Registration Dossier
Registration Dossier
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EC number: 282-012-8 | CAS number: 84082-67-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Myrtus communis, Myrtaceae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
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:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- Skin irritation was assessed in an acute dermal toxicity study.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Myrtus communis, ext.
- EC Number:
- 282-012-8
- EC Name:
- Myrtus communis, ext.
- Cas Number:
- 84082-67-7
- IUPAC Name:
- Myrtus communis, ext.
- Test material form:
- other: oil
- Details on test material:
- - Name of test material (as cited in study report): Myrte essence
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- None
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 5000 mg/kg bw
- Duration of treatment / exposure:
- No data
- Observation period:
- Skin irritation observed on Day 1
- Number of animals:
- 10
- Details on study design:
- Animals were observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Slight redness (3/10), moderate redness (7/10), slight edema (4/10) and moderate oedema (6/10).
- Other effects:
- One mortality was observed on Day 6.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Dermal reactions noted were slight redness (3/10), moderate redness (7/10), slight edema (4/10) and moderate oedema (6/10) at the site of application.
- Executive summary:
In an acute dermal toxicity study, 10 guinea-pigs were administered a single dermal dose of myrtle essence at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.
Dermal reactions noted were slight redness (3/10), moderate redness (7/10), slight edema (4/10) and moderate oedema (6/10) at the site of application.
One animal was found dead on Day 6.
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