1-methylpiperidine-2-ethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Intercompany communication outlining the contents of a test report. The given data allows the conclusion that the study was well-performed, is sufficiently reliable and conclusions on classification can be drawn, too.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Guideline not explicitly mentioned, but given data indicates that testing was performed similar to OECD 405

Deviations:

not applicable

Principles of method if other than guideline:

New Zealand White rabbits had 0.1 mL of MPA (n-Methyl-piperidy1-2-ethan-2-ol) instilled into one eye respectively.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-methylpiperidine-2-ethanol

EC Number:

208-554-7

EC Name:

1-methylpiperidine-2-ethanol

Cas Number:

533-15-3

Molecular formula:

C8H17NO

IUPAC Name:

2-(1-methylpiperidin-2-yl)ethanol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report) : MPA ; (n-Methyl-piperidy1-2-ethan-2-ol)
- Physical state : liquid
- Analytical purity : no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No details available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.1 mL

Duration of treatment / exposure:

single application, duration not specified

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

9 male animals

Details on study design:

Nine healthy male New Zealand White rabbits had 0.1 mL of MPA (n-Methyl-piperidyl-2-ethan-2-ol) instilled into one eye respectively. The eyelids were held together for 2 to 3 seconds to prevent loss of test material. The opposite eye served as a control respectively. The treated eyes of six animals remained unwashed; the remaining three animals with treated eyes were washed with 100 mL of lukewarm tap water 20 seconds after instillation of the test material into the eye. Ocular examination using 2% fluorescein and ultraviolet light were made at 24, 48 and 72 hours and 4, 7 and 14 days post treatment. Individual Body weights were taken at pretest 24 hours and 7 and 14 days post treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

no wash-out

Basis:

mean

Time point:

other: daily over 14 days

Score:

>= 70.5 - <= 90.7

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: average daily eye indication scores were the greatest at Day 14

Remarks:

In the severity and persistence of eye observations, the test item is judged as corrosive

Results 2

Irritation parameter:

overall irritation score

Remarks:

wash-out

Basis:

mean

Time point:

other: daily over 14 days

Score:

>= 50 - <= 92.7

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: average daily eye indication scores were the greatest at Day 14

Remarks:

In the severity and persistence of eye observations, the test item is judged as corrosive

Irritant / corrosive response data:

All nine animals showed opalescent corneal areas where the iris was invisible 14 days post instillation of the test material into the eye. In addition, observation of the iris was not even possible in any of the nine animals 14 days post administration of the test material. As well, severe conjunctival reactions were observed in all animals during the study. The average daily eye index scores calculated for those animals where the eyes remained unwashed ranged from 70.5 to 90.7. Those animals having the eye washed showed average eye index scores ranging from 50.0 to 92.7. It is significant that the average daily eye indication scores were the greatest at Day 14 post administration of the test material.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Conclusions:

The study was considered to be of sufficient reliability (reliability Klimisch 2), because, although only slightly limited information available, the available indicates that the study was properly performed. Based on the results of this study, this compound would be classified as an eye irritant. More importantly, however, based on the results of this study, in the severity and persistence of eye observations observed, this test material will be judged as a corrosive.

Executive summary:

The test substance MPA (n-Methyl-piperidyl-2-ethan-2-ol) was investigated for its potential to cause irritation in the rabbit eye. Nine healthy male New Zealand White rabbits had 0.1 ml of MPA (n-Methyl-piperidyl-2-ethan-2-ol) instilled into one eye respectively. The eyelids were held together for 2 to 3 seconds to prevent loss of test material. The opposite eye served as a control respectively. The treated eyes of six animals remained unwashed; the remaining three animals with treated eyes were washed with 100 ml of lukewarm tap water 20 seconds after instillation of the test material into the eye. Ocular examination using 2% fluorescein and ultraviolet light were made at 24, 48 and 72 hours and 4, 7 and 14 days post treatment. Individual Body weights were taken at pretest 24 hours and 7 and 14 days post treatment. All nine animals showed opalescent corneal areas where the iris was invisible 14 days post instillation of the test material into the eye. In addition, observation of the iris was not even possible in any of the nine animals 14 days post administration of the test material. As well, severe conjunctival reactions were observed in all animals during the study. The average daily eye index scores calculated for those animals where the eyes remained unwashed ranged from 70.5 to 90.7. Those animals having the eye washed showed average eye index scores ranging from 50.0 to 92.7. It is of significance that the average daily eye indication scores were the greatest at Day 14 post administration of the test material.

Based on the results of this study, this compound would be classified as an eye irritant. More importantly, however, based on the results of this study, in the severity and persistence of eye observations observed, this test material will be judged as a corrosive.