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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Basic Blue 99
Author:
American College of Toxicology
Year:
2007
Bibliographic source:
International Journal of Toxicology, 26(Suppl. 2):51–63, 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Eye irritation study was performed on New Zealand rabbits to evaluate the irritant nature of the test compound Basic Blue 99
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Basic Blue 99- Molecular formula (if other than submission substance):C19-H20-Br-N4-O2.Cl- Molecular weight (if other than submission substance):451.75 g/mol- Substance type:Organic- Physical state:SolidPurityAccording to the Keystone Aniline Corporation (1999) the chemical is atleast 63% pure Another supplier of Basic Blue 99 (Henkel 1992) has a specification of 60.7% dye content- Impurities (identity and concentrations):According to the Keystone Aniline Corporation (1999) have no more than 100 ppm of ironAnother supplier of Basic Blue 99 (Henkel 1992) suggests the presence of 25.7% sugar content, 11.8% inorganic salts, and 1.8 % volatile matter/water crystallization.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Details on test animalTEST ANIMALS- Source:- Age at study initiation: No data available- Weight at study initiation: No data available- Fasting period before study: No data available- Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available

Test system

Vehicle:
other: Saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5% Basic Blue 99 (0.1 ml)
Duration of treatment / exposure:
No data available
Observation period (in vivo):
30 and 60 min and 1 and 2 days post instillation
Number of animals or in vitro replicates:
Three
Details on study design:
TEST SITE- Area of exposure: The conjunctional sac of the left eye- % coverage: No data available- Type of wrap if used: No data availableREMOVAL OF TEST SUBSTANCE- Washing (if done): No data available- Time after start of exposure: No data availableSCORING SYSTEM: Corneal and iris parameters were observed.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 30min and 60min and 1 and 2 days post instillation
Reversibility:
not specified
Remarks on result:
other: The conjunctivae of the Basic Blue 99 treated eye were discolored, but no effects on the cornea or iris were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The test material Basic Blue 99 is non irritating to the eyes of rabbits.
Executive summary:

Eye irritation study was performed on New Zealand rabbits to evaluate the irritant nature of the test compound Basic Blue 99

A solution of 0.5% Basic Blue 99 (0.1 ml) was instilled into the conjunctinal sac of the left eye and the right eye received 0.1 ml of vehicle alone (saline). Eye irritation was read at 30 and 60 min and 1 and 2 days post instillation. The conjunctivae of the Basic Blue 99 treated eye were discolored, but no effects on the cornea or iris were observed in any animal. The study concluded that the mucous membrane injury threshold concentration for the rabbit eye is greater than 0.5% Basic Blue 99.

According to the publication, the test material Basic Blue 99 does not classify as an eye irritant.