A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducting according to OECD method by a GLP accredited laboratory.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/EEC, Annex V, Method B5 and OECD guideline for Toxicity Testing of Chemicals, No. 405.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

EC Number:

412-450-9

EC Name:

A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

Cas Number:

131766-73-9

Molecular formula:

C11H20O3

IUPAC Name:

reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three healthy female adult rabbits of the New Zealand White strain were used. Animals weighed 3.6-4.4 kg and were approximately 14 to 16 weeks of age prior to treatment (Day 1). Animals were individually housed in metal cages with perforated floors. Animals had free access to drinking water and SDS Stanrab (P) Rabbit Diet. Animal room temperature was maintained a mean maximum of 18.2°C and a mean minimum of 18.1°C. Mean relative humidity was 50.5%. Air exhange was maintained at approximately 19 air changes per hour and lighting was controlled to give 12 hours light and 12 hours dark in each 24 hour period.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye of the animal remained untreated.

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

After instillation, the test substance remained in the eye.

Observation period (in vivo):

Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of each animal were examined prior to instillation of the test material to ensure that there was no pre-existing corneal damage, iridal or conjunctival inflammation. A 0.1 ml aliquot of the test material 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 and served as a control. All animals were observed daily for signs of ill health or toxic signs. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld light. Grading and scoring of ocular lesions were performed using a numerical scoring system 0-4 for the cornea, iris, conjunctivae and chemosis

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

2

Max. score:

3

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

Corneal opacities developed 1 or 24 hours after instillation in all three animals. The responses persisted 1, 2 or 3 days before resolving. A diffuse crimson-red colouration of the conjunctivae was observed in all three animals. This was accompanied in one animal by obvious swelling with partial eversion of the eyelids. All reactions had resolved four or seven days after instillation. Under the conditions of the study, instillation of 100% test substance into the rabbit eye elicited corneal opacification and slight conjunctival irritation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, instillation of 100% test material into the rabbit eye elicited transient corneal opacification and slight conjunctival irritation. The test substance does not require labelling for eye irritation.