Octan-2-ol

Skin irritation / corrosion

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

Test material information

Constituent 1

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 EPISKIN^TMreconstituted human epidermis model.