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Description of key information

Skin Sensitization

Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.

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:
key study
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 journals
Qualifier:
according to guideline
Guideline:
other: Patch test
Principles of method if other than guideline:
Patch test were performed to determine the allergic 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
Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Patch tested subjects were mostly patients with various facial dermatoses.
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
1,2,10%
Day(s)/duration:
48 or 72 hours
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
1,2,10%
Day(s)/duration:
48 or 72 jhours
Adequacy of challenge:
not specified
No. of animals per dose:
327
Details on study design:
OTHER: Patch tested subjects were mostly patients with various facial dermatoses. Samples were prepared in 3 different concentrations using white petrolatum as a vehicle.Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself is not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration. Routine photo patch tests were also performed at the same time on most of the test subjects.
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1,2,10%
No. with + reactions:
0
Total no. in group:
327
Clinical observations:
No dermal reactions observed
Remarks on result:
no indication of skin sensitisation

Results of the Patch test

Concentration of test chemical in white petrolatum

Reactions

No of patients tested

Allergic

Irritant

10

2.5

0.6

327

2*

1.5

0

327

1

0.6

0

327

*- optimal concentration determined by the study

Interpretation of results:
other: not sensitizing
Conclusions:
Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.
Executive summary:

The test chemical was patch tested on patients with various facial dermatoses at three different concentrations to determine suitable concentrations for patch testing.The test chemical samples were prepared in 3 different concentrations(1,2,10%) using white petrolatum as a vehicle. Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself was not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration.Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Various studies have been reviewed to determine the sensitizing potential of the test chemical in living organisms. These include in vivo experimental studies on humans along with estimated results for the test chemical.

The test chemical was patch tested on patients with various facial dermatoses at three different concentrations to determine suitable concentrations for patch testing. The test chemical samples were prepared in 3 different concentrations (1,2,10%) using white petrolatum as a vehicle. Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself was not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration. Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.

This study is supported by the results of another study, where Chubu Patch Test Research Team has collaborated with 12 participating institutions to conduct a patch test for the test chemical. Among outpatients at the 12 participating institutions, the targeted patients where those who were suspected of cosmetic skin inflammation or post-inflammatory pigmentation. There were a total of 327 cases of 45 males and 282 females ranging in age from 12 to 78 years old. The patch test unit used Finn-chamber (Epitest, Finland) -Scanpor tape (Norgesplaster, Norway). The artificial light source for the light patch test was FL20SBLB or BL equipped with Dermaray I or type I (Eisai), and the irradiation energy was 3 J / cm2 (at 365 nm) or more. The test chemical was based on white petrolatum and has three levels of concentration i.e 10%, 2% and 1%. The patch test and the light patch test were performed according to the International Contact Dermatitis Research Team (ICDRG) standards, and the results of each arriving facility were registered in the following code: 0:- ; 1: Ph? + ; 2: Ph + ; 3: Ph廾or more, 4: + ?, 5: +, 6: Over and over, 7: IR? (Stimulation response + based on Japanese standard); 8: IR (Stimulated response廾over Japanese standard source), 9: NT (not tested). The computer used was FACOM 230-15 (Fujitsu) Hara. Of the 327 patients tested, significant stimulation response was observed only in 1 case with 10% test chemical.  No reactions were observed in almost 300 patients when tested 10, 2, 1% test chemical in petrolatum. Based on these observations, the test chemical can be considered to be not sensitizing to skin.

The experimental results indicate a strong possibility that the test chemical was indeed not sensitizing to skin. Hence, it can be classified under the category “Not Classified” according to CLP Regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The experimental results indicate a strong possibility that the test chemical was indeed not sensitizing to skin. Hence, it can be classified under the category “Not Classified” according to CLP Regulation.