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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978-10-16 until 1978-10-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted similar to OECD guideline 405 (2002). The study was not conducted according to GLP as it was performed prior to its adoption.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No systemic analgesic was applied pretreatment, nor was appropriate topical anesthesia given. In addition not all animals were observed for three full days.
Principles of method if other than guideline:
No systemic analgesic was applied pretreatment, nor was appropriate topical anesthesia given. In addition not all animals were observed for three full days.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Cypress, Cupressus funebris, ext.
EC Number:
285-360-9
EC Name:
Cypress, Cupressus funebris, ext.
Cas Number:
85085-29-6
Molecular formula:
Not applicable due to UVCB nature of the substance
IUPAC Name:
Essential oil of Cedarwood obtained from the wood of Cupressus funebris (Cupressaceae) by steam distillation
Test material form:
not specified
Details on test material:
For specific details on test material if available - See in RSS
- Name of test material (as cited in study report): Cedarwood oil Chinese
- Lot/batch No.: No data
- Purity: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 1-2 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
After applying the product to the rabbits eyes, the irritation reaction is examined 15 minutes later. Subsequently the eyes are monitored at daily intervals untill the treated eyes are considered to be of normal appearance.
Observation period (in vivo):
immedeate, 15 minutes, 24 hours, 48 hours, 72 hours (last timepoint for one rabbit only)
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
No data

SCORING SYSTEM:
The numerical scorings recorded were made differed to a certain extent from the grading scheme of OECD guideline 405. Both grading schemes score ocular lesions (corneal, iridic and conjunctival irritation), but the grading differed (see Table X in attached document).

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0.3
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0.3
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hours
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritant / corrosive response data:
The ocular reactions observed during the study remained slight to moderate and only recorded at the conjunctivae level: all animals had slight conjunctivitis but this was healed on day 3. In addition two animals had turgid swelling in the upper cheek area after 4 hours of treatment. This was no longer evident on day 1.
Other effects:
The authors conclude that the test compound, Cedarwood Chinese, is a slight eye irritant, according to the method they used (Modified Federal Hazardous Substance Labelling Act Method).

Any other information on results incl. tables

It is noted that the 72 -hour reading point is not available, but given the slight effect observed it is not expected that this would change the study outcome. The calculations, as presented in the tabel in the result section, are based on an average of three days. If there was no data for day 3, it was assumed that the score for this day should be 0 (also because in all cases the day before the score was also 0).

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Based on CLP criteria
Conclusions:
In an eye irritation study performed similar to OECD405, Cedarwood Chinese oil did not induce significant or irreversible damage to the rabbit eye. Under the conditions of this test, Cedarwood Chinese oil does not need to be classified for eye irritant in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
Executive summary:

The primary eye irritation potential of Cedarwood Chinese oil was investigated with a test method similar to OECD TG 405 (2002). The test item was applied (0.1 mL undiluted) to one eye of in total 3 New Zealand White rabbits. Eyes were examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes were examined before application of materials and also at daily intervals with a slit lamp, also corneal swelling was measured. The test substance caused a slight opacity, affecting up to 1/2 of the cornea in one animal. All the animals had slight conjunctivitis. All three animals had healed by day three. Two animals had turgid swelling in the upper cheek area, 4 hrs after treatment, which was not evident anymore on day 1. To be able to interpret the results, the grading scheme as used in the study report was converted to the current OECD TG 405 grading scale. After conversion, the mean scores for corneal opacity and iritis were 0, for conjunctival redness in the range of 0.3-0.6, and for conjunctival chemosis in the range of 0-0.3. Based on the results of this test, it was concluded that Cedarwood Chinese oil does not need to be classified for eye irritant in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).