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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 November 2009 to 09 November 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
EPISKIN(TM) reconstituted human epidermis model.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Octan-2-ol
EC Number:
204-667-0
EC Name:
Octan-2-ol
Cas Number:
123-96-6
Molecular formula:
C8H18O
IUPAC Name:
octan-2-ol
Test material form:
liquid

Test animals

Species:
other: reconstituted human epidermis
Strain:
other: not applicable
Details on test animals or test system and environmental conditions:
Not applicable as the test was performed in vitro.

Test system

Type of coverage:
other: test material applied directly
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
10 µl of the test material was applied to the epidermis surface.
Duration of treatment / exposure:
15 minutes
Observation period:
Not applicable
Number of animals:
The test was conducted In Vitro. Three replicate test tissues were used for the main test.
Details on study design:
TEST SITE
- Area of exposure: Whole of test tissue surface
- % coverage: 100%
- Type of wrap if used: Not applicable


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, each tissue was removed from the well of the treatment plate using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
- Time after start of exposure: 15 ± 0.5 minutes.

SCORING SYSTEM: Not applicable

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: relative mean viability of the test material treated tissues
Value:
87.8
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 15 minutes. Remarks: Score is in % terms. (migrated information)

Any other information on results incl. tables

For the test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:

Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following table:

Criteria for in vitro interpretation

Classification

Mean tissue viability is =50%

Irritant (I) R38

Mean tissue viability is >50%

Non-Irritant (NI)


Mean OD540Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material

Material

OD540of tissues

Mean OD540of triplicate tissues

±SDof OD540

Relative individual tissue viability (%)

Relative mean viability (%)

± SD of % viability

Negative Control Material

0.932

0.879

0.053

106.0

100*

6.0

0.878

99.9

0.826

94.0

Positive Control Material

0.064

0.068

0.030

7.3

7.8

3.4

0.100

11.4

0.041

4.7

Test Material

0.851

0.772

0.088

96.8

87.8

10.0

0.678

77.1

0.788

89.6

 


SD=   Standard deviation

*=     The mean viability of the negative control tissues is set at 100%

The relative mean viability of the test material treated tissues was 87.8% after a 15 minute exposure.

        

The MTT solution containing the test material did not turn blue/purple which indicated that the test material did not directly reduce MTT.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: As specified in the test method.
Conclusions:
The test material was considered to be Non-Irritant.
Executive summary:

The substance has been found to be non-irritating to skin in an in vitro test using the EPISKINTMreconstituted human epidermis model.