1-Octanol, reaction products with epichlorohydrin and 2-mercaptoethanol

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Primary Eye IrritationICorrosion in Rabbits

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

473-730-4

EC Name:

-

Cas Number:

928768-73-4

Molecular formula:

C13H28SO3

IUPAC Name:

1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol

Test material form:

liquid: viscous

Details on test material:

Lot/batch #19381-92

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

New Zealand White rabbits were received from Millbrook Breeding Labs, Amherst, MA on 10/27/04 and equilibrated for at least five days. Only animals in apparent good health were made available for study assignment. Prior to being selected for this study, both eyes of each animal were examined according to the Draize technique for any evidence of irritation or abnormalities of the cornea, iris andlor conjunctiva.
A Mini-Maglite flashlight equipped with a high intensity bulb was used to aid in the examination. Three rabbits (males), free from evidence of ocular irritation or abnormalities, were assigned to this study without conscious bias.
The animals were born the week of 08/08/04. The pretest body weight range was 2.4 - 2.7 kg. The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three
times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum.
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12
hour lightidark cycle and was kept clean and vermin free.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

One eye of each rabbit was dosed. The contralateral eye served as a control. The test article (0.1 ml) was placed by syringe into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test article.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

three males

Details on study design:

Initially, one healthy New Zealand White rabbit (male), free from evidence of ocular irritation and corneal abnormalities, was dosed with the test substance.
The test
article (0.1 ml) was placed into the conjunctival sac of one eye. Based on the reactions of the initial animal, two additional animals (males) were added to the study and dosed in the same manner. The eyes were examined and scored by the Draize technique at 1, 24, 48 and 72 hours and on day 7 postdose in all animals and again on day 14 in the additional two animals. Sodium fluorescein dye procedures were used at the 24, 48 and 72 hour and day 7 observation intervals and again on day 14.
The primary eye irritation score for each rabbit, each day, was calculated.
Body weights were recorded pretest.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

59

Reversibility:

fully reversible

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

14 d

Score:

0

Max. score:

55

Reversibility:

fully reversible

Results 3

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

14 d

Score:

0

Max. score:

55

Reversibility:

fully reversible

Any other information on results incl. tables

Corneal opacity, iritis and conjunctival irritation, noted in 3/3 eyes, cleared by day 7 in the initial animal and by day 14 in the additional animals. There were no abnormal physical signs noted during the observation period.

There were no abnormal physical signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:

other: ocular irritant, but not corrosive

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The tested substance is an ocular irritant, but not corrosive.

Executive summary:

The tested substance is an ocular irritant, but not corrosive.