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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed according to US-FHSA guideline. Study comparable to test guideline OECD No. 405. No details on test animals and environmental conditions. Effects observed were not fully reversible within 7 days but a beginning of recovery was observed and, based on an expert judgment, a full reversion can be expected within an observation period of 21 days.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, p. 27019, 27 September 1973.
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP

Test material

Constituent 1
Reference substance name:
Juniper, Juniperus mexicana, ext., epoxidized
EC Number:
309-066-8
EC Name:
Juniper, Juniperus mexicana, ext., epoxidized
Cas Number:
99811-75-3
Molecular formula:
not applicable (UVCB substance)
IUPAC Name:
(1S,2R,5S,7R)-2,6,6,8-tetramethyltricyclo[5.3.1.0¹,⁵]undecan-9-one; (1aS,2R,4aS,8aS)-2,4a,8,8-tetramethyl-decahydrocyclopropa[e]naphthalen-3-one; (1aS,2S,4aS,8aS)-2,4a,8,8-tetramethyl-decahydrocyclopropa[e]naphthalen-3-one
Test material form:
not specified
Details on test material:
No data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: Healthy young adult albino rabbits were used.

IN-LIFE DATES: From July 09 to 16, 1979

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Test material was not washed from the eyes.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
Test material was not washed from the eyes.

SCORING SYSTEM: According to “Illustrated guide for grading eye irritation by hazardous substances”.

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 & #6
Time point:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: #3 & #4
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: mean 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: #1, #2
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: mean 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: mean 24, 48 and 72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: mean 24, 48 and 72 h
Score:
1.67
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3 & #6
Time point:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean 24, 48 and 72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: mean 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: mean 24, 48 and 72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: mean 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Animals showed corneal, iridal and conjunctival reactions (redness, chemosis and discharge) which were not reversible in 7 days observation period.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Eye irritation response data for each animal at each observation time

 

Score at time

point

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

24 h (Day 1)

2 / 2 / 1 / 1 / 2 / 2

3 / 4 / 4 / 4 / 4 / 4

1 / 1 / 1 / 2 / 2 / 2

2 / 2 / 2 / 3 / 2 / 2

4 / 4 / 2 / 3 / 3 / 3

3 / 3 / 3 / 3 / 3 / 3

48 h (Day 2)

2 / 2 / 1 / 1 / 2 / 2

4 / 4 / 4 / 4 / 4 / 4

1 / 1 / 1 / 1 / 2 / 1

2 / 2 / 2 / 3 / 2 / 2

3 / 4 / 1 / 3 / 2 / 3

3 / 3 / 2 / 3 / 3 / 3

72 h (Day 3)

2 / 2 / 1 / 1 / 1 / 2

4 / 4 / 4 / 4 / 4 / 4

1 / 1 / 1 / 1 / 1 / 2

2 / 2 / 2 / 2 / 2 / 2

3 / 4 / 2 / 2 / 2 / 2

3 / 3 / 2 / 2 / 3 / 3

Day 5

1 / 2 / 1 / 1 / 1 / 1

4 / 4 / 4 / 4 / 4 / 4

1 / 1 / 1 / 1 / 0 / 1

2 / 2 / 1 / 1 / 1 / 1

2 / 2 / 1 / 1 / 0 / 1

2 / 2 / 2 / 1 / 1 / 1

Day 7

1 / 1 / 0 / 0 / 0 / 1

4 / 4 / 0 / 0 / 0 / 4

1 / 1 / 0 / 0 / 0 / 1

2 / 1 / 1 / 0 / 0 / 1

2 / 1 / 0 / 0 / 0 / 1

2 / 1 / 0 / 1 / 0 / 1

Average 24, 48 and 72 h

2.00 / 2.00 / 1.00 / 1.00 / 1.67 / 2.00

3.67 / 4.00 / 4.00 / 4.00 / 4.00 / 4.00

1.00 / 1.00 / 1.00 / 1.33 / 1.67 / 1.67

2.00 / 2.00 / 2.00 / 2.67 / 2.00 / 2.00

3.33 / 4.00 / 1.67 / 2.67 / 2.33 / 2.67

3.00 / 3.00 / 2.33 / 2.67 / 3.00 / 3.00

Reversibility

Not reversible

Not reversible

Not reversible

Not

reversible

Not reversible

Not reversible

Average time (unit) for reversion

-

-

-

-

-

-

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test material has a classification of Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) No. 1272/2008 (CLP).
Executive summary:

In an eye irritation study performed similarly to OECD guideline No. 405, 0.1 g of undiluted test material was instilled into the right eye of 6 albino rabbits while the left eye remained untreated and served as control. Test material was not washed from the eyes. Animals were observed at 24, 48 and 72 h after instillation of test material into eyes and then on Days 5 and 7. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the “Illustrated guide for grading eye irritation by hazardous substances”.

 

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 2.00 / 2.00 / 2.00 / 2.67 / 2.00 / 2.00 for redness, 3.33 / 4.00 / 1.67 / 2.67 / 2.33 / 2.67 for chemosis, 1.00 / 1.00 / 1.00 / 1.33 / 1.67 / 1.67 for iris lesions and 2.00 / 2.00 / 1.00 / 1.00 / 1.67 / 2.00 for corneal opacity.

Those scores do not allow to classify the substance for serious eye damage (0/6 rabbits show a mean score per animal of ≥ 3 for corneal opacity and 2/6 animals show a mean score per animal of > 1.5 for iritis). Animals showed corneal and conjunctival reactions (redness, chemosis and discharge) which were not fully reversible within 7 days but the observation period was only 7 days instead of 21 days in current in vivo studies and a beginning of recovery was observed and, based on an expert judgment, a full reversion can be expected within an observation period of 21 days. Therefore, based on the effects observed and the measured scores, the substance is a severe eye irritant.

 

Under the test conditions, the test material has a classification of Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) No. 1272/2008 (CLP).

 

Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.