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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:
29. 05. – 05. 06. 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Adopted October 2, 2012
Deviations:
yes
Remarks:
(see Any other information ...)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate
EC Number:
274-427-8
EC Name:
Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate
Cas Number:
70210-31-0
Molecular formula:
C43H30N8O14S4.4Na
IUPAC Name:
tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate
impurity 1
Reference substance name:
unknown impurities
IUPAC Name:
unknown impurities
Test material form:
solid: particulate/powder
Details on test material:
Batch No.: 7031/2007Stability/Expiration: Feb 2018Storage: The test substance should be stored in dry room in dark in supplied container at the room temperature.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: breeding farm VELAZ s.r.o., Lysolaje, Czech Republic, RČH CZ 21760118- Weight at study initiation: 2.30 – 2.90 kg- Housing: conventional animal room – individually in metallic cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 5 days, no signs of disease were observedENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 3°C, permanently monitored- Humidity (%): 30 – 70%, permanently monitored- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A dose of 0.1g of the test substance was applied to the test site.
Duration of treatment / exposure:
The test substance was placed into the conjunctival sac of one eye of animals after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the substance. The other eye, which was untreated, serves as a control.The substance was solid and has not been removed from the eye of the test animal by physiological mechanisms at the first observation time point of 1 hour after treatment. The eye was rinsed with physiological saline solution.
Observation period (in vivo):
examined at 1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE - Washing (if done): rinsed with physiological saline solution - Time after start of exposure: 1h SCORING SYSTEM: To the ocular reactions observed at each time interval the grades were assigned according to the grading system given in OECD Test Guideline No. 405 Acute Eye Irritation/Corrosion. Adopted October 2, 2012. TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 13
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 15
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 17
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 13
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 15
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 17
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 13
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal: 15
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: 17
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: 13
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 15
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: 17
Time point:
24/48/72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

No alterations of control eyes were observed during the whole study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The following changes were observed on eye at 1 hour after application: conjunctivae – some blood vessels hyperaemic or diffuse, chemosis – obvious swelling with partial eversion of lids and cornea - coloured by the test substance was observed in all rabbits. Obvious swelling with partial eversion of lids and cornea was observed during 24 hours after application in one rabbit. Coloured cornea persisted to the 2nd day of observation period in two animals. No changes were observed on eye at 72 hour after application in all animals No clinical signs of systemic intoxication were detected.Examination of eye irritation after single application demonstrated, that the test substance, Direct Blue 85, is not irritating to eye of rabbit.
Executive summary:

The test substance, Direct Blue 85, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).

The test was performed according to the OECD Test Guideline No. 405 Acute Eye Irritation/Corrosion. Adopted October 2, 2012.

Before in vivo testing, the sequential testing strategy as it is recommended in supplement to TG 405(2012) was respected.

The test was performed initially using one animal (No. 13). Because no corrosive or severe irritating effects were observed in initial test, the response was confirmed using two additional animals (No. 15 and No. 17).

The following changes were observed on eye at 1 hour after application: conjunctivae – some blood vessels hyperaemic or diffuse, chemosis – obvious swelling with partial eversion of lids and cornea - coloured by the test substance was observed in all rabbits. Obvious swelling with partial eversion of lids was observed during the 24 hours after application in one rabbit. Coloured cornea persisted to the 2nd day of observation period in two animals.

No changes were observed on eye at 72 hour after application in all animals.

No clinical signs of systemic intoxication were detected.

Evaluation of results after single application demonstrated that the test substance, Direct Blue 85, is not irritating to the eye of rabbit.