Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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:
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:
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification