[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]iron

Endpoint summary

Description of key information

Data available for the structurally similar read across chemicals has been reviewed to estimate the skin sensitization potential of the test chemical. Based on the summarized studies for target chemical and its structurally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, the test chemical can-not be classified as 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:

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:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on various test chemicals

Justification for type of information:

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

Reason / purpose for cross-reference:

read-across source

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:

The skin sensitization potential of test chemical was assessed on the basis of various summarized studies which were conducted on guinea pigs and represented as study 1, 2 and 3 for WoE-2,WoE-3 and WoE-4 respectively.

GLP compliance:

not specified

Type of study:

other: Study 1:Buehler test ; Study 2: guinea pig maximisation test; Study 3:not specified

Justification for non-LLNA method:

Currently no LLNA Study is available for assessment.

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Route:

other: Study 1:epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

0.5 ml of 1% w/v aqueous suspension

Day(s)/duration:

nine applications for 5 hours

Adequacy of induction:

not specified

Route:

other: Study 2:intradermal

Vehicle:

water

Concentration / amount:

0.1 mL 1% aqueous solution

Day(s)/duration:

3 times/day for 5 days

Adequacy of induction:

not specified

Route:

other: Study 3: epicutaneous,

Vehicle:

other: 10% oil suspension

Concentration / amount:

test chemical in 10% oil suspension

Day(s)/duration:

Not specified

Adequacy of induction:

not specified

No.:

#1

Route:

other: Study 1:epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

0.5 ml of 1% w/v aqueous suspension

Day(s)/duration:

5 hours

Adequacy of challenge:

not specified

No.:

#1

Route:

other: Study 2:epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

0.1 mL of 1% aqueous solution

Day(s)/duration:

not specified

Adequacy of challenge:

not specified

No.:

#1

Route:

other: Study 3: epicutaneous, occlusive

Vehicle:

other: 10% oil suspension

Concentration / amount:

test chemical in 10% oil suspension

Day(s)/duration:

not specified

Adequacy of challenge:

not specified

No. of animals per dose:

Study 1:10 albino guinea pigs
Study 2:not specified
Study 3:no data available

Details on study design:

Study 1:
RANGE FINDING TESTS: NO DATA AVAILABLE

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 5 h
- Test groups: 10
- Control group: NO DATA AVAILABLE
- Site: no data available
- Frequency of applications:
- Duration: 9 topical application for 5 hours
- Concentrations: 0.5 ml of 1% w/v aqueous suspension

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: no data available
- Exposure period: 5 hours
- Test groups: 10
- Control group: 4
- Site: no data available
- Concentrations: 0.5 ml of 1% w/v aqueous suspension
- Evaluation (hr after challenge): The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hrs after the challenge.

OTHER: During the induction phase, Dermal irritation readings were recorded according to Draize (1965) at 24 and 48 hrs after each application.The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hrs after the challenge.

Study 2:MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 times/day
- Exposure period: 5 days
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Frequency of applications: 3 times
- Duration: 0.1 ml 1% aqueous solution
- Concentrations:


B. CHALLENGE EXPOSURE
- No. of exposures: single
- Concentrations: 0.1 mL of 1% aqueous solution

Study 3: :not specified

Challenge controls:

Study 1:Four unexposed control animals taken from the same population also received duplicate topical patches of the same dose during the challenge phase.
Study 2:not specified
Study 3:not specified

Positive control substance(s):

not specified

Reading:

other: Study 1: 1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

0.5 ml of 1% w/v aqueous suspension

No. with + reactions:

0

Clinical observations:

No evidence of dermal sensitization was observed. No abnormal clinical signs were observed during the study.

Remarks on result:

no indication of skin sensitisation

Reading:

other: Study 2:1st reading

Group:

test chemical

Dose level:

0.1 mL of 1% aqueous solution

No. with + reactions:

0

Clinical observations:

no dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Reading:

other: Study 3:1st reading

Group:

test chemical

Dose level:

Test chemical in a 10% oil suspension

No. with + reactions:

0

Clinical observations:

No skin sensitization was observed in treated guinea pigs.

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: Not sensitising

Conclusions:

Based on the result obtained from the studies available for the structurally read across chemical, it can be estimated that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing.

