Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin sensitization:

Based on the weight of evidence used and as per the CLP classification, the test material 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl), sodium salt (915-67-3) does not classify as a skin sensitizer.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data from peer - reviewed journals
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
to assess the skin sensitizing potential of the test chemical
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route:
other: no data
Vehicle:
no data
Concentration / amount:
no data
Route:
other: no data
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
no data
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified
Reading:
other: mean
Group:
test chemical
Dose level:
no data
No. with + reactions:
0
Clinical observations:
no data
Remarks on result:
other: Reading: other: mean. Group: test group. Dose level: no data. No with. + reactions: 0.0. Clinical observations: no data.

Not Specified

Interpretation of results:
not sensitising
Conclusions:
In experiments with guinea-pigs, it was found that Amaranth had no sensitization activity
Executive summary:

In experiments with guinea‐pigs, it was found that Amaranth had no sensitization activity

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Various peer reviewed articles and from QSAR prediction to determine the sensitizing potential of the test compound 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl), sodium salt (CXAS 915-67-3). the summary is as below:

 

From Joint FAO/WHO Expert Committee on Food Additives which met in Geneva, 14‐23 April 1975; experiment study done on guinea‐pigs, it was found that Amaranth had no sensitization activity.

 

The sensitization potential of Acid Red 27 [also known as Amaranth] was estimated by using a quantitative structure–activity relationship (QSAR) model. Prediction of sensitization potency

Structures identified were then imported into a molecular spreadsheet TSAR (Version 3.3, Accelrys Ltd., Cambridge, UK). Simplified Molecular Input Line Entry Specifications (SMILES, www.daylight.com), which are 1-dimensional representations of chemical structures, were generated. This list was filtered in order to remove any further duplicate structures, such as salt-containing ingredients (HCl and SO4)

Ranking the substances 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 sensitization potency numbers represent an arbitrary relative ranking scheme, which makes it possible to compare substances within the same group.

The predicted sensitizing potential of Acid Red 27 [also known as Amaranth] was estimated to be in the strong/moderate sensitizer group.

 

Skin sensitizing property of 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl), sodium salt (915-67-3) is predicted using QSAR toolbox version 3.3.

The substance 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl), sodium salt (915-67-3) is estimated to be not sensitizing in an in vivo test on human.

 

Based on the studies reviewed, it can be concluded that the test material 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl), sodium salt (915-67-3) is not a skin sensitizer.


Migrated from Short description of key information:
In experiments with guinea‐pigs, it was found that Amaranth had no sensitization activity

Justification for selection of skin sensitisation endpoint:
The test material Amaranth does not classify as a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitization:

Based on the weight of evidence used and as per the CLP classification, the test material 2,7-Naphthalenedisulfonic acid, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl), sodium salt (915-67-3) does not classify as a skin sensitizer.