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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:
October 4, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulpho-2-naphthyl)azo]-7-sulpho-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulpho-2-naphthyl)azo]-6-sulpho-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate
EC Number:
911-640-3
Molecular formula:
C40H27N7O13S4.4Na
IUPAC Name:
Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulpho-2-naphthyl)azo]-7-sulpho-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulpho-2-naphthyl)azo]-6-sulpho-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate
Details on test material:
SMILE notation for Vapour pressure
O=S(=O)(O[Na])c8cccc1c8cc(cc1S(=O)(=O)O[Na])/N=N/c7ccc(/N=N/c5ccc(/N=N/c2c(O)c3ccc(N)cc3cc2S(=O)(=O)O[Na])c4cc(ccc45)S(=O)(=O)O[Na])c6ccccc67

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippischen Versuchstierzucht
- Weight at study initiation: 2,4 kg
- Housing: animals were kept in individual cages
- Diet (e.g. ad libitum): ad libitum "mümmel z"
- Acclimation period: 7d.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity : 40% RH
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Test system

Vehicle:
water
Controls:
other: untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 100 µl bulk volume of the amorphous substance

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
The substance was injected into the conjunctival sac of the lower eyelid of the right eye. The lids were then gently held together for 1 sec.
Observation period (in vivo):
From 1 hour to 8 days.
Number of animals or in vitro replicates:
3
Details on study design:
- The eye findings were 1 h, then 24, 48 and 72 h and 8 d after exposure.

TOOL USED TO ASSESS SCORE: The corneal findings was after the 24-hour observation with the fluorine-esceintest hedged (instillation of 1 drop of fluorescein solution in ophthalmic preparation directly on the cornea). The assessment was performed using an ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
other: not appliccale
Remarks on result:
not determinable
Remarks:
substance-related staining of the conjunctival
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
3
Reversibility:
fully reversible

Any other information on results incl. tables

The eye findings were 1 h, then 24, 48 and 72 h and collected 8 d after exposure. Evaluated pathological findings in the cornea (after turbidity degree and area) were, iris and conjunctiva (for redness, swelling and discharge).The degrees of damage after 24, 48 and 72 h on (1) cornea (O - 80), (2) iris (O - 10) and (3) the conjunctiva (O - 20), together O - 110 applied on 3 experimental animals.

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for eye irritation following OECD 405. Under the experimental conditions it did not show any irritation potential to the eye.
Executive summary:

The substance was tested following OECD 405 for eye irritation. Three New Zeland rabbits were injected with the sample in water and checked regularly. None of the animals showed a score (chemosis, redness and discharge of the conjunctiva, iris and corneal opacity) higher than 1 and the effects were fully reversible within the period of observation.