Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
An available In vivo study were sufficient to allow us to filled this endpoint and determined the classification.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The techniques of tests as published by the FDA of the US (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) are followed.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
EC Number:
246-099-6
EC Name:
2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran
Cas Number:
24237-01-2
Molecular formula:
C11H20O
IUPAC Name:
2-butyl-4,6-dimethyl-3,6-dihydro-2H-pyran
Constituent 2
Chemical structure
Reference substance name:
6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
EC Number:
246-098-0
EC Name:
6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran
Cas Number:
24237-00-1
Molecular formula:
C11H20O
IUPAC Name:
6-butyl-2,4-dimethyl-3,6-dihydro-2H-pyran
Constituent 3
Chemical structure
Reference substance name:
2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
EC Number:
246-101-5
EC Name:
2-butyltetrahydro-6-methyl-4-methylene-2H-pyran
Cas Number:
24237-02-3
Molecular formula:
C11H20O
IUPAC Name:
2-butyl-6-methyl-4-methylenetetrahydro-2H-pyran
Specific details on test material used for the study:
Material Identification (as stated in the report) : Gyrane U 05315
Appearance: Clear colorless liquid
Sample received on 8th, March 1983

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually housed

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
The test material was examined pure and undiluted in six rabbits.
Controls:
other: the other eye remaining intreated, serves as control
Amount / concentration applied:
TEST MATERIAL- Amount applied: 0.1 mL
Duration of treatment / exposure:
Single instillation on Day 1.
Observation period (in vivo):
The eyes of each animal were examined approximately 7 days after instillation of the test substance.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
STUDY DESIGN
0.1 mL of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.

REMOVAL OF TEST SUBSTANCE
The eyes are not washed following instillation and the animals are released immediately.

OBSERVATIONS
The eyes of each animal were examined approximately 24, 48 and 72 hours and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 3, 4, 5, and 6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: score 0
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3, 4, 5, and 6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: score 0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 4, 5 and 6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: score 0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 1 and 2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 1, 3 and 4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: score 0
Irritation parameter:
chemosis score
Basis:
animal: 2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 5 and 6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
After 24 hours the eye effects caused by the test substance consisted of slight redness of the conjunctivae in five out of six animals and slight swelling of the conjunctivae in three out of six animals. Up to day 7 some of these effects cleared up completely. However, after 7 days slight redness of the conjuctivae was still seen in three out of six animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline, Gyrane caused slight redness and slight swelling of the conjunctivae in the animals. Nevertheless the test results do not meet the critera to be classified for skin irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances.
Executive summary:

Gyrane was tested in an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline.

Eye effects caused by the test substance consisted of slight redness of the conjunctivae in five out of six animals and slight swelling of the conjunctivae in three out of six animals. Up to day 7 some of these effects cleared up completely. However, after 7 days slight redness of the conjuctivae was still seen in three out of six animals.

Although the observation period was not extended it is assumed that after 21 days the effects observed (only redness of the conjunctivae) will be reversible. The test material does not meet the critera to be classified for skin irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances according to this test.