Registration Dossier
Registration Dossier
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EC number: 204-811-2 | CAS number: 126-91-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (R)-3,7-dimethyl-1,6-octadien-3-ol
- EC Number:
- 204-811-2
- EC Name:
- (R)-3,7-dimethyl-1,6-octadien-3-ol
- Cas Number:
- 126-91-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- (3R)-3,7-dimethylocta-1,6-dien-3-ol
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Source strain:
- not specified
- Vehicle:
- not specified
- Details on test system:
- The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 60 minutes.
- Duration of post-treatment incubation (if applicable):
- 23 hours and 25 minutes
- Number of replicates:
- Three tissues
Test animals
- Species:
- other: human
- Strain:
- not specified
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 60 minutes.
- Number of animals:
- Three tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 2.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item (R)-3,7-dimethyl-1,6-octadien-3-ol is considered as irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 2.4%. This value is below the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability crite-rion of 0.8 ≤ mean OD ≤ 2.8.
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