Reaction mass of 2,4-dimethyl-6-phenyl-3,6-dihydro-2H-pyran and 2-methyl-4-methylene-6-phenyltetrahydro-2H-pyran and 4,6-dimethyl-2-phenyl-3,6-dihydro-2H-pyran

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

The study was conducted between 30 May 1977 and 16 June 1977.

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Modified Federal Hazard Substances labelling Act Method

Deviations:

no

GLP compliance:

no

Remarks:

Study pre-dates GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,4-dimethyl-6-phenyl-3,6-dihydro-2H-pyran and 2-methyl-4-methylene-6-phenyltetrahydro-2H-pyran and 4,6-dimethyl-2-phenyl-3,6-dihydro-2H-pyran

Molecular formula:

C13H160

IUPAC Name:

Reaction mass of 2,4-dimethyl-6-phenyl-3,6-dihydro-2H-pyran and 2-methyl-4-methylene-6-phenyltetrahydro-2H-pyran and 4,6-dimethyl-2-phenyl-3,6-dihydro-2H-pyran

Test material form:

other: Liquid

Details on test material:

Name: Pelargene
Chemical name: 2,4-dimethyl-6-phenyldihydropyran
Appearance: Colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

No data

Observation period (in vivo):

22 days

Number of animals or in vitro replicates:

Three

Details on study design:

Test substances are applied to one eye each of three rabbits by gently pulling the lower lid away from the eyeball and placing 0.1 mL in the sac so formed. Standards for comparison are applied to further rabbits in the same manner.
Eyes are examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes are examined before application of the materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.

Modification of standard method
Area of cornea and iris affected was assessed as well as intensity.

Results and discussion

In vivo

Irritant / corrosive response data:

The test substance, as supplied, caused no corneal, conjunctival or iridial lesions when assessed at 24 h. One rabbit showed signs of discomfort when treated.

Any other information on results incl. tables

Summary of results

Substance	No. of rabbits	Number of rabbits with stated ocular lesion
		Discomfort	Positive conjunctival reactions (1)	No. with iritis	No with pannus	Corneal opacity grade (2)					Duration (3)		Maximum corneal swelling % (4)
						0.5	1	2	3	4	Opacity≥1 Day 8	Opacity≥0.5 day 22	-10 % to +19 %	+ 20 % to +39 %	+40 % to +59 %	+60 % to + 79 %	+80 % to + 79 %	+100 %
Test substance	3	1	-	-	-	-	-	-	-	-	-	-	3

1)   Positive conjunctival reactions – number of rabbits with conjunctival erythema or chemosis grades ≥2.

2)     Corneal opacity - maximum grade obtained during period of observation.

3)     Duration – number of animals with corneal opacity grades ≥1 on 8^thday of observation or with any ocular lesions on the 22^ndday of the test.

4)     Corneal swelling - maximum swelling attained during period of observation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance, as supplied, is not an eye irritant. This material may cause pain if accidentally splashed into the eye.

Executive summary:

The test substance was assessed for eye irritation using an in vivo method. The test substance, as supplied, caused no corneal, conjunctival or iridial lesions when assessed at 24 h. One rabbit showed signs of discomfort when treated.