Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methods applied similar to OECD405, report not detailed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: FDA Guideline, Register 38 No. 187, 27.09.1973, p 27019
GLP compliance:
no
Remarks:
study performed before GLP guidelines

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethylenglykol-dimethylether
- Analytical purity: not stated
- physical state: clear colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG own breed
- Strain: Albino Himalayan, Hoe:HIMK(SPFWiga)
- 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:
24 hours
Observation period (in vivo):
1 hour post application
7 hours post application
24 hours post application
48 hours post application
72 hours post application
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
The eyes were examined 1, 7, 24, 48 and 72 hours after application of the test substance.
24 hours after treatment the eyes were washed out with physological saline.
At 48 and 72 hours the eyes were also examined after instillation of one drop of 0.01 % fluorescein-sodium solution.

SCORING SYSTEM:

A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4

B. Affected area
1 = punctiform up to 1/4 but not 0
2 = more than 1/4 up to 1/2
3 = more than 1/2 up to 3/4
4 = more than 3/4 up t o 4/4

a = A x B x 5 (max 80)

IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2

b = Value x 5 (max. 10)

CONJUNCTIVAE

A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3

B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4

C. Secretion
No secretion......................................................................................................................0
Any secretion above normal...........................................................................................1
Secretion with wetting of palpebra and hair close to palpebra.................................2
Secretion with wetting of palpebra, hair and considerable area around eyes........3

c = (A+B+C) x 2 (max. 20)

For each animal the ratings for cornea (a), iris (b) and conjunctivae (c) were added for the respective time of observation. For each time of observation the mean value was calculated for all animals. The highest determined irritation score for any time of observation was used for classification according following evaluation classes:

0-10..........non irritant
11-25.......slightly irritant
26-56.......moderately irritant
57-110.....severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 hours
Score:
13
Max. score:
110
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72h
Score:
0.78
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72h
Score:
0.28
Max. score:
4
Reversibility:
not fully reversible within: 48h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
With reference the reported scores and the reversibility of the observed effects Dithylene 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) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Diethylene glycol dimethyl ether was tested for its eye irritant properties in 6 New Zealand White rabbits.The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs were fully reversible within 72h.

With reference the reported scores and the reversibility of the observed effects Diethylene 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) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).