1-Propanol, 2-methyl-3-[(1,7,7-trimethylbicyclo[2.2.1]hept-2-yl)oxy]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 15 March and 05 April 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-210-4

EC Name:

-

Cas Number:

128119-70-0

Molecular formula:

C14H26O2

IUPAC Name:

2-methyl-3-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-1-ol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
The animals were in the weight range of 3.6 to 3.9 kg and approximately 15 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in plastic cages with perforated floors in Building R 14 Room 1.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
The batch of diet used for the study was not analysed for nutrients, contaminants or microorganisms.
Results of routine chemical examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly summaries.
Animal room temperature was maintained at approximately 19 QC and relative humidity at 30 - 70 %. These environmental parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear.
This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage, was identified by a coloured label displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A 0.1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal.

Observation period (in vivo):

Up to 21 days

Number of animals or in vitro replicates:

3 (One animal was treated in advance of the others, to ensure that if a severe response was produced no further animals would be exposed)

Details on study design:

TREATMENT PROCEDURE
The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation. One animal was treated in advance of the others, to ensure that if a severe response was produced no further animals would be exposed. A 0.1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.

OBSERVATIONS
- Clinical signs: All animals were observed daily for signs of ill health or toxicity.
- Ocular responses: Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4, 7, 14 and 21 days after instillation. Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1606

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 d

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 1607 and 1608

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

iris score

Basis:

animal: 1606 and 1607

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

iris score

Basis:

animal: 1608

Time point:

24/48/72 h

Score:

0.667

Reversibility:

fully reversible within: 72 hrs

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 1606

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 d

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: 1607

Time point:

24/48/72 h

Score:

2.333

Max. score:

3

Reversibility:

fully reversible within: 14 d

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: 1608

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 8

Irritation parameter:

chemosis score

Basis:

animal: 1606

Time point:

24/48/72 h

Score:

1.333

Max. score:

4

Reversibility:

fully reversible within: 4 d

Results 9

Irritation parameter:

chemosis score

Basis:

animal: 1607

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal: 1608

Time point:

24/48/72 h

Score:

1.333

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

- Corneal opacification developed in all three animals together with stripping of the corneal surface.
- Vascularisation of the sclera was seen four days after instillation in one animal (1607 male).
- Iridial inflammation was seen in all three animals.
- A diffuse crimson or beefy red colouration of the conjunctivae, accompanied by obvious swelling with partial eversion of the eyelids was observed in all three animals.
- The eyes were normal 7, 14 or 21 days after instillation.

Other effects:

CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Table 1                       Ocular Reactions observed after instillation of Bornafix

Rabbit no. and sex	Region of eye		One hour	Day after instillation
				1	2	3	4	7	14	21
1606 male*	Cornea		a1	a2	a2	a2	a2	1	1	0
	Iris		0	1	1	1	1	0	0	0
	Conjunctiva	Redness	2	2	2	2	2	1	1	0
		Chemosis	1	2	1	1	0	0	0	0
1607 male	Cornea		aD	1	1	1	b1	0	0
	Iris		0	1	1	1	1	0	0
	Conjunctiva	Redness	2	2	2	3	2	2	0
		Chemosis	1	2	2	2	2	0	0
1608 male	Cornea		aD	1	1	1	1	0
	Iris		0	1	1	0	0	0
	Conjunctiva	Redness	2	2	2	2	2	0
		Chemosis	1	2	1	1	1	0

* Pilot animal

a Stripping of epithelial cells

b Vascularisation of the sclera

D Dulling of the normal lustre of the cornea

Applicant's summary and conclusion

Interpretation of results:

other: The substance is an eye irritant Cat 2 according to EU CLP (1272/2008 and its amendments)

Conclusions:

The substance is considered to be irritating to eyes Category 2

Executive summary:

A study according to OECD 405 was performed to assess the eye irritation potential of Bornafix to the rabbit. Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for a maximum of 21 days after instillation. A single instillation of Bornafix into the eye of the rabbit elicited corneal opacification, iridial inflammation and well-defined to moderate conjunctival reactions. All reactions had resolved 7, 14 or 21 days after instillation. It is concluded that Bornafix is irritant to the rabbit eye.