Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes

Endpoint summary

Description of key information

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4). The studies are as mentioned below:

 

The Maximization test of read across chemical was summarized by secondary source in female 15 (10 test and 5 control) Guinea pig to determine the degree of sensitization caused by the chemical. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction. The test areas are pretreated with 10 sodium-laureth-sulfates (SLS) 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No known skin sensitization reactions were observed in treated as well as control group. Hence the test chemical was considered to be not sensitizing.

 

The above result was further supported by a maximization test reported on human subjects by safety assessment report to assess the skin sensitization potential of another read across chemical. During the test, 25 healthy adults were treated with 0.3% (0.3g) of under occlusive condition for 48 hours. None of the treated volunteers showed positive allergic reaction. Thus the test chemical was considered to be irritating to the skin of human subjects’.

 

Based on the above summarized studies for target chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin sensitization study of test chemical was conducted on guinea pigs to assess its skin sensitization effects.

GLP compliance:

not specified

Type of study:

other: 1.guinea pig maximisation test 2.human maximisation test

Justification for non-LLNA method:

not specified

Specific details on test material used for the study:

- Name of test material: Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes
- Molecular formula : C18H11NO8S2.Al
- Molecular weight : 460.39 g/mol
- Smiles notation : O=C1c2ccccc2C(=O)C1=C1C=Cc2cc3c4cc2N{-}1.[Al]{3+}(.O{-}S3(=O)=O).O{-}S4(=O)=O
- Substance type : Organic
- Physical state : Solid

Species:

other: 1.guinea pig 2.human

Strain:

other: 1.Ibm: GOHI 2.Not specified

Sex:

female

Details on test animals and environmental conditions:

1.not specified

Route:

other: 1.intradermal and epicutaneous

Vehicle:

other: 1% CMC (carboxymethyl cellulose)

Concentration / amount:

intradermal induction: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1% CMC

Day(s)/duration:

18 hours

Adequacy of induction:

not specified

Route:

other: 2.intradermal and epicutaneous

Vehicle:

petrolatum

Concentration / amount:

0.3%(0.3 gm)

Day(s)/duration:

48 hours

Adequacy of induction:

not specified

No.:

#1

Route:

other: 1.epicutaneous, occlusive

Vehicle:

other: 1% CMC (carboxymethyl cellulose)

Concentration / amount:

25% dilution in 1% CMC

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No.:

#1

Route:

other: 2. epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

0.3%(0.3 gm)

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No. of animals per dose:

1.15 female (10 test and 5 control)
2.25 subjects

Details on study design:

1.Details on study design
RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:1
- Exposure period: No data available
Intradermal induction: 1 week
Epidermal induction:18 hr
- Test groups:10 Guinea pig
- Control group: 5Guinea pig
- Site:nuchal region
- Frequency of applications: 1
- Duration: No data available
- Concentrations:Intradermal induction: 5% dilution of test item in 1% CMC and in an
emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1% CMC

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:No data
- Exposure period:No data
- Test groups: 10 Guinea pig
- Control group: 5Guinea pig
- Site: No data
- Concentrations:25% dilution in 1% CMC
-Evaluation (hr after challenge):24 and 48 hr

2.- Exposure period:48-hrs
- Test groups:Yes
- Control group:No data
- Concentrations:0.3 gm

Challenge controls:

1.The animals of the control group were epidermally induced with 1% CMC under occlusion.
2.not specified

Positive control substance(s):

yes

Remarks:

2-mercaptobenzothiazole

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No skin sensitization was observed in treated group

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.3%(0.3gm)

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

None of the volunteers showed positive skin reaction.

Remarks on result:

no indication of skin sensitisation

Cellular proliferation data / Observations:

1.No skin sensitization was observed in treated group
2None of the volunteers showed positive skin reaction.

1.

Skin reactions after the challenge procedure:

	After 24 hours		After 48 hours
	Positive / total	% positive	Positive / total	% positive
Control Group
test chemical 1% CMC (left flank)	0 / 5	0	0 / 5	0
1% CMC only (right flank)	0 / 5	0	0 / 5	0
Test Group
test chemical , 25% in 1% CMC (left flank)	0 / 10	0	0 / 10	0
1% CMC only (right flank)	0 / 10	0	0 / 10	0

2.Not specified

Interpretation of results:

other: not sensitising

Conclusions:

The study concluded that the test substance was considered as non skin sensitizer.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4). The studies are as mentioned below:

 

The Maximization test of read across chemical was summarized by secondary source in female 15 (10 test and 5 control) Guinea pig to determine the degree of sensitization caused by the chemical. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction. The test areas are pretreated with 10 sodium-laureth-sulfates (SLS) 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No known skin sensitization reactions were observed in treated as well as control group. Hence the test chemical was considered to be not sensitizing.

 

The above result was further supported by a maximization test reported on human subjects by safety assessment report to assess the skin sensitization potential of another read across chemical. During the test, 25 healthy adults were treated with 0.3% (0.3g) of under occlusive condition for 48 hours. None of the treated volunteers showed positive allergic reaction. Thus the test chemical was considered to be irritating to the skin of human subjects’.

 

Based on the above summarized studies for target chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4). The studies are as mentioned below:

 

The Maximization test of read across chemical was summarized by secondary source in female 15 (10 test and 5 control) Guinea pig to determine the degree of sensitization caused by the chemical. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction. The test areas are pretreated with 10 sodium-laureth-sulfates (SLS) 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No known skin sensitization reactions were observed in treated as well as control group. Hence the test chemical was considered to be not sensitizing.

 

The above result was further supported by a maximization test reported on human subjects by safety assessment report to assess the skin sensitization potential of another read across chemical. During the test, 25 healthy adults were treated with 0.3% (0.3g) of under occlusive condition for 48 hours. None of the treated volunteers showed positive allergic reaction. Thus the test chemical was considered to be irritating to the skin of human subjects’.

 

Based on the above summarized studies for target chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Justification for classification or non-classification

The skin sensitization potential of test substance Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS No: 94891-32-4) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.