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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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, 1423 April 1975; experiment study done on guineapigs, 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.