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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
original German report dated 22 Dec 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to the Fed. Reg. 38, No. 187, § 1500.42, p. 27019 of Sept. 27, 1973.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. 38, No. 187, § 1500.42, p. 27019 of Sept. 27, 1973
Principles of method if other than guideline:
Draize Test
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutaral
EC Number:
203-856-5
EC Name:
Glutaral
Cas Number:
111-30-8
Molecular formula:
C5H8O2
IUPAC Name:
glutaraldehyde
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Glutaraldehyde approx. 50% sol.
- Physical state: liquid
- Analytical purity: 50.0% glutaraldehyde
- Lot/batch No.: the est substance No. was 80/265
- Stability under test conditions: about 12 months

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany (animal breeder)
- Weight at study initiation: 2.62 - 2.99 kg
- Housing: individually, in cages of stainless steel with wire mesh walk floor (floor area was 40 cm x 51 cm), no bedding, sawdust in the waste trays
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf, FRG; ca. 130 g per animal per day
- Water (e.g. ad libitum): about 250 ml per animal per day of fully demineralized water on working days, tap water on week-ends
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye of each test animal served for control.
Amount / concentration applied:
0.1 ml of the test substance was applied into the conjunctival sac of the right eye.
Duration of treatment / exposure:
The test substance was not washed out.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 per sex)
Details on study design:
A volume of 0.1 ml of the unchanged test substance was instilled into the right eye of each of the 6 white Vienna rabbits;.
The test substance was not washed out and the animals were scored for corneal changes, iris effects and conjunctival reaction, after 1, 24, 48 and 72 hours, and after 8 days following test substance application.
The assessment of the findings was based on the scoring system of Draize JH ((Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity, 46-59, 1959).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(for each animal)
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal 1: 2; Animal 2: 2; Animal 3: 2; Animal 4: 2; Animal 5: 2; Animal 6: 2.3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(for each animal)
Time point:
other: 24 h - 48 h - 72 h
Score:
2.15
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Animal 1: 2; Animal 2: 2; Animal 3: 2.3; Animal 4: 2; Animal 5: 2.3; Animal 6: 2.3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(for each animal)
Time point:
other: 24 h - 48 h - 72 h
Score:
2.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal 1: 2; Animal 2: 2.6; Animal 3: 2.3; Animal 4: 2.3; Animal 5: 2.3; Animal 6: 2.3
Irritation parameter:
iris score
Basis:
mean
Remarks:
(for each animal)
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animal 1: 1; Animal 2: 1; Animal 3: 1; Animal 4: 1; Animal 5: 1; Animal 6: 1
Irritant / corrosive response data:
- Reading of the cornea revealed increasing opacity, ranging from scattered or diffuse (24 h) to nearly complete (8 d); the involved area was > 0.75 - <= 1;
- Reading of the iris revealed folds above normal, swelling and circum-corneal injection over the whole observation period, the iris was still reacting to light;
- Reading of the conjunctiva revealed redness (diffuse, deeper crimson red, with individual vessels, which were not easily discernible); swelling (obvious swelling with partial eversion of the lids during the first 48 hours, and swelling with half-closed lids seen until day 8) and eye discharge, which was above normal during the first 48 hours and resulted in moistening of lids and adjacent hairs within the following days (until day 8).
- Additional effects included contraction of pupils, small retractions in the eyelid, suppuration and loss of hair in the margin of the eyelid.
- These effects increased with time and no reversibility could be evidenced.

Any other information on results incl. tables

Summary of the eye scores for each animal at different reading time points, following application of glutaraldehyde:

Reading time point (h: hour; d: day)

Animal

Treated eyes

Conjunctiva

Cornea

Iris

Additional findings

Erythema

Chemosis

Secretion

Opacity

Area

24 h

1

2

2

1

1

4

1

none

2

2

2

1

1

4

1

none

3

2

2

1

1

4

1

pupil contracted

4

2

2

1

1

4

1

pupil contracted

5

2

2

2

1

4

1

none

6

2

2

1

2

4

1

none

48 h

1

2

2

1

2

4

1

none

2

2

3

1

2

4

1

small retractions in eyelid

3

2

2

1

2

4

1

pupil contracted

4

2

2

1

2

4

1

pupil contracted

5

2

2

2

2

4

1

pupil contracted

6

2

2

1

2

4

1

none

72 h

1

2

2

2

3

4

1

suppuration

2

2

3

2

3

4

1

small retractions in eyelid & suppuration

3

3

3

2

3

4

1

suppuration

4

2

3

2

3

4

1

suppuration

5

3

3

2

3

4

1

small retractions in eyelid & suppuration

6

3

3

2

3

4

1

suppuration & small retractions in eyelid

8 d

1

2

2

2

4

4

1*

suppuration & small retractions in eyelid & loss of hair at the margins of the eyelid

2

2

3

2

3

4

1

small retractions in eyelid & suppuration & loss of hair at the margins of the eyelid

3

2

3

3

4

4

1*

small retractions in eyelid & loss of hair at the margins of the eyelid & suppuration

4

2

3

2

4

4

1*

small retractions in eyelid & loss of hair at the margins of the eyelid & suppuration

5

3

3

2

3

4

1

small retractions in eyelid & suppuration & loss of hair at the margins of the eyelid

6

3

3

2

3

4

1

suppuration & small retractions in eyelid & loss of hair at the margins of the eyelid

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria