Rosemary, ext.

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1989

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1989

Materials and methods

Type of study / information:

Skin irritation potential of Rosemary oil was studied in healthy volunteers.

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

Skin irritation potential of Rosemary oil was studied in healthy volunteers using epicutaneous and photo patch tests (UVA and UVB) and dermal reactions were observed.

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

Rosemary, ext.

EC Number:

283-291-9

EC Name:

Rosemary, ext.

Cas Number:

84604-14-8

Molecular formula:

Not applicable for UVCB substance

IUPAC Name:

Essential oil of Rosmarinus officinalis L. (Lamiaceae) obtained from leaves, flowers and twigs by steam distillation

Test material form:

liquid

Method

Details on study design:

Skin irritation potential of undiluted Rosemary oil (Rosemary Ab. and Rosemary CO2 super critical in 25 and 20 healthy volunteers, respectively) was studied using epicutaneous test and photo patch tests (UVA and UVB) and dermal reactions were observed.

Exposure assessment:

measured

Results and discussion

Results:

- Rosemary Ab.: 23/25 subjects showed negative results and 2/25 subjects showed positive results. No phototoxic reactions were observed.
- Rosemary CO2 super critical: 19/20 subjects showed negative results and 1/20 subjects showed positive results. No phototoxic reactions were observed.

Any other information on results incl. tables

Table 7.10.5/1: Irritation and phototoxic effects on healthy volunteers

 

Product	No. of patients tested	Epicutaneous test			Photopatch tests UVA			Photopatch tests UVB			Results
		Negative	Positive	Mean no. of crosses	Identical to epicutaneous test	Increased reaction	phototoxic	Identical to epicutaneous test	Increased reaction	phototoxic
Rosemary Ab.	25	23	2	0.08	0.04	0	0	0.04	0	0	Weak irritant
Rosemary CO2 super critical	20	19	1	0.05	0	0	0	0.05	0	0	Weak irritant

Applicant's summary and conclusion

Conclusions:

Under the test conditions, Rosemary oil is considered to be a weak irritant to skin in healthy volunteers.

Executive summary:

In a study, undiluted Rosemary oil (Rosemary Ab. and Rosemary CO2 super critical in 25 and 20 healthy volunteers, respectively) was studied using epicutaneous and photo patch tests (UVA and UVB) and dermal reactions were observed.

- Rosemary Ab treated groups: 23/25 subjects showed negative results and 2/25 subjects showed positive results. No phototoxic reactions were observed.

- Rosemary CO2 super critical treated groups: 19/20 subjects showed negative results and 1/20 subjects showed positive results. No phototoxic reactions were observed.

 

Under the test conditions, Rosemary oil is considered to be a weak irritant to skin in healthy volunteers