Executive summary:

The skin sensitization potential of test chemical was estimated on the basis of various summarized studies available for the structurally read across chemicals which were conducted on guinea pigs and humans. These studies have been summarized as below;

 

Study 1:

Buehler test was performed to determine the allergic potential of the test chemical in guinea pigs. Ten albino guinea pigs were used for the test. All test animals received nine topical applications of the test article (0.5 ml of 1% w/v aqueous suspension) during the induction phase. Each application was patched for 5 hrs. Two weeks after the last exposure, the test animals were challenged for 5 hours with duplicate topical patches of the same dose as described in the induction phase. Four unexposed control animals taken from the same population also received duplicate topical patches of the same dose during the challenge phase. During the induction phase, dermal irritation readings were recorded according to Draize (1965) at 24 and 48 hrs after each application. The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hours after the challenge. No evidence of dermal sensitization was observed. No abnormal clinical signs were observed during the study. Hence, the test chemical can be considered to be not sensitizing to skin of guinea pigs.

 

Study 2:

The skin sensitization study was performed on guinea pigs to observe the sensitizing efficacy of the test chemical. Guinea pigs were induced with intracutaneous injections of a 0.1 mL 1% aqueous solution 3 times/day for 5 days. After 4 weeks, animals were topically challenged with 0.1 mL of 1% aqueous solution. Since guinea pigs did not show any cutaneous reaction, the test material was considered to be non-sensitizing.

 

Study 3:

Skin sensitization study was conducted to determine the skin sensitization potential of test chemical. When the test chemical was applied on skin at concentration of test chemical in a 10% oil suspension (30- times), no skin sensitization reactions were observed. Therefore, the test chemical was considered as not sensitizing to the skin of treated guinea pigs.

The aim of the above summarized studies was to investigate the possibility of causing contact sensitization by the test chemical via dermal route. These studies were performed for the structurally similar read across chemical on humans and guinea pigs by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical is a potential contact allergen. Thus an interpretation can be drawn from these studies, that the chemical is not able to cause skin sensitization and hence can be considered as not sensitizing on skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitization potential of test chemical was estimated on the basis of various summarized studies available for the structurally read across chemicals which were conducted on guinea pigs and humans. These studies have been summarized as below;

 

Study 1:

Buehler test was performed to determine the allergic potential of the test chemical in guinea pigs. Ten albino guinea pigs were used for the test. All test animals received nine topical applications of the test article (0.5 ml of 1% w/v aqueous suspension) during the induction phase. Each application was patched for 5 hrs. Two weeks after the last exposure, the test animals were challenged for 5 hours with duplicate topical patches of the same dose as described in the induction phase. Four unexposed control animals taken from the same population also received duplicate topical patches of the same dose during the challenge phase. During the induction phase, dermal irritation readings were recorded according to Draize (1965) at 24 and 48 hrs after each application. The application sites were graded for irritation (according to Draize, 1965) 24 and 48 hours after the challenge. No evidence of dermal sensitization was observed. No abnormal clinical signs were observed during the study. Hence, the test chemical can be considered to be not sensitizing to skin of guinea pigs.

 

Study 2:

The skin sensitization study was performed on guinea pigs to observe the sensitizing efficacy of the test chemical. Guinea pigs were induced with intracutaneous injections of a 0.1 mL 1% aqueous solution 3 times/day for 5 days. After 4 weeks, animals were topically challenged with 0.1 mL of 1% aqueous solution. Since guinea pigs did not show any cutaneous reaction, the test material was considered to be non-sensitizing.

 

Study 3:

Skin sensitization study was conducted to determine the skin sensitization potential of test chemical. When the test chemical was applied on skin at concentration of test chemical in a 10% oil suspension (30- times), no skin sensitization reactions were observed. Therefore, the test chemical was considered as not sensitizing to the skin of treated guinea pigs.

The aim of the above summarized studies was to investigate the possibility of causing contact sensitization by the test chemical via dermal route. These studies were performed for the structurally similar read across chemical on humans and guinea pigs by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical is a potential contact allergen. Thus an interpretation can be drawn from these studies, that the chemical is not able to cause skin sensitization and hence can be considered as not sensitizing on skin.

Justification for classification or non-classification

The skin sensitization potential of test chemical and its structurally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the test chemical is unlikely to cause skin sensitization and hence can-not be classified as a skin sensitizer.