Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methods applied similar to OECD404, report not detailed, no individual data
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24h exposure instead of 4 h
Principles of method if other than guideline:
-
GLP compliance:
no
Remarks:
performed before GLP guidelines

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triglykoldimethylether
- Analytical purity: > 99%
- physical state: clear colourless liquid

Test animals

Species:
rabbit
Strain:
other: Albino-Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG own breed
- Strain: Albino Russian rabbits
- Weight at study initiation: 1,5-2,0 kg
- Age at study initiation: no data
- Diet: ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water ad libitum
- Acclimatization period: no data

ENVIRONMENTAL CONDITIONS
- Housing: single cages

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0,5 ml of pure substance was applied.
Duration of treatment / exposure:
24 hours
Observation period:
24 hours post application
48 hours post application
72 hours post application
Number of animals:
6 rabbits
Details on study design:
TEST SITE:

- Shaved area: two neighboured positions, each 3 x 3 cm
- Preparation of skin area: one position only shaved, the other one abraded in addition.
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The substance was applied over the whole surface of a 2.5 x 2.5 cm gauze patch. The patches were fixed with adhesive tape to the prepared skinarea (ca. 2 x 9 cm2) and then covered with an occlusive PVC foil and further fixed with an elastic bandage.

SCORING SYSTEM:

According to guideline "Code of Federal Regulations, Title 21, Chapter 1, § 191.11, S. 243-244, 1972"

The classification was cunducted according to following evaluation classes:

< 2.................mildly irritant
2-5.................moderately irritant
> 6.................severely irritant

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: all animals
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Remarks on result:
other: no irritation in all animals
Irritant / corrosive response data:
-
Other effects:
-

Any other information on results incl. tables

-

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance triethylene glycol dimethyl ether can be considered as non irritating to skin under the conditions of this Patch-test and according to criteria cited in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and the Code of Federal Regulations, Title 21, Chapter 1, § 191.11, S. 243-244, 1972.
Executive summary:

The test substance triethylene glycol dimethyl ether can be considered as non irritating to skin under the conditions of this Patch-test and according to criteria cited in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and the Code of Federal Regulations, Title 21, Chapter 1, § 191.11, S. 243-244, 1972.