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Toxicological information

Skin irritation / corrosion

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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:
2018

Materials and methods

Test guidelineopen allclose all
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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

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.