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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
13 to 15 January 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study undertaken at GLP accredited laboratory to internationally accepted guidelines but performed with DEGDME a substance used for read across. DEGDME is like DEGDEE part of the diethylene glycol monoalkyl and dialkyl ethers category. These substances have been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile (see Category Approach-Read across Diethylene Glycol Diethyl Ether, 2013). Therefore, a read-across from DEGDEE to data obtained with DEGDME is scientifically justified.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline In Vitro Skin Irritation: Human Reconstructed Epidermis (RhE) Test Method, Version 4, 11 December 2009
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Diethylene glycol methyl ethyl ether
- Physical state: Colourless liquid
- Analytical purity: > 99.8% (w/w)
- Impurities (identity and concentrations):
- Purity test date: 12 November 2009
- Lot/batch No.: DEG4055316
- Expiration date of the lot/batch: 02 December 2010

Test animals

Species:
human
Details on test animals and environmental conditions:
Human Epidermis
- Source: SkinEthic, 45 rue Saint Philippe-Le Palmeira, 06000 Nizza, France
- Age at study initiation: Foreskin Age 4 years

Test system

Type of coverage:
open
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume): 20 µl

Duration of treatment / exposure:
Quality control; 4h (±15min)
Positive control; 42 min (± 1 min)
Negative control; 42 min (± 1 min)
Test substance; 42 min (± 1 min)
Details on study design:
Supplier: SkinEthic, 45 rue Saint Philippe-Le Palmeira, 06000 Nizza, France
Lot No.: 09 022A 1211
Origin: Foreskin Age 4 years
Expiration date: 2010-01·18: day 24 of airlifted culture
Supplier's quality controls: Cell viability at day 17 (MTT test, n=2):
Specification: OD > 0.7 Result: OD = 1.287 ± 0.164
Validity references: Statement on the scientific validity of in-vitro tests for skin irritation testing. Endorsement from the Commission members of the ECVAM Scientific Advisory Committee (ESAC). 29th meeting; 4-5th November, 2008 at the European Commission in Brussels

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
1.966
Remarks on result:
other:
Remarks:
Basis: mean (Negative control). Time point: 42h. Remarks: Viability (mean) 100%. (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.029
Remarks on result:
other:
Remarks:
Basis: mean (postive control). Time point: 42h. Remarks: Viability (mean) 1.5%. (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.373
Remarks on result:
other:
Remarks:
Basis: mean (Diethyleneglycol EM). Time point: 42h. Remarks: Viability (mean) 19.0%. (migrated information)

Any other information on results incl. tables

After topical application of the test substance Diethylenglycol EM had an unpredictable macroscopic interactions of the test substance diethylenglycol ethyl methyl ether with the inner surface of the cell culture insert. To our present knowledge it remains unclear, if the observed interactions may also have affected the test performance and the corresponding test result.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this in vitro skin irritation study, Diethylenglycol methyl ethyl ether is predicted as a category 2 skin irritant.
Executive summary:

DEGDEE and DEGMEE, which is in the above study tested for its skin irritation, are both part of the diethylene glycol monoalkyl and dialkyl ethers category described and evaluated in the document titled "Category Approach-Read across Bis(2 -ethoxyethyl)ether" (2013).

These substances have been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile . Therefore, a read-across from DEGDEE to data obtained with DEGMEE is scientifically justified.