1 (H318, Causes serious eye damage) according to the CLP regulation (No. 1272/2008) and as Risk of serious damage to eyes (Xi, R41) according to the Directive 67/548/EEC.