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Toxicological information

Eye irritation

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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

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 8thday of observation or with any ocular lesions on the 22ndday 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.