Hydrocarbons, C16-C22, n-alkanes, isoalkanes, <2% aromatics

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

21-Jul-2014 to 28-Jul-2014

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C18-C24, iso-alkanes, <2% aromatics

IUPAC Name:

Hydrocarbons, C18-C24, iso-alkanes, <2% aromatics

Constituent 2

Reference substance name:

940-734-7

EC Number:

940-734-7

IUPAC Name:

940-734-7

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Hydrocarbons, C18-C24, isoalkanes, <2% aromatics
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Storage condition of test material: At room temperature in the dark

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µl water

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 10 µl Phosphate buffered saline

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 10 µl
- Concentration (if solution): 5% (aq) Sodium dodecyl sulphate

Duration of treatment / exposure:

Exposure:15 minutes
Post incubation period: 42 hours

Details on study design:

TEST SITE
- Area of exposure: human epidermis model
- % coverage: 0.38 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 15 minutes

POST INCUBATION PERIOD
- 42 hours

SCORING SYSTEM:
- After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: percentage viability

Value:

79

Remarks on result:

other:

Remarks:

Basis: other: percentage of control. Time point: 15 minutes. (migrated information)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In vitro and in vivo skin irritation studies were conducted with Hydrocarbons, C18-C24, isoalkanes, <2% aromatics (GS310) in accordance with OECD test guidelines 439 and 404, respectively, and in compliance with GLP. The in vitro assay did not indicate any skin irritation potential. In the in vivo study, 4-hour dermal exposure to the test substance resulted in very slight erythema in the treated skin areas of the three rabbits which had resolved within 24 hours in two animals and within 72 hours in the other animal. The results of the studies indicated that the substance does not require classification for skin irritation according to the relevant EC and GHS criteria.

Executive summary:

Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Hydrocarbons, C18-C24, isoalkanes, <2% aromatics compared to the negative control tissues was 79%. Since the mean relative tissue viability for the test substance was above 50% after 15 minutes treatment the test substance is considered to be non-irritant.

 

The positive control had a mean cell viability of 21% after 15 minutes exposure. The absolute mean OD₅₇₀(optical density at 570 nm) of the negative control tissues was slightly below laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 7%, indicating that the test system functioned properly.