Registration Dossier

Administrative data

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. Based on the summarized,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, 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:
data from handbook or collection of data
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on functionally similar chemicals
Principles of method if other than guideline:
The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization of test chemical.
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on functionally similar chemicals
Species:
other: guinea pigs, humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no data available
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
2% in white petrolatum
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
Freund´s Complete Adjuvant (FCA) and physiological saline (1:1), test item at 5% in 1 % CMC and 5 % dilution of the test item in 1% CMC in a 1:1 mixture with FCA / physiological saline
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
50 % in 1 % CMC
Day(s)/duration:
48 hours
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% petrolatum
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
2% in white petrolatum
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
10 % in 1 % CMC
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No. of animals per dose:
1. 16 patients
2. 32 patients
3. 10 females guinea pigs
Details on study design:
1.Details on study design
OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as
?+. + and ++ categories.

2.A group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.
The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures.

3.Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A.1. INDUCTION EXPOSURE: Intradermal Induction:
- No. of exposures:1
- Exposure period:7 days
- Test groups:10 females
- Control group:5 females
- Site:
- Frequency of applications:
- Duration: 7 days
- Concentrations:
•Freund´s Complete Adjuvant (FCA) and physiological saline (1:1)
•Acid Red 52 at 5% in 1 % CMC
•5 % dilution of the Acid Red 52 in 1% CMC in a 1:1 mixture with FCA / physiological saline
A.2. INDUCTION EXPOSURE: Epidermal Induction
- No. of exposures:1
- Exposure period:48 hours
- Test groups: 10 females
- Control group: 5 females
- Site:
- Frequency of applications:
- Duration: 48 hours
- Concentrations: 50% in 1% CMC solution

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on day 22
- Exposure period:24 hours
- Test groups: 10 females
- Control group: 5 females
- Site: different part of the skin
- Concentrations: 10% in 1% CMC solution
- Evaluation (hr after challenge): at 24 and 48 hours removal of the dressings
Challenge controls:
no data available
Reading:
other: 1. 1st reading
Hours after challenge:
168
Group:
test group
Dose level:
Not specified
No. with + reactions:
1
Total no. in group:
16
Clinical observations:
one positive reaction was observed of 16 patients tested
Remarks on result:
no indication of skin sensitisation
Reading:
other: 2.1st reading
Group:
test group
Dose level:
2% in white petrolatum
No. with + reactions:
0
Total no. in group:
32
Clinical observations:
The test chemical did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3.1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
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
Interpretation of results:
other: not sensitizing
Conclusions:
Based on the available data for the functionally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, C.I Pigment Red 169 was estimated to be not sensitizing to skin.
Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of C.I Pigment Red 169.

The sensitization potential of the functionally similar test chemical was determined by performing patch tests on humans. The dye was applied in Finn Chambers to the skin of 16 patients. The dermal reactions were read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.

Positive reaction was reported in 1 patient of the 16 tested. Hence, the test chemical can be considered as a non- sensitizer in humans.

This is supported by the results of study performed on a group of 32 patients with p -aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.

The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures.

The test chemical did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers.

Hence, the test chemical can be considered to be not sensitizing to skin.

 

The above results are further supported by the OECD 406 Guideline study performed to determine the dermal sensitization potential of the other functionally similar chemical. 10 females and 5 female Himalayan spotted guinea pigs were used in the test and control groups respectively.

In induction treatment, 10 females in test group, 5 females in control group were used. Animals were induced with intradermal induction of Freund´s Complete Adjuvant (FCA) and physiological saline (1:1), test item at 5% in 1 % CMC and 5 % dilution of the test item in 1% CMC in a 1:1 mixture with FCA / physiological saline on day 1. After 7 days, epidermal induction of sensitization (day 8) was conducted under occlusion with the test item at 50 % in 1 % CMC for 48 hours. The challenge was performed at day 22 by application of the test item at 10 % in 1 % CMC under occlusive patch for 24 h at a different part of the skin. Observations were made at 24 and 48 hours removal of the dressing.

After challenge exposure, no skin reactions were observed. Hence, the test chemical was considered to be non sensitizing to the Himalayan spotted albino guinea pigs.

Based on the available data for the functionally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, C.I Pigment Red 169 was estimated to be not sensitizing to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
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. The studies are as mentioned below:

 

The sensitization potential of the test chemical was determined by performing patch tests on humans. The dye was applied in Finn Chambers to the skin of 16 patients. The dermal reactions were read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. Positive reaction was reported in 1 patient of the 16 tested. Hence, the test chemical can be considered as a non- sensitizer in humans.

 

 

The above results was supported by a patch test conducted for similar read across chemical on a group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series. The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures. The test chemical did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers . Hence, the test chemical can be considered to be not sensitizing to skin.

 

 

The above results were further supported by the dermal sensitization study of another read across chemical conducted in guinea pigs. The study was performed as per OECD 406 Guidelines. 10 females and 5 female Himalayan spotted guinea pigs were used in the test and control groups respectively. In induction treatment, 10 females in test group, 5 females in control group were used. Animals were induced with intradermal induction of Freund´s Complete Adjuvant (FCA) and physiological saline (1:1), test item at 5% in 1 % CMC and 5 % dilution of the test item in 1% CMC in a 1:1 mixture with FCA / physiological saline on day 1. After 7 days, epidermal induction of sensitization (day 8) was conducted under occlusion with the test item at 50 % in 1 % CMC for 48 hours. The challenge was performed at day 22 by application of the test item at 10 % in 1 % CMC under occlusive patch for 24 h at a different part of the skin. Observations were made at 24 and 48 hours removal of the dressing. After challenge exposure, no skin reactions were observed. Hence, the test chemical was considered to be non-sensitizing to the Himalayan spotted albino guinea pigs.

Based on the above summarized studies for target chemical 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”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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