3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Qualifier:

equivalent or similar to guideline

Guideline:

other: as below

Principles of method if other than guideline:

In vivo Skin Prick-Test of Basic Blue 99 in women

GLP compliance:

not specified

Type of study:

skin painting test

Species:

human

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS- Source: No data available - Age at study initiation: 57-year-old - Weight at study initiation: 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

Route:

epicutaneous, open

Vehicle:

no data

Concentration / amount:

1% aq.

Concentration / amount:

1% aq.

No. of animals per dose:

1

Details on study design:

No data available

Challenge controls:

Histamine and physiological serum

Positive control substance(s):

yes

Remarks:

p-toluenediamine (cross-reacts with PPD), methyldibromo glutaronitrile (actual relevance not known), and several extracts of so-called ‘hypoallergenic leather’

Positive control results:

Positive

Reading:

1st reading

Dose level:

1 %

No. with + reactions:

3

Clinical observations:

Strong reactions were observed

Remarks on result:

other: Reading: 1st reading. Dose level: 1 % . No with. + reactions: 3.0. Clinical observations: Strong reactions were observed .

Interpretation of results:

sensitising

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Basic Blue 99 was considered to be Sensitizing when tested by prick test in woman

Executive summary:

In a in vivo prick test, 57-year-old woman were tested with 1 % Basic Blue 99. Strong reactions (+++, >histamine) were observed within 15 min of test. The same test was repeated after two months which give same results. In addition, Immediate positive reactions were observed in woman tested by using diluted TLC strips and concentrated TLC strip. Therefore, Basic Blue 99 was considered to beSensitizing when tested by prick test in woman.

 

According to the publication, the test material classifies as a skin sensitizer.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

In a case study conducted by Katrienet. al.(2014), in vivo skin sensitization was evaluated in 57-year-old woman by using Basic Blue 99 in the concentration of 1 %. Strong reactions (+++, >histamine) were observed within 15 min of test. The same test was repeated after two months which give same results. In addition, immediate positive reactions were observed in woman tested by using diluted TLC strips and concentrated TLC strip. Therefore, Basic Blue 99 was considered to be Sensitizing when tested by prick test in woman. According to the publication, the test material classifies as a skin sensitizer.

In a study report given by American College of Toxicology (2007), in vivo LLNA test was carried out to test the sensitizing potential of basic blue 99 on CBAJ mice applied in the concentration of 0.25%, 0.50%, 1.0%, or 2.0%. Basic Blue 99 at 0.5%, 1.0% and 2.0% gave statistically significantly greater responses than the vehicle control, but not test/control ratios greater than 3. A positive response was also observed in the 0.25% group, but the difference was not statistically significant as compared to the vehicle control. Basic Blue 99 may induce a hypersensitivity response According to the publication, the test material classifies as a skin sensitizer.

In a case report given by American College of Toxicology (2007), 71-year-old woman experienced severe itching of the scalp 3 days after application of a hair-setting lotion containing a hair dye. Wheals developed on her trunk and limbs and disappeared after 1 week. After a second application of the lotion, the patient had itching of the scalp and widespread urticaria, which cleared over several weeks (suppressed by an oral antihistamine). Patch tests were performed again and several wheals were present on skin treated with 1% aqueous Basic Blue 99 and the hair-setting lotion hair dye. Scratch tests were performed and reading after 20 min showed +2 reactions to the hair-lotion dye and 1% aqueous Basic Blue 99. Due to systemic absorption of Basic Blue 99 widespread urticarial were suggested. Therefore, Basic Blue 99 is sensitizing to the skin of 71 yr old woman.

In a case report conducted by Wigger-Albertiet. al.(1996), in vivo skin prick test was performed on 67-year-old man by using Basic Blue 99. Strong immediate-type reaction (+ + + + +) were observed in 15 min of test as compared to control. Therefore, Basic Blue 99 was considered to be Sensitizing when tested by skin prick test in man.

In a case report conducted by Antonet. al.(1990), 46-year-old woman had applied a colored foam product weekly for 6 months without any side effects, but that 8 h after applying a liquid version of the product unintentionally to the scalp, the patient noticed burning and itching of the scalp and forehead, with redness and swelling of the forehead and upper eyelids. An exudative eruption on the scalp was seen. After 4 days, the patient had significant temporary hair loss from the allergic reaction. She was first treated 7 weeks post exposure and had thinner hair with localized seborrhoeic-like dermatitis. An open test with the product in the elbow fissure resulted in papular dermatitis after 2 days. A positive reaction was noted to 1% Basic Blue 99 in petrolatum. Seven months later the patient was patch tested using Basic Blue 99 at concentrations 0.1% and 1% in water and petrolatum. 0.1% pet. -/+; 1% pet. ?+/++; 0.1% aq. ? +/+++; 1% aq. ? +/+++. Therefore, Basic Blue 99 is found to be sensitizing when applied to a 46 yr old female as an ingredient of hair dye product.

In a study report given by American College of Toxicology (2007), Guinea pig maximisation test was performed to evaluate the sensitizing potential of Basic Blue 99 on 10 female albino Hartley/ Dunkin guinea pigs. No evidence of delayed type hypersensitivity were observed. Therefore, Basic Blue 99 is non sensitizing to the skin of Guinea pigs.

In a study from the above same reference, Mouse local lymphnode assay (LLNA) was performed to evaluate the contact allergenic potential of Basic Blue 99 when administered to the dorsum of both ear lobes of CBA/J female mice in the concentration of 1%, 5%, and 25% Basic Blue 99. An increased incorporation of 3H-thymidine were observed at 0.7-, 1.1-, and 1.1-fold, respectively as compared to positive-control mice had an increased incorporation of 3H-thymidine at 2.4-, 3.7-, and 7.0-fold, respectively as compared to the solvent control. Therefore, Basic Blue 99 is non sensitizing to the skin of Guinea pigs.

Hence, based on the above initial 4 case study and 1 animal study, it can be concluded that the substance Basic Blue 99 (CAS no 68123-13-7) classify as a skin sensitizer.

Though, negative skin sensitizer studies are also available but the positive skin sensitizer studies are on human and of Klimisch 2.

Thus, as per the CLP regulation, Basic Blue 99 (CAS no 68123-13-7) classify as a skin sensitizer.

Migrated from Short description of key information:
Basic Blue 99 was considered to be Sensitizing when tested by prick test in woman.

Justification for selection of skin sensitisation endpoint:
It is a resent case report of good data and of Klimisch 2