4-methylpyridine

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: Cosmetic guideline study with no information on GLP

Data source

Reference

Reference Type:

publication

Title:

Eye and Skin Irritation Induced by Picolines

Author:

H. DUTERTRE-CATELLA, N. PHu-LIeH, V. N. HUYEN, L. ÜLIVIER,
R. TRUHAUT, and J.-c. CLAUDE

Year:

1989

Bibliographic source:

Biological Monitoring of Exposure and the Response at the Subcellular Level to Toxie Substances
Arch. Toxico!., Supp!. 13, 428-432

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: French Journal Officiel 1984

Principles of method if other than guideline:

French official protocol after the method of: Draize JH, Woodard G and Calvery HO, 1944. Methods for the study of irritation and toxicity of stubstances applied topically to the skin and mucous membranes. J. Pharmacol Exp Therap 82:377-390.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-methylpyridine

EC Number:

203-626-4

EC Name:

4-methylpyridine

Cas Number:

108-89-4

Molecular formula:

C6H7N

IUPAC Name:

4-methylpyridine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Amount / concentration applied:

6 male New Zealand albino rabbits were obtained from CEGAV, 61350 Saint-Mars-d'Egrenne and weight 2.5 kg at the beginning of the study. They were housed inidvidually in wire mesh cages and fed on a commercial diet with tap water ad libitum. They were kept at least one week for acclimatization prior to testing. Animals were sacrificed after 7 or 14 days.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

Test material (0.1 ml) is instilled into the conjunctival sac and the eye is held closed for 10 seconds. The animals are held in a holding device for 1 hour, and then returned to their cages. Readings are made at 1 hour and also at 1, 2, 3, 4 and 7 days after instillation. Aqueous fluorescein 2%, preferably freshly prepared, is used to inspect the eye, together with a flashlight and ophthalmology UV lamp lens

In this study, histopathological examination of the exposure sites took place on the 7th day. In this study, treatment of the eyes and skin occured in the same animals. Eyes were fixed in 10% neutral buffered formalin and skin in Bouin's solution. Sections of tissues were stained with hematoxilin-eosin-saffron.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Time point:

24/48/72 h

Remarks on result:

not determinable

Results 2

Irritation parameter:

conjunctivae score

Time point:

24/48/72 h

Remarks on result:

not determinable

Results 3

Irritation parameter:

iris score

Time point:

24/48/72 h

Remarks on result:

not determinable

Results 4

Irritation parameter:

cornea opacity score

Time point:

24/48/72 h

Remarks on result:

not determinable

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

58

Max. score:

110

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: severe irritation

Irritant / corrosive response data:

Data on individual animals is not available, nor is the IOI (the sum of the scores for each animal at the various time points, which provides an indication of individual variation.
For pyridine, the maximum irritation occured at one hour with a score of 43, which is evaluated as an "irritant". It is noted that there was individual variation, with a few rabbits recovering completely while the lesions of others got worse between the first and last reading. Because overall recover is poor, the category of irritation is increased to "severely" in the text. However, this is not defined in the 1982 grading system

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

4-Methylpyridine was tested for eye irritation in the official French protocol (based on a Draize scale) in rabbit, and found to be "very irritating or severely irritating".

Executive summary:

The eye irritation of the test item has been tested in accordance with French official protocol after the method of: Draize JH, Woodard G and Calvery HO, 1944.

Test material was instilled into the conjunctival sac of 6 males from New Zealand albino rabbits and was found  to be "very irritating or severely irritating".