Registration Dossier

Administrative data

Description of key information

Basic Blue 99 (CAS no 68123-13-7) does not classify as skinn and eye irritant.  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Reference:
Composition 1
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Dermal irritation capability of basic blue 99 was tested on albino rabbits .
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data
Type of coverage:
other: Patch
Preparation of test site:
other: Shorn intact or abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 g per square inch
Duration of treatment / exposure:
24 Hr
Observation period:
14 day
Number of animals:
3/sex/dose
Details on study design:
TEST SITE- Area of exposure: short intact or abraded skin on the back of animal- % coverage: No data available- Type of wrap if used: patchREMOVAL OF TEST SUBSTANCE- Washing (if done): No data available.- Time after start of exposure: No data available.SCORING SYSTEM: No data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 Hrs
Reversibility:
no data
Remarks on result:
other: No observable skin irritation.
Irritant / corrosive response data:
No data available
Other effects:
No data available
Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Basic Blue 99 is non irritating to the skin of New Zealand White rabbits.
Executive summary:

Dermal irritation study was carried out to test the dermal toxicity of basic blue 99 at the concentration of 0.5g per inch square.Basic Blue 99 (0.5 g per square inch) was applied undiluted to either the shorn intact or abraded skin on the back of animals. The patch was affixed for 24 h. No observable reactions to Basic Blue 99 were noted over the 14-day observation period.According to the CLP classification, the test material Basic Blue 99 does not classify as a skin irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Reference:
Composition 1
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 information:
Composition 1
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
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.
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

In a study conducted by American College of Toxicology (2007), skin irritation was evaluated in New Zealand White male and female rabbit by using Basic Blue 99 in the concentration of 0.5g per inch square. No observable reactions to Basic Blue 99 were noted over the 14-day observation period.

Similar to above reference, skin irritation was evaluated in rabbit by using Basic Blue 99 in the concentration of 0.5g per inch square in distilled water to either the shorn intact or abraded skin on the back of animals. The primary irritation index was calculated to be 0.2 and Basic Blue 99 was considered “mildly irritating” to rabbit skin.

Therefore, on the basis of above available information and according to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as a skin irritant. 

Eye irritation:

In a study conducted by American College of Toxicology (2007), eye irritation was evaluated in New Zealand White rabbit by using Basic Blue 99 in the concentration of 0.5% (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). 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. Therefore, Basic Blue 99 was considered to be non irritating to New Zealand White rabbit eye.

Thus, on the basis of above available information and according to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
No observable reactions to Basic Blue 99 were noted over the 14-day observation period.

Justification for selection of eye irritation endpoint:
Basic Blue 99 was considered to be non irritating to New Zealand White rabbit eye.

Justification for classification or non-classification

On the basis of above available information and according to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as skin and eye irritant.