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Toxicological information

Skin sensitisation

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Administrative data

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:
data from handbook or collection of data
Remarks:
Experimental data from various test chemicals
Justification for type of information:
Data for the target chemical is summarized based on data from various test chemicals
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
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:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Human repeat insult patch test (HRIPT) was performed to determine the sensitizing potential of the test chemical
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Not specified
Species:
human
Sex:
not specified
Route:
other: occlusive patches
Vehicle:
other: Detergent
Remarks:
The detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
Route:
other: occlusive patches
Vehicle:
other: Detergent
Remarks:
the detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
No. of animals per dose:
70 human subjects-a 0.5% aqueous solution of a detergent mixture containing 10% brightener
Challenge controls:
Challenge applications were made 2 weeks later-other details not available
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
70
Clinical observations:
No skin sensitization was observed
Remarks on result:
no indication of skin sensitisation

The material did not appear to cause irritation. None of the subjects was sensitized.

Interpretation of results:
not sensitising
Conclusions:
The test chemical did not induce any allergic response on the human case subjects. Hence the test chemical is not likely to classify as a "skin sensitizer"
Executive summary:

In the patch test in humans, the test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. No sensitization reaction was observed. The test chemical did not induce any allergic response on the human case subjects. Hence the test chemical is not likely to classify as a "skin sensitizer"

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from a secondary source.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin sensitization study was performed to determine the senstizing potential of the test chemical
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD
Species:
other: Humans
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
No Data Available
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1 mg/ml
Day(s)/duration:
2 days
Adequacy of induction:
not specified
No. of animals per dose:
103 female subjects
Details on study design:
No Data Available
Challenge controls:
No Data Available
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
1 mg/ml
No. with + reactions:
0
Total no. in group:
103
Clinical observations:
No Clinical observation were seen in any of the subjects.
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not sensitizing
Conclusions:
Based on all the observations and results, it was concluded that the test chemical was not found to be sensitizing to the human subject, and is thus likely to be considered as 'Non-Sensitizing' as per CLP.
Executive summary:

A skin sensitization study was performed using the test chemical on human female subjects so as to identify the sensitizing potential of the test chemical. 103 white females were subjected to ten repeated patch tests (intervals not given) and challenge performed fourteen days after last patch test, totaling eleven applications. A one-half inch square of white blotting paper was impregnated with 1 mg/ml aqueous solution of test material and then was applied on clean back and covered with an "Elasto-patch" plaster. The patch was allowed to remain in contact with the skin for forty-eight hours. Upon removal the test areas were observed for immediate reaction. There was no evidence of primary irritation upon removal of the 48 hour patch tests and no indication of sensitization potential on the challenge. Therefore, based on all the observations and results, it was concluded that the test chemical was not found to be sensitizing to the human subject, and is thus likely to be considered as 'Non-Sensitizing' as per CLP.

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data from handbook or collection of data and safety assessment report
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
The skin sensitization test was conducted in guinea pigs to determine the sensitization potential of test chemical .
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Adequacy of induction:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
No data
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified
Positive control results:
No data
Reading:
1st reading
Group:
test chemical
Dose level:
No data
Clinical observations:
No signs of sensitization observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitising
Conclusions:
The test material was considered to be non-sensitizing to the guinea pigs skin and hence it is not likely to classify as a "skin senstizer".
Executive summary:

The skin sensitization study of the test chemical was carried out in guinea pigs to determine its sensitization efficacy.

Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the skin of guinea pigs and hence it is not likely to classify as a "skin senstizer".

Data source

Reference
Reference Type:
publication
Title:
WoE of skin sensitization for CAS no 72507-17-2
Author:
Sustainability Support Services (Europe) AB
Year:
2019
Bibliographic source:
WoE report, Sustainability Support Services (Europe) AB, 2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
WoE for the target CAS is summarized based on data from various test chemicals
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen tetrasodium bis[2-[[6-[[4-chloro-6-[3-sulphoanilino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]benzoato(4-)]chromate(5-)
EC Number:
277-492-0
EC Name:
Hydrogen tetrasodium bis[2-[[6-[[4-chloro-6-[3-sulphoanilino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]benzoato(4-)]chromate(5-)
Cas Number:
73507-17-2
Molecular formula:
C52H28Cl2CrN14O18S44Na
IUPAC Name:
Hydrogen tetrasodium bis[2-[[6-[[4-chloro-6-[3-sulphoanilino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]benzoato(4-)]chromate(5-)
Details on test material:
- Name of the test chemical: Hydrogen tetrasodium bis[2-[[6-[[4-chloro-6-[3-sulphoanilino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]benzoato(4-)]chromate(5-)
- Molecular formula: C52H28Cl2CrN14O18S4.H.4Na
- Molecular weight: 2693.61 g/mol
- Substance type: Organic

In vivo test system

Test animals

Species:
other: 2/3. Humans; 4. Guinea pigs
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: occlusive patches / 2
Vehicle:
other: Detergent
Remarks:
The detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
Route:
other: 2
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
3
Concentration / amount:
1 mg/mL
Day(s)/duration:
2 days
Adequacy of induction:
not specified
Challengeopen allclose all
Route:
other: occlusive patches / 2
Vehicle:
other: Detergent
Remarks:
the detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
Route:
other: 2
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
No. of animals per dose:
2. 70 human subjects-a 0.5% aqueous solution of a detergent mixture containing 10% brightener
3. 103 female subjects
Challenge controls:
2. Challenge applications were made 2 weeks later-other details not available

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
70
Clinical observations:
No skin sensitization was observed
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
1 mg/mL
No. with + reactions:
0
Total no. in group:
103
Clinical observations:
No Clinical observation were seen in any of the subjects.
Remarks on result:
no indication of skin sensitisation
Remarks:
3

Any other information on results incl. tables

The material did not appear to cause irritation. None of the subjects was sensitized.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
The test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".
Executive summary:

Data available for the test chemicals was reviewed to determine the skin sensitization study of the test chemical. The studies are as mentioned below:

In the patch test in humans, the test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. No sensitization reaction was observed. The test chemical did not induce any allergic response on the human case subjects. Hence the test chemical is not likely to classify as a "skin sensitizer" .

Another skin sensitization study was also performed using the test chemical on human female subjects so as to identify the sensitizing potential of the test chemical. 103 white females were subjected to ten repeated patch tests (intervals not given) and challenge performed fourteen days after last patch test, totaling eleven applications. A one-half inch square of white blotting paper was impregnated with 1 mg/ml aqueous solution of test material and then was applied on clean back and covered with an "Elastopatch" plaster. The patch was allowed to remain in contact with the skin for forty-eight hours. Upon removal the test areas were observed for immediate reaction. There was no evidence of primary irritation upon removal of the 48 hour patch tests and no indication of sensitization potential on the challenge. Therefore, based on all the observations and results, it was concluded that the test chemical was not found to be sensitizing to the human subject, and is thus likely to be considered as 'Non-Sensitizing' as per CLP.

The skin sensitization study of the test chemical was carried out in guinea pigs to determine its sensitization efficacy. Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the skin of guinea pigs and hence it is not likely to classify as a "skin senstizer".

Based on the data available and applying the weight of evidence approach, the test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".