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Description of key information

2 of the 1092 patients tested showed allergