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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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
Remarks:
and to GLP

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:
other: Protocol published by "Arrété" of 1 February 1982, in the "Journal Officiel de la République Française" of 21 February 1982
Principles of method if other than guideline:
Each test article was applied to intact and scarified skin of rabbits, for 24 hours under occlusive coverage. Macroscopic examinations were carried out 30 minutes after removal of the patch and again 48 hours (i.e. 24 and 72 after application).
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Roucher/Bancel (France).
- Age at study initiation: "Adult"
- Weight at study initiation: 2.30 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: minimum 7 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

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
Abraded skin also evaluated in this study.
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 20% (v/v)
Duration of treatment / exposure:
24 hours.
Observation period:
72 hours (final scoring of skin reactions was 72 hours after test item application)
Number of animals:
6 males.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.29
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
8
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
Observations only made at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observations only made at 24 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits. There was no indication of an irritating effect.
Executive summary:

The skin irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a study according to French national protocols and compliant with GLP. 0.5 mL of a 20% (v/v) solution of the test material was applied to the clipped skin of 6 male New Zealand white rabbits, for 24 hours under occlusive coverage. Application sites were scored for erythema and oedema 30 minutes and 48 hours after removal of the occlusive capsule (i.e. 24 and 72 hours after application of the test item). The primary cutaneous irritation index was reported to be 0.29 (maximum 8), corresponding to a non-irritant substance.