1-methylpiperidine

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: see 'Remark'

Remarks:

Comparable to OECD guideline study. Acceptable, well documented report which meets basic scientific principles. Study was conducted before establishment of the OECD Test Guideline, but study protocol is in principle similar to OECD TG 405, with acceptable restrictions (only 50 µL instilled, only 2 animals used, observation period only 8 days).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Only 50 µL instilled, only 2 animals used, observation period only 8 days.

Principles of method if other than guideline:

Standardized test method (BASF-Test)
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 50 µL of the test substance were applied to the conjunctival sac of one eye each in 2 animals. The saline-treated adjacent eye served as control. The animals were observed after 10 min, 1 and 3 h on the day of treatment and daily up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-methylpiperidine

EC Number:

210-959-9

EC Name:

1-methylpiperidine

Cas Number:

626-67-5

Molecular formula:

C6H13N

IUPAC Name:

1-methylpiperidine

Details on test material:

- Name of test material (as cited in study report): Methylpiperidine
- Physical state: liquid
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.72 and 3.3 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as saline control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days
Reading time points: 10 min, 1, 24, 48 and 72 h and 8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

3.5

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Both animals had purulent clotty eyes and crusts at the eye lid 8 days after treatment.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

 

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	10 min	2	1	0	3
	1 h	2	2	0	3
	3 h	2	2	0	3
	24 h	2	2	0	0
	48 h	2	2	0	0
	72 h	0	2	0	0
	8 days	0	0	0	0
	average	1.3	2.0	0.0	0.0
2	10 min	0	0	0	0
	1 h	0	0	0	3
	3 h	2	2	0	0
	24 h	2	3.5	0	0
	48 h	2	3.5	0	0
	72 h	0	3.5	0	0
	8 days	0	0	0	0
	average	1.3	3.5	0.0	0.0

 

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes)

Remarks:

Migrated information