[8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from modelling database developed by the National Food Institute, Technical University of Denmark.

Principles of method if other than guideline:

The predicton is done using Danish (Q)SAR Database

GLP compliance:

no

Type of study:

other: Allergic contact dermatitis (ACD) in guinea pig and human

Species:

other: guinea pig and human

Strain:

not specified

Sex:

not specified

Route:

other: no data

Vehicle:

no data

Route:

other: no data

Vehicle:

no data

Group:

test chemical

Clinical observations:

Allergic Contact Dermatitis in Guinea Pig and Human give positive result

Remarks on result:

other: Group: test group. Clinical observations: Allergic Contact Dermatitis in Guinea Pig and Human give positive result.

Allergic Contact Dermatitis in Guinea Pig and Human give positive result

Interpretation of results:

sensitising

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be positive on guinea pig and human. Thus it can be concluded that the substance [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride has positive skin sensitization effects and based on the CLP criteria for classification it can be classified as skin sensitizer.

Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be positive on guinea pig and human. Thus it can be concluded that the substance[8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloridehas positive skin sensitization effects and based on the CLP criteria for classification it can be classified as skin sensitizer.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Skin sensitization:

Based on the QSAR prediction done using the Danish (Q) SAR Database, the skin sensitization was estimated to be positive on guinea pig and human. Thus, it can be estimated that the substance [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloridehas positive skin sensitization effects and based on the CLP criteria for classification it can be classified as skin sensitizer.

In a opinion given by Scientific Committee on Consumer Safety for Basic Brown 16 (2013), skin sensitization were evaluated by using mouse local lymphnode assay (LLNA) in a group of four female mice were treated daily with Basic Brown 16 in the concentrations of 5, 10 and 25% (w/v) in ethanol:water, 7:3 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. No effects on survival of treated mice were observed and no clinical signs of toxicity were observed in treated mice. Stimulation Index (S.I.) of 3 is referred to as the EC3 value. EC3 value was derived to be 12.2% in test group and 11.7% in Positive control group. Hence, on the basis of Stimulation Index, authors considered Basic Brown 16 to be a skin sensitizer under the conditions of the test. 

In a estimation conducted by H. SOSTEDet al(2004) for read across; sensitization potential of Basic Red 76 was estimated by using a quantitative structure–activity relationship (QSAR) model. Prediction of sensitization potency ranking of substances was according to their sensitization potential. The TOPS-MODE QSAR model was used in order to estimate the likely sensitization potency in 1 of 3 bands: * strong/moderate sensitizers, * weak sensitizers and * extremely weak or non-sensitizers. The predicted sensitizing potential of Basic Red 76 was estimated to be in the weak sensitizers.

In a opinion given by Scientific Committee on Consumer Safety for (2003) for read across, skin sensitization were evaluated by using by Guinea Pig Maximization Assay treated with Basic Red 76 as a 0.1% w/v solution in water (injection 1). Freund’s complete adjuvant was diluted with an equal volume of water (injection 2). A 1:1 mixture of the material solution and Freund’s complete adjuvant solution was prepared (injection 3). The induction of sensitization was made through 3 pairs of 2 intradermal injections. One week after the injections a solution of 75% w/v of the material in distilled water applied topically. The animals were challenged topically two weeks after the induction period using test chemical at a concentration of 25% w/v.The intradermal injection caused an irritation response that was still present at the time of the topical induction. Following the challenge, erythema was observed in 5 of the animals at 24 hours, but had resolved by 48 hours. Therefore, sensitizing potential of Basic Red 76 can be considered as ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical. The CLP classification for the test chemical is ‘Not Classified’

Similar to above reference, in 2011 for read across Basic Red 76, sensitization potential of Basic Red 76 was evaluated by Mouse Lymphnode Assay. A dilution of the test item in a mixture of ethanol:water (7:3 v/v) was made shortly before each dosing. Although acetone:olive oil (4:1 v/v) is recommended, ethanol:water (7:3 v/v) was selected as the vehicle due to pre-tests on the solubility of the test item. The highest non-irritating, “technically applicable” test item concentration was determined in a pre-test with 4 mice. Based on these test results 2.5%, 5% and 10% solutions were chosen for the main study. Five days after the first topical application, all mice were administered with radio-labelled thymidine (³H-TdR) by intravenous injection via the tail vein. Approximately 5 hours after ³H-TdR application all mice were euthanized. The draining lymph nodes were excised and pooled for each experimental group. Stimulation Index of the test chemical was determined to be in range 0.9-1.3. Calculation of the EC 3 value was not performed as none of the test concentrations produced a stimulation index of 3 or above. Therefore, Based on the criteria of the test system, Basic Red 76 was a non-sensitizer when tested up to a concentration of 10% (w/v) in ethanol: water (7:3 v/v) in mice.

Based on the available data for target Basic Brown 16 and read across Basic Red 76, it can be concluded that the substance can be classified as per the criteria of CLP regulation for skin sensitization.

Migrated from Short description of key information:
Based on the QSAR prediction it can be estimated that the substance [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloridehas positive skin sensitization effects and based on the CLP criteria for classification it can be classified as skin sensitizer.

Justification for selection of skin sensitisation endpoint:
Estimated that the substance [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloridehas positive skin sensitization effects

Justification for classification or non-classification

It can be concluded that the substance Basic Brown 16 and read its across Basic Red 76 can be classified as per the criteria of CLP regulation for skin sensitization.