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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
0.1 ml of a 38% aqueous solution were applied. This correspons to 38 mg. For the solid with a bulk density of 500 kg/m3, 0.1 ml would have been 50 mg. Dosed amount slightly lower than required by guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only observed until day 8, however all findings had resolved.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
EC Number:
223-339-8
EC Name:
Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
Cas Number:
3844-45-9
Molecular formula:
C37 H34 N2 Na2 O9 S3
IUPAC Name:
disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)benzenesulfonate
Constituent 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Test material form:
liquid
Details on test material:
aqueous solution with salts
Specific details on test material used for the study:
38% aqueous formulation
(contains 47% water, 7% oxalic acid and other salts)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Mean body weights: males 3.0 kg, female 2.91 kg
One animal per cage (type: stainless steel, 40 x 51 cm); animal identification via ear tattoo.
The animals were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
A standardized animal laboratory diet (about 130 g/animal/day) and tap water (about 250 ml/animal/day) were offered.
Acclimatization period: at least 8 days before study start (same housing conditions as during the study).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml (corresponds to 38 mg)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
3
Details on study design:
Instillation into the conjunctival sac of the right eye.
Assessment: according to OECD and Draize
Readings: 1 h, 24 h, 48 h, 72 h and 8 day after instillation
Body weight determined on day 0 and day 8
Eyes were examined with fluorescein on day 8.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all three animals
Time point:
other: 1h
Remarks on result:
not determinable
Remarks:
The substance is a blue dye, scoring was not possible.
Irritation parameter:
cornea opacity score
Basis:
other: all three animals
Time point:
24 h
Remarks on result:
not determinable
Remarks:
The substance is a blue dye, scoring was not possible.
Irritation parameter:
cornea opacity score
Basis:
other: all three animals
Time point:
other: 48h, 72h, 8 days
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Remarks on result:
not determinable
Remarks:
The substance is a blue dye, scoring was not possible.
Irritation parameter:
chemosis score
Basis:
other: all three animals
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 - 72 h
Score:
0.16
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
other: all three animals
Time point:
other: 1h
Remarks on result:
not determinable
Remarks:
The substance is a blue dye, scoring was not possible.
Irritation parameter:
iris score
Basis:
other: all three animals
Time point:
24 h
Remarks on result:
not determinable
Remarks:
The substance is a blue dye, scoring was not possible.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not determinable
Remarks:
The substance is a blue dye, scoring was not possible.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not determinable
Remarks:
The substance is a blue dye, scoring was not possible.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
other: all three animals
Time point:
other: 72h, 8 days
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Due to transient blue coloring of the eye (for two days in two animals and for one day in one animal), not all values could exactly be determined. The substance is a blue dye.

With the above mentioned restrictions on scoring, no adverse effects were noted on iris and cornea. Swelling of conjunctivae resolved in two animls within 2 days and in one animal within 3 days. Redness of conjunctivae resolved in two animals within 3 days and in one animal within 8 days.
Other effects:
Body weights remained unchanged during treatment
Animal 1: 2.91 / 2.94 kg (day 0 / day 0)
Animal 2: 3.15 / 3.15 kg (day 0 / day 0)
Animal 3: 2.94 / 2.99 kg (day 0 / day 0)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An aqueuous formulation containing 38% of the substance is not irritating to eyes.