3,3'-oxydipropanol

Skin irritation / corrosion

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 guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-oxydipropanol

EC Number:

219-251-4

EC Name:

3,3'-oxydipropanol

Cas Number:

2396-61-4

Molecular formula:

C6H14O3

IUPAC Name:

3-(3-hydroxypropoxy)propan-1-ol

Test material form:

liquid

In vitro test system

Test system:

human skin model

Details on test system:

EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 13. Nov. 2018
Batch no.: 28668

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

30 µl

Duration of treatment / exposure:

1 h

Duration of post-treatment incubation (if applicable):

23.5 h

Number of replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1

Value:

1 433

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2

Value:

1 522

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3

Value:

1 180

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

For the test item and the positive control, the following percentage values of tissue viability were calculated in comparison to the negative control:

Designation	Test-Item	Positive Control
% Tissue viability (tissue 1)	89.8%	2.8%
% Tissue viability (tissue 2)	95.4%	2.4%
% Tissue viability (tissue 3)	74.0%	2.3%
% Tissue viability (mean)	86.4%	2.5%
± SD of mean tissue viability (%)	11.1%	0.3%

Validity criteria and results are stated in the following table:

Criterion	Demanded	Found
Mean OD of negative control	≥0.8 and ≤ 2.8	1.6
Mean % tissue viability of positive control SDS	≤20% of negative control	2.5%
SD of mean viability of the tissue replicates (%)	≤18%	2.9% (negative control) 0.3% (positive control) 11.1% (test item)

 

All validity criteria were met.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean value of relative tissue viability of the test item was reduced to 86.4% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.

Executive summary:

The test item is considered as non-irritant to skin.

After the treatment, the mean value of relative tissue viability was reduced to 86.4%. This value is above the threshold for skin irritation (50%).

The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.

The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.

Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).

For these reasons, the result of the test is considered valid.