Registration Dossier
Registration Dossier
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EC number: 616-221-6 | CAS number: 7541-49-3
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:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-2-en-1-ol
- EC Number:
- 616-221-6
- Cas Number:
- 7541-49-3
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-2-en-1-ol
Constituent 1
- Specific details on test material used for the study:
- 6.1 Test Item
Designation in Test Facility: 20061504G
Date of Receipt: 15. Jun. 2020
Condition at Receipt: Ambient temperature, in proper conditions
6.1.1 Specification
The following information concerning identity and composition of the test item was pro-vided by the sponsor.
Name 3,7,11,15-tetramethyl-2-hexadecen-1-ol
Batch no. PL200101
CAS no. 7541-49-3
Composition 3,7,11,15-tetramethyl-2-hexadecen-1-ol 96.6 %
Storage room temperature (20 ± 5 °C); Nitrogen filled, sealed and stored at room temperature
Expiry date 19. Jan. 2022
Stability stable under storage conditions
Appearance Colorless to light yellow clear oily liquid
Purity 96.6%
Homogeneity homogeneous
Production date 20. Jan. 2020
EC no. 616-221-6
Molecular formula C20H40O
Molecular weight 296.53 g/mol
Vapour pressure not stated
Solubility in solvents H2O: unknown; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated;
Stability in solvents H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
A certificate of analysis was provided by the sponsor and is attached (in copy) in annex 17
6.1.2 Storage in Test Facility
The test item was stored in the fridge (2 - 8 °C), nitrogen filled and sealed from 15. Jun. 2020 - 20. Oct. 2020 and stored in a closed vessel at room temperature (20 ± 5 °C), nitro-gen filled and sealed since 20. Oct. 2020. This deviation was assessed as uncritical by the sponsor.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 1h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Reconstructed human Epidermis (RhE) Test Method following OECD Guideline 439 and EU-Method B.46
- Value:
- ca. 88.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTMwere treated withthe test itemfor 60 minutes (see deviation in chapter11).
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).
DPBS-buffer was used as negative control and 5% SDS solution was used as positive control.
After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.537.
The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 5.4% (required:£20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%).
After the treatment with the test item, the mean value of relative tissue viability was reduced to 88.2%. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.
Therefore, the test item3,7,11,15-tetramethyl-2-hexadecen-1-olis considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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