Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No in vitro skin or eye irritation studies are available or required.

 

The skin irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a in vivo study conducted 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 (Clement, 1988).

 

The eye irritating potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in rabbits in a in vivo 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 (Clement, 1988).

 

No relevant respiratory tract irritation data were identified.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
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. QA statement)
Specific details on test material used for the study:
Ref. 88257.
Lot 682.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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.
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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)
Specific details on test material used for the study:
Ref. 88257.
Lot 682.
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.
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In addition to the key skin irritation study (Clement, 1988) described above, two earlier skin irritation studies are briefly described in the peer-reviewed literature (Opdyke, 1974). In the first, Roman chamomile oil was applied undiluted to the intact and abraded skin of rabbits for 24 hours, under occlusion. The substance was found to be moderately irritating [with, presumably, a higher degree of irritation seen at abraded sites, although this is not specified in the citing source] (Moreno, 1973). In the other, Roman chamomile oil was applied undiluted to the skin of hairless mice. The substance was found to be non irritating (Urbach and Forbes, 1973). [No further details provided in citing source.]

 

The skin irritation potential to humans was evaluated in several studies described by the Cosmetic Ingredient Review (CIR) Expert Panel (Johnson et al., 2017). Skin irritation was not observed when Anthemis nobilis “flower oil” (4% in petrolatum) was assessed in a 48-hour closed patch test involving [an unspecified number of] individuals. In repeated insult patch tests in humans (HRIPTs), Anthemis nobilis essential oil [concentration unspecified] did not induce skin irritation in 104 and 110 patients. A skin care lotion containing 3% Anthemis nobilis “flower oil” was also tested in a HRIPT and found not to have a potential for eliciting dermal irritation.

 

No respiratory tract irritation data were identified. A new study was not conducted as it is not a REACH Standard Information Requirement.

Justification for classification or non-classification

Based on the results of the available laboratory animal in vivo skin and irritation studies (Clement, 1988), and supporting human evidence, Anthemis nobilis, ext., (Chamomile oil) does not require classification as a skin or eye irritant according to EU CLP criteria (EC 1272/2008).