Mentha arvensis, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

1974

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Read across from peppermint oil. The documentation is a summary of methods and results, individual scores are not included.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In an eye irritation test following the method of Draize, 0.1 ml of 10, 20, 30, 40, 50, or 60% test substance in olive oil was applied to the right eye (conjunctival sac) of rabbits (8 animals/dose group). The upper and lower lids were held closed for one minute. Afterwards, the eyes of 4 animals were rinsed for 1 minute with physiological saline and those of the remaining 4 were not rinsed. The test substance mixture was warmed at the 3 highest concentrations to keep the mixture fluid.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Brazilian menthol (peppermint oil)

IUPAC Name:

Brazilian menthol (peppermint oil)

Constituent 2

Reference substance name:

Peppermint oil

IUPAC Name:

Peppermint oil

Details on test material:

- Name of test material (as cited in study report): Brazilian menthol (peppermint oil)
- Physical state: Liquid
- Analytical purity: No data
- Lot/batch No.: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data on test animals and environmental conditions.

Test system

Vehicle:

other: Olive oil

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 10, 20, 30, 40, 50, and 60%

Duration of treatment / exposure:

1 minute and 24 hours

Observation period (in vivo):

24 hours

Number of animals or in vitro replicates:

48 (8/dose group)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): In each dose group the eyes of 4 animals were rinsed for 1 minute with physiological saline, and those of the remaining 4 were not rinsed.
- Time after start of exposure: 1 minute

SCORING SYSTEM: No data

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Results

Remarks on result:

other: no effects observed in all concentrations, no individual scores provided

Irritant / corrosive response data:

At 10, 20, 30, 40, 50, or 60% no effects and no reactions were observed.

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

At 10, 20, 30, 40, 50, and 60% no effects and no reactions were observed. Under the conditions of this study, 10 to 60% test substance in olive oil was not an eye irritant in rabbits.

Executive summary:

In an eye irritation test following the method of Draize, 0.1 ml of 10, 20, 30, 40, 50, or 60% test substance, Brazilian menthol (peppermint oil), diluted in olive oil, was applied to the right eye (conjunctival sac) of rabbits (8 animals/dose group). The upper and lower lids were held closed for one minute. Afterwards, the eyes of 4 animals were rinsed for 1 minute with physiological saline and those of the remaining 4 were not rinsed. The test substance mixture was warmed at the 3 highest concentrations to keep the mixture fluid. At 10, 20, 30, 40, 50, or 60% no effects and no reactions were observed. Under the conditions of this study, 10 to 60% Brazilian menthol (peppermint oil) in olive oil was not an eye irritant in rabbits. The documentation is a summary of methods and results, individual scores are not included. Therefore, no conclusion on classification in accordance with 67/548/EEC and 1272/2008/EC can be drawn.