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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride and 3-[(8-amino-dibromo-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride and 3-[(bromo-1,4-dihydroxy-8-imino-5-oxo-5,8-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride
EC Number:
916-466-1
IUPAC Name:
Reaction mass of 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride and 3-[(8-amino-dibromo-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride and 3-[(bromo-1,4-dihydroxy-8-imino-5-oxo-5,8-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride
Test material form:
solid: particulate/powder
Details on test material:
Identification : Basic Blue 99
Batch number : RS27988101
3-[(Bromo-8-amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (main) : 50.2a/a%
3-[(Dibromo-8-amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (E) : 14.6a/a% 3-[(Bromo-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (F) : 16.9a/a%
3-[(Bromo-5,8-dihydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (J) : 4.8a/a% 3-[(8-Amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (A) : 1.0a/a% 3-[(Sulpho-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (B) : 2.0a/a%
3-[(Dibromo-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (G): 2.8a/a%
3-[(Sulpho-8-amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (O) :<0.3a/a%
3-[(Bromo-sulpho-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (N) : 2.1a/a%
Tribromo-8-amino-5-hydroxy-1,4-naphthoquinone (L) : 1.3a/a%
Chloride ion : 14.5%
Sulphate ion : 0.1%
Acetate ion : 0.2%
Zinc ion : 5.5%
Water : 4.1%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
It was suspected that the test item might produce irritancy. Therefore, a single animal (one female) was treated first. As severe irritant effects were observed after the 1 and 24 hour examinations up to 72 hours after treatment, the study was closed without treating the remaining two animals. The animal was treated by instillation of 0.1g of the test substance in the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test item. The right eye remained untreated and served as the reference control. Twenty four hours after treatment, the treated and untreated eyes were rinsed with lukewarm tap water.
Observation period (in vivo):
Approximately 1, 24, 48 and 72 hours after instillation of the test substance.
Number of animals or in vitro replicates:
One
Details on study design:
The ocular reaction was assessed according to the numerical scoring system listed in EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 hours
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 hours
Score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72 hours
Score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean value after 24, 48 and 72 hours
Score:
3
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 hours
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 48 hours
Score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 72 hours
Score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean value after 24, 48 and 72 hours
Score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 1 hour
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24 hours
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 48 hours
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 72 hours
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: mean value after 24, 48 and 72 hours
Remarks on result:
other: Not assessable due to staining produced by the test item
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 hours
Score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 48 hours
Score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 72 hours
Score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean value after 24, 48 and 72 hours
Score:
3.67

Applicant's summary and conclusion

Interpretation of results:
other: Eye Damage 1 (H318 : Causes serious eye damage)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria (Commission Directive 2001/59/EC), the test item is considered to be classified as R41 - risk of serious damage to eyes. The test item is classified as Eye Damage 1 - causes serious eye damage under EU Regulation 1272/2008.
Executive summary:

The primary eye irritation potential of Basic Blue 99 was investigated according to OECD guideline 405. The test item was applied by instillation of 0.1g into the left eye of a young adult New Zealand White rabbit. Twenty four hours after treatment, the treated and untreated eye were rinsed with lukewarm tap water. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for the animal for corneal opacity, iris, redness and chemosis of the conjunctivae in so far as numerical scores were assessable. The individual mean score for corneal opacity was 3.0 and for the iris the maximum score of 2.0. The reddening of the conjunctivae was not assessable throughout the observation period and the individual mean score for chemosis was 3.7. The instillation of Basic Blue 99 into the eye of one animal resulted in severe and early onset ocular changes, discharge and chemosis. The assessment of the redness of the conjunctivae and sclera was not possible throughout the observation period due to staining produced by the test item. The assessment of the cornea and iris was also not possible 1 and 24 hours after treatment due to staining produced by the test item. Marked opacity, affecting the whole area, was noted in the eye at the 48 and 72 hour reading as well as an absent light reflex. Marked black to blue staining of the treated eye by the test item was evident from the 1 hour reading up to 72 hours after treatment. No clinical signs were observed. It was agreed to close the study with one treated animal after the 72 hour reading. Based upon the referred classification criteria (Commission Directive 2001/59/EC), the test item is considered to be classified as R41 - risk of serious damage to eyes. The test item is classified as Eye Damage 1 - causes serious eye damage under EU Regulation 1272/2008.