Registration Dossier
Registration Dossier
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EC number: 616-968-8 | CAS number: 8015-92-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 - 18 September 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- review article or handbook
- Title:
- Safety Assessment of Anthemis nobilis– Derived Ingredients as Used in Cosmetics
- Author:
- Johnson W, Heldreth B, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW and Andersen FA
- Year:
- 2 017
- Bibliographic source:
- International Journal of Toxicology 36(Supp. 1), 57S-66S.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol published by "Arrété" of 21 September 1984, in the "Journal Officiel de la République Française" of 24 October 1984 and 9 February 1985)
- Principles of method if other than guideline:
- Each test article was applied into the inferior conjunctival sac of rabbits without rinsing. The untreated eye served as a concurrent control. The cornea, iris and cornea were examined 1 hour after instillation of the test article, and then again after 1, 2, 3, 4 and possibly 7 days.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methylpentyl 2-methylisocrotonate
- EC Number:
- 280-815-8
- EC Name:
- 2-methylpentyl 2-methylisocrotonate
- Cas Number:
- 83783-81-7
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 2-methylpentyl 2-methylbut-2-enoate
- Reference substance name:
- 2-methylallyl 2-methylisocrotonate
- EC Number:
- 262-901-7
- EC Name:
- 2-methylallyl 2-methylisocrotonate
- Cas Number:
- 61692-78-2
- Molecular formula:
- C9H14O2
- IUPAC Name:
- 2-methylprop-2-en-1-yl 2-methylbut-2-enoate
- Reference substance name:
- Isobutyl isobutyrate
- EC Number:
- 202-612-5
- EC Name:
- Isobutyl isobutyrate
- Cas Number:
- 97-85-8
- Molecular formula:
- C8H16O2
- IUPAC Name:
- isobutyl 2-methylpropanoate
- Reference substance name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- EC Number:
- 227-705-8
- EC Name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- Cas Number:
- 5947-36-4
- Molecular formula:
- C10H16O
- IUPAC Name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- Reference substance name:
- Pin-2(3)-ene
- EC Number:
- 201-291-9
- EC Name:
- Pin-2(3)-ene
- Cas Number:
- 80-56-8
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Test material form:
- liquid
- Details on test material:
- None given
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Specific details on test material used for the study:
- Ref. 88257.
Lot 682.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Cléon, France).
- Age at study initiation: "Adult"
- Weight at study initiation: 2.35 to 2.70 kg
- Housing: Individually housed in polystyrene cages with perforated flooring (internal dimensions 560 x 355 x 315 mm).
- Diet: Complete pelleted rabbit maintenance diet, about 150 g/animal/day.
- Water: Filtered and softened mains drinking water, ad libitum.
- Acclimation period: 28 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum 19 °C
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hours (07.30 - 19.30)
IN-LIFE DATES: Not specified.
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 20% (v/v) - Duration of treatment / exposure:
- Single instillation only.
- Observation period (in vivo):
- Up to seven days.
- Number of animals or in vitro replicates:
- 6 males.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
SCORING SYSTEM: See table.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits. There was no indication of an irritating effect.
- Executive summary:
The eye irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a study according to French national protocols and compliant with GLP. 0.1 mL of a 20% (v/v) solution of the test material was instilled into the conjunctival sac of the right eye of each of 6 male New Zealand white rabbits, without rinsing. The eyes were examined for effects on the conjunctiva, iris and cornea 1 hour, and 1, 2, 3, 4 and 7 days after instillation of the test item. The mean ocular irritation index was reported to be 0.33 (maximum 110) after 2 days, and 0 after 3 days, corresponding to a non-irritant substance.
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