Registration Dossier
Registration Dossier
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EC number: 283-272-5 | CAS number: 84603-73-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Laurus nobilis, Lauraceae.
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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
- Type of study / information:
- Skin irritation potential of Laurel leaf oil was studied in healthy volunteers.
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- Skin irritation potential of Laurel leaf 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
- Reference substance name:
- Laurus nobilis, ext.
- EC Number:
- 283-272-5
- EC Name:
- Laurus nobilis, ext.
- Cas Number:
- 84603-73-6
- IUPAC Name:
- Laurus nobilis, ext.
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Laurel leaf oil (Laurel leaf Ab.)
- Source: Laurel leaf Ab. - Chauvet, Morocco
Constituent 1
Method
- Details on study design:
- Skin irritation potential of undiluted Laurel leaf oil (Laurel leaf Ab.) was studied in 25 healthy volunteers using epicutaneous test and photo patch tests (UVA and UVB) and dermal reactions were observed.
- Exposure assessment:
- measured
Results and discussion
- Results:
- - Laurel leaf oil (Laurel leaf Ab.): 22/25 subjects showed negative results and 3/25 subjects showed positive results. Phototoxic reactions were also 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 |
|||
Laurel leaf Ab. |
25 |
22 |
3 |
0.12 |
0.08 |
0 |
0.24 |
0.08 |
0 |
0.68 |
Weak phototoxic and irritant |
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, Laurel leaf oil is considered to be weak phototoxic and irritant to skin in healthy volunteers.
- Executive summary:
In a study, undiluted Laurel leaf oil (Laurel leaf Ab.) was studied in 25 healthy volunteers using epicutaneous and photo patch tests (UVA and UVB) and dermal reactions were observed.
22/25 subjects showed negative results and 3/25 subjects showed positive results. Phototoxic reactions were also observed.
Under the test conditions, Laurel leaf oil is considered to be weak phototoxic and irritant to skin in healthy volunteers.
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