Registration Dossier

Administrative data

Endpoint:
eye 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 OECD405, report not detailed, no individual data, no recovery period, scoring according to FDA
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 guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no recovery period, scoring according to FDA
Qualifier:
according to
Guideline:
other: FDA Guideline, Federal Register Vol. 37, No. 38, 1972
Principles of method if other than guideline:
-
GLP compliance:
no
Remarks:
study 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: not stated
- physical state: clear colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino-Russian
Details on test animals or tissues 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

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0,1 ml
Duration of treatment / exposure:
Group 1 (5 animals): 5 minutes
Group 2 (3 animals): 24 hours
Observation period (in vivo):
Group 1:
1 hour after washing out of the substance, 24, 48 and 72 hours post application, 7 days (14, 21 days) post application.
Group 2:
1 , 24, 48 and 72 hours post application, 7 days (14, 21 days) post application.
Number of animals or in vitro replicates:
8 rabbits (total of two groups)
Details on study design:
The eyes of the animals of Group 1 were washed out with 300 ml of water 5 minutes post application over a period of two minutes. The eyes were examined 1(+) hour after washing out of the substance, 24(+), 48 and 72 hours post application, 7(+) days (14, 21 days) post application.

The eyes of the animals of Group 2 were washed out with 300 ml of water 24 hours post application over a period of two minutes. The eyes were examined 1, 24(+), 48 and 72(+) hours post application, 7(+) days (14, 21 days) post application.

At the points in time marked with (+) the eyes were also examined after instillation of 0.1 ml of 0.01 % fluorescein solution.

The second eye of each animal was left untreated for comparison purposes.

SCORING SYSTEM:

Pathological findings for cornea, iris and conjunctiva were valuated according their severity:

CORNEA: Scores from 0 to 4

IRIS: Scores from 0 to 2

CONJUNCTIVAE:
A. Redness: Scores from 0 to 3
B. Chemosi s: Scores from 0 to 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all animals of group 1
Time point:
other: 1 h and later
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
other: all animals of group 2
Time point:
other: 1 h and later
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
other: all animals of group 1
Time point:
other: 1 h and later
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
other: all animals of group 2
Time point:
other: 1 h and later
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
other: 3 animals of group 1
Time point:
other: 1 h / 24 h / 48 h / 72 h
Score:
1
Max. score:
3
Reversibility:
other: reversible after 72 hours
Irritation parameter:
conjunctivae score
Basis:
other: 2 animals of group 1
Time point:
other: no data
Score:
2
Max. score:
3
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
other: 1 animal of group 2
Time point:
other: 1 h / 24 h / 48 h / 72 h
Score:
1
Max. score:
3
Reversibility:
other: reversible after 72 hours
Irritation parameter:
conjunctivae score
Basis:
other: 2 animals of group 2
Time point:
other: no data
Score:
2
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
other: 4 animals of group 1
Time point:
other: 1 h / 24 h
Score:
1
Max. score:
4
Reversibility:
other: reversible after 24 hours
Irritation parameter:
chemosis score
Basis:
other: 1 animal of group 1
Time point:
other: 1 h and later
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
other: 2 animals of group 2
Time point:
other: 1 h / 24 h
Score:
1
Max. score:
4
Reversibility:
other: reversible after 24 hours
Irritation parameter:
chemosis score
Basis:
other: 1 animal of group 2
Time point:
other: 1 h and later
Score:
0
Max. score:
4
Irritant / corrosive response data:
-
Other effects:
-

Any other information on results incl. tables

-

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: FDA valuation key acc. Federal Register Vol. 37, No. 38, 1972
Conclusions:
According to the criteria cited in the FDA valuation key acc. Federal Register Vol. 37, No. 38, 1972 triethylene glycol dimethyl ether was classified as slightley irritating to eye. Triethylene glycol dimethyl ether does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC), but has to be classified as irritating (H319- Causes serious eye irritation) according to the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Triethylene glycol dimethyl ether does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC), but has to be classified as irritating (H319- Causes serious eye irritation) according to the EU Classification Labelling and Packaging Regulation (1272/2008/EC).