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Toxicological information

Exposure related observations in humans: other data

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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

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