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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:
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:
1988
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:
2017
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Chemical structure
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
Constituent 4
Chemical structure
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
Constituent 5
Chemical structure
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
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.