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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from June 22 to July 27, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well conducted and in compliance with GLP.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: ECVAM protocol version 1.8 of february 2009
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethylocta-1,6-diene
EC Number:
219-433-3
EC Name:
3,7-dimethylocta-1,6-diene
Cas Number:
2436-90-0
Molecular formula:
C10H18
IUPAC Name:
3,7-dimethylocta-1,6-diene
Details on test material:
- Name of test material (as cited in study report): dimethyloctadiene
- Physical state: colourless translucent liquid
- Analytical purity: 91.1 %
- Impurities (identity and concentrations): 1-Isopropenyl-2,3-dimethyl-cyclopentane
- Purity test date: 31 March 2010
- Lot/batch No.: EC205R
- Expiration date of the lot/batch: 18 March 2011
- Storage condition of test material: kept in refrigerator under nitrogen flow, protected from light and humidity

Test animals

Species:
human
Details on test animals or test system and environmental conditions:
Three-dimensional human epidermis model, supplied by SkinEthic Laboratories, Nice, France constituted by:
- a collagen type I matrix, coated with type IV collagen
- a differentiated and stratified epidermis model from human keratinocytes, obtained after 13-day culture period.
All biological components of the epidermis and the kit culture medium have been tested for the absence of viruses, bacteria and mycoplasma

Test system

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 10 µL
Duration of treatment / exposure:
15 ± 0.5 min
Number of animals:
3 epidermis/product
Details on study design:
Before the beginning of the study, the non-specific MTT reduction by the test item was checked by incubating MTT solution and 10 µL test item for 3 hours ± 30 minutes and checking the colour of the solution.

Application of the test item and control:
- negative control: 10 µL of PBS+ to each epidermis surface
- positive control: 10 µL of SDS solution at 5% (w/v) in distilled water; after 7 minutes contact time, an intermediate re-spreading is done
- test substance: 10 µL of the test item, as supplied
- contact timepoint for all products: 15 ± 0.5 minutes at room temperature

Rinsing:
- epidermis rinsed thoroughly with 25 mL of PBS+
- remaining product removed with a cotton-bud

Incubation: plates incubated during 42 ± 1 hours in CO2 incubator with maintenance medium

MTT assay:
- epidermis incubated for 3 hours ± 5 minutes in MTT solution in the CO2 incubator
- formazan extraction in 500 µL of acidic isopropanol stored at 4 hours ± 30 minutes at room temperature, protected from light or during 70 ± 5 hours at 4 °C
- measurement of OD at 570 nm

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: viability % (MTT assay)
Value:
40.9
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 15 min. Reversibility: no data. Remarks: ± 5.2. (migrated information)

In vivo

Irritant / corrosive response data:
No data
Other effects:
No data

Any other information on results incl. tables

Negative control (PBS+): mean OD = 0.821

Positive control (5% SDS): % viability (MTT assay) = 18.7 ± 3.0

Test item: % viability (MTT assay) = 40.9 ± 5.2

Table 1: MTT conversion assay in living epidermis

 

 

OD 1

OD 2

Mean

Standard deviation

Viability %

Mean Viability %

Standard deviation

Negative control

Epidermis 1

0.768

0.808

0.788

0.028

96.0

100

0.044

Epidermis 2

0.855

0.864

0.860

0.006

104.7

Epidermis 3

0.819

0.811

0.815

0.006

99.3

Positive control

Epidermis 1

0.124

0.145

0.135

0.015

16.4

18.7

0.030

Epidermis 2

0.158

0.131

0.145

0.019

17.6

Epidermis 3

0.191

0.172

0.182

0.013

22.1

Test item

Epidermis 1

0.417

0.352

0.385

0.046

46.8

40.9

0.052

Epidermis 2

0.325

0.309

0.317

0.011

38.6

Epidermis 3

0.303

0.309

0.306

0.004

37.3

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, dimethyloctadiene is classified as irritating to the skin in category 2 (H315) according to the CLP Regulation (EC) n° 1272/2008 and as irritating to skin (Xi; R 38) according to the criteria of Annex VI of Directive 67/548/EEC.
Executive summary:

A GLP study conducted in vitro with human epidermis model EPISKIN was performed to assess the irritancy potential of dimethyloctadiene similarly to ECVAM protocol version 1.8 of February 2009.

10 µL of test item was applied directly on epidermis for 15 min on 3 epidermis. Positive control was 10 µL of 5% (w/v) SDS solution and negative control was 10 µL of PBS (each tested on 3 epidermis). MTT conversion assay was peformed to evaluate the percentage of cellular viability of the epidermis.

Positive control had a percentage of viability of 18.7 ± 3.0 and test item 40.9 ± 5.2.

For Dimethyloctadiene, as the percentage of viability was ≤ 50 %, it is considered to be irritating.

Under the test conditions, dimethyloctadiene is classified as irritating to the skin in category 2 (H315) according to the CLP Regulation (EC) n° 1272/2008 and as irritating to skin (Xi; R 38) according to the criteria of Annex VI of Directive 67/548/EEC.