Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2015-10-19 to 2016-03-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study is performed according to OECD Guideline 405 (2012), and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: JMAFF Guidelines (2000), including the most recent revisions
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Spearmint Essential Oil, ex Mentha spicata
- Physical state: Clear colourless to pale yellow liquid
- Analytical purity: confidental
- Impurities (identity and concentrations): confidental
- Purity test date: confidental
- Lot/batch No.: confidental
- Expiration date of the lot/batch: confidental
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: between 12 and 24 weeks old
- Weight at study initiation: at least 1.5 kg
- Housing: animals were individually housed in labeled cages with perforated floors and shelters.
- Diet (e.g. ad libitum): pellet diet for rabbits (approximately 100 grams per day) and wooden sticks
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24 °C
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item
- Concentration (if solution): n.a.

VEHICLE
The testitem was instilled undiluted, as delivered by the sponsor.
Duration of treatment / exposure:
The animals were treated by instillation of the test item, and subsequently exposed (e.g. the eyes were not washed) to the test item for 72 hours (two test animals) or 7 days (sentinel).
Observation period (in vivo):
The sentinel animal was observed 1 hour after installation, and 24, 48 and 72 hours after (in total for 7 days). 2.5 weeks later the two other animals were observed in a similar way, but for 72 hours in total.
Number of animals or in vitro replicates:
Three in total.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

SCORING SYSTEM:
The numerical scorings recorded were made in compliance with OECD guideline 405 (2012).

TOOL USED TO ASSESS SCORE:
If standard lighting was not considered to be enough, an ophthalmic examination lamp was used to examine the eyes.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: three days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(Redness)
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
All animals showed irritation of the conjunctivae; e.g. all animals showed discharge 1 hour after dosing the test substance. This was not observed after 24 hours for animal 1 and 2, and the discharge effect for the sentinel was reversible after 48 hours. In addition the sentinel suffered from redness for 72 hours. The redness observed for animals 1 and 2 was no longer observed after 24 and 48 hours respectively. All animals suffered from chemosis, but for all three this effect was only observed 1 hour after dosing. Treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage.
Other effects:
There were no signs of systemic toxicity, nor mortality, observed during the test period. The bodyweight of the animals was not reduced. There was no evidence of ocular corrosion.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Based on CLP criteria
Conclusions:
Under the conditions of this test, Spearmint Essential Oil, ex Mentha spicata does not need to be classified as eye irritant, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
Executive summary:

To investigate the potential eye irritating effects of Spearmint Essential Oil, ex Mentha spicata, a study was conducted according to OECD 405. The test item was applied by instillation of 0.1 ml of the testsubstance into one eye of in total three New Zealand White rabbits. The ocular reactions observed included irritation of the conjunctivae (redness, chemosis and discharge). These effects were fully reversible within 4 days, 72 hours or 48 hours. No iridial irritation or corneal opacity were observed. Based on the results of this test it was concluded that Spearmint Essential Oil, ex Mentha spicata does not need to be classified as eye irritant, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).