Registration Dossier
Registration Dossier
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EC number: 222-212-4 | CAS number: 3387-41-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- 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
- Test system:
- human skin model
- Source species:
- other: EpiDermTM tissues
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
- Species:
- other: EpiDermTM-Kit
- Type of coverage:
- occlusive
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Number of animals:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- > 50
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Thuj-4(10)-ene is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes
- Species:
- other: Bovine corneas
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 1.34
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Under the conditions of this study, the test item Thuj-4(10)-ene showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 1.34.According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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