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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidelines and to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cashew Nutshell Liquid (CNSL) Distilled
- Lot/batch No.: ME-0163
- Other: Dark amber coloured liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
pre-enucleation, post equilibration and 60, 120, 180, and 240 minutes following treatment.
Number of animals or in vitro replicates:
In vitro - 3 eyes and 2 control eyes.
Details on study design:
It is a legal and ethical duty under the Animals (Scientific Procedure) Act 1986 that in the interest of animal welfare, the unnecessary use of animals is avoided, and that any testing which is likely to produce severe responses in animals is minimised.
Available informaiton indicated that the test material had the potential to produce severe effects in a rabbit eye and to confirm this initial assessment, a Rabbit Enucleated Eye Test was performed.
A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The assay has undergone inter-laboratory validation and has been shown to reliably detect test materials that are negligible, or moderate to severe ocular irritants.
The New Zealand White strain rabbit used in these laboratories has been shown to produce satisfactory responses using known ocular-irritants and non-ocular irritants during in-house validation. The results of the study are believed to be of value in predicting the ocular irritancy potential of the test material in man.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Value:
>= 4
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Irritation parameter:
fluorescein retention score
Value:
>= 4
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Irritation parameter:
percent corneal swelling
Value:
>= 25
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Other effects / acceptance of results:
The data for all endpoints w as assessed and an estimate of the test material ocular irritancy potential w as made based on the follow ing cut-off values:
REET Parameter REET cut-off value
Maximum Corneal Opacity > = 4
Maximum fluorescein uptake > = 4
Mean corneal swelling > = 25%
Corneal epithelium observations Any pitting, mottling or sloughing

Any other information on results incl. tables

Moderate loss of transparency was noted in all test eyes during the study.

Corneal swelling of the test eyes was considerably greater than that observed in the control eyes over the same period.

Pitting and sloughing of the corneal epithelium was noted in all test eyes during the study.

Moderate fluorescein uptake was noted in the test eyes 240 minutes following test material applicaiton. No fluorescein uptake was noted in the control eyes 240 minutes following treatment.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CNSL, Distilled causes severe irritation to eyes.
Executive summary:

In a rabbit enucleated eye study 0.1 ml of CNSL, Distilled was instilled into three eyes of New Zealand White rabbits. The eyes were observed for 240 minutes. Irritation was scored by the method of McDonald-Shadduck.

Severe eye irritation was observed. In this study, CNSL, Distilled is a severe eye irritant.