Registration Dossier
Registration Dossier
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EC number: 700-991-6 | CAS number: 8007-24-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted to OECD guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Rabbit Enucleated Eye Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-[(7Z)-pentadec-7-en-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10,14-trien-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10-dien-1-yl]phenol; 3-pentadecylphenol
- EC Number:
- 700-991-6
- Cas Number:
- 8007-24-7
- Molecular formula:
- Cardanol (saturated side chain): Formula: C21 H36 O Cardanol (monoene): Formula: C21 H34 O Cardanol (diene): Formula: C21 H32 O Cardanol (triene): Formula: C21 H30 O
- IUPAC Name:
- 3-[(7Z)-pentadec-7-en-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10,14-trien-1-yl]phenol; 3-[(7Z,10Z)-pentadeca-7,10-dien-1-yl]phenol; 3-pentadecylphenol
- Details on test material:
- - Name of test material (as cited in study report): Cashew Nutshell Liquid (CNSL) Distilled (Distilled grade)
- Lot/batch No.: ME-0163
- Other: Dark amber coloured liquid
Constituent 1
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 information 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
- Run / experiment:
- Test eye #1 60 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #1 120 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #1 180 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #1 240 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #2 60 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #2 120 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #2 180 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #2 240 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #3 60 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #3 120 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #3 180 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test eye #3 240 minutes
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #1 60 minutes
- Value:
- 12.7
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #1 120 minutes
- Value:
- 26.2
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #1 180 minutes
- Value:
- 39.3
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #1 240 minutes
- Value:
- 69.6
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #2 60 minutes
- Value:
- 12.3
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #2 120 minutes
- Value:
- 23.5
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #2 180 minutes
- Value:
- 43.8
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #2 240 minutes
- Value:
- 51.4
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #3 60 minutes
- Value:
- 16.3
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #3 120 minutes
- Value:
- 27.3
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #3 180 minutes
- Value:
- 53.6
- Vehicle controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Chamber #3 240 monutes
- Value:
- 73.5
- Vehicle controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Test eye #1
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Test eye #2
- Value:
- > 8
- Vehicle controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Test eye #3
- Value:
- > 8
- Vehicle controls validity:
- valid
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:
- Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) causes severe irritation to eyes.
- Executive summary:
In a rabbit enucleated eye study 0.1 ml of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) 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, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is a severe eye irritant.
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