Eucalyptus maculata citriodora, ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Maximization test (modified after JID 47:393-409):
- Principle of test: To determine the skin sensitizing and skin irriating potential of eucalyptys citriodora
- Short description of test conditions: Forty five healthy inmate volunteers were screened and 32 completed the study.
- Parameters analysed / observed: Skin sensitization and skin irritation.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Eucalyptus citrodora

IUPAC Name:

Eucalyptus citrodora

Details on test material:

- Name of test material (as cited in study report): Eucalyptus citriodora
- Physical state: Liquid
- Analytical purity: Confidential information
- Lot/batch No.: Confidential information
- Expiration date of the lot/batch: Confidential information
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

other: human

Strain:

other: not applicable

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Pretreatment with Sodium Lauryl sulfate (SLS)

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Not specified

Duration of treatment / exposure:

48 hours

Observation period:

72 hours

Number of animals:

32 humans

Details on study design:

TEST SITE
- Area of exposure: Volar aspects of the forearm
- Type of wrap if used: Occlusion

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified

OBSERVATION TIME POINTS
- 48h and 72h after exposure

SCORING SYSTEM:
-Assumed according to 'Magnusson and Kligman grading scale for the evaluation of challenge patch test reactions' or similar scoring system.

OTHER
-Materials were pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required; all subjects were pretreated with 5% SLS (patch sites were pretreated for 24 hours). The materials were applied under occlusion on the volar aspects of the forearm for 5 alternate day 48 hour periods. After a 10 -14 day resting period, challenge patches were applied under occlusion to fresh sites for 48 hours. (Challenge application were preceded by 30 -minute applications of 5% SDS, and without SLS on the right side.)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: human

Time point:

other: observation period after challenge

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No reactions were considered significantly irritant or allergic in the subjects tested.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria

Conclusions:

Under the conditions of this study, the testing material gave no reactions that were considered significantly irritant or allergic. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in the CLP Regulation (1272/2008/EC).

Executive summary:

The sensitizing and irritation potential of Eucalyptus Citrodora on humans was tested in a maximization procedure. Materials were pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required; all subjects were pretreated with 5% SLS (patch sites were pretreated for 24 hours). The materials were applied under occlusion on the volar aspects of the forearm for 5 alternate day 48 hour periods. After a 10 -14 day resting period, challenge patches were applied under occlusion to fresh sites for 48 hours. (Challenge application were preceded by 30 -minute applications of 5% SDS, and without SLS on the right side.) Under the conditions of this study, the testing material gave no reactions that were considered significantly irritant or allergic. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in the CLP Regulation (1272/2008/EC).