4-chloro-1-methylpiperidinium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Chemical burns of the rabbit cornea.

Author:

Carpenter, C.P., Smyth, H.F.

Year:

1946

Bibliographic source:

American Journal of Ophthalmology 29, 1363–1372, 1946

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of 2-(4-Morpholinyl)ethanol

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-morpholinoethanol

EC Number:

210-734-5

EC Name:

2-morpholinoethanol

Cas Number:

622-40-2

Molecular formula:

C6H13NO2

IUPAC Name:

2-(4-Morpholinyl)ethanol

Test material form:

liquid

Details on test material:

Name of the test chemical: 2-(4-Morpholinyl)ethanol
Common Name: N-(2-Hydroxyethyl)morpholine
Molecular Weight: 131.174 g/mol
Molecular Formula: C6H13NO2
InChI: 1S/C6H13NO2/c8-4-1-7-2-5-9-6-3-7/h8H,1-6H2
Substance Type: Organic
Physical State: Liquid

Specific details on test material used for the study:

Name of the test chemical: 2-(4-Morpholinyl)ethanol
Common Name: N-(2-Hydroxyethyl)morpholine
Molecular Weight: 131.174 g/mol
Molecular Formula: C6H13NO2
InChI: 1S/C6H13NO2/c8-4-1-7-2-5-9-6-3-7/h8H,1-6H2
Substance Type: Organic
Physical State: Liquid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.005 ml. of the undiluted material

Duration of treatment / exposure:

0.005 ml. of the undiluted material is applied to the center of the cornea while the lids are retracted.

Observation period (in vivo):

Eighteen to 24 hours

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

SCORING SYSTEM: 24 hours after the application of the test chemical

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

5

Max. score:

10

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

Severely irritating to rabbit eyes.

Any other information on results incl. tables

Table 1: System for numerical scoring of injury to the rabbit eye 24 hours after application of material

 

Symptoms	Points	Maximum score
Symptom Visible Before Fluorescein Staining
Cornea dull	2
Cornea opaque, less than half of area	4
Cornea opaque, more than half of area	6	6
Keratoconus		6
Iritis, slight internal congestion	1
Iritis, marked internal congestion	2	2
Symptoms visible after fluorescein staining
Necrosis on less than 5% of cornea	1
Necrosis on 5 to12%	2
Necrosis on 12 to 37%	3
Necrosis on 38 to 62%	4
Necrosis on 63 to 87%	5
Necrosis on 88 to 100%	6	6
Total		20

 

Table 2: Grades of injury employed for rating the relative damage produced by chemicals in the eye

Injury grade	Definition
1	0.5 ml undiluted gives injury of 0 to 10 points
2	0.5 ml undiluted gives injury of over 1 up to 5 points
3	0.1 ml undiluted gives injury of up to 5 points (0.5 ml gives over 5)
4	0.02 ml undiluted gives injury of up to 5 points (0.1ml gives over 5)
5	0.005 ml undiluted gives injury of up to 5 (0.02 ml gives over 5)
6	Excess of 40% solution gives injury up to 5 (0.005 ml gives over5)
7	Excess of 15% solution gives injury of up to 5 points (40% gives over 5.0)
8	Excess of 5% solution gives injury of up to 5 points (15% gives over 5)
9	Excess of 1% solution gives injury up to 5 points (5% gives over 5)
10	Excess of 1% solution gives injury up to 5 points

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

A rabbit eye irritation test was conducted to assess the irritation potency of 2-(4-Morpholinyl)ethanol. 2-(4-Morpholinyl)ethanol was grouped under Grade 5 injury (0.005 ml undiluted gives injury of up to 5 (0.02 ml gives over 5)) when rabbit eyes were observed for injuries. Based on the grades, it can be inferred that 2-(4-Morpholinyl)ethanol was severely irritating to rabbit eyes.

Executive summary:

A rabbit eye irritation test was conducted to assess the irritation potency of 2-(4-Morpholinyl)ethanol.

Normal albino rabbit eyes were selected on the basis of absence of grossly visible staining by a 5-percent aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after application. A 2 hour interval was given so that the eye could return back to normal condition. Then, 0.005 ml of the undiluted test material was applied to the center of the cornea while the lids were retracted. About one minute later, the lids were released. This procedure is necessary to prevent the removal of a portion of the dose by the very efficient wiping system of the lids before intimate contact has been made with the eye. 18 to 24 hours later, the eyes were examined in strong diffuse daylight, then stained with fluorescein, and the injury was scored.

2-(4-Morpholinyl)ethanol was grouped under Grade 5 injury (0.005 ml undiluted gives injury of up to 5 (0.02 ml gives over 5)) when rabbit eyes were observed for injuries. Based on the grades, it can be inferred that 2-(4-Morpholinyl)ethanolwas severely irritating to rabbit eyes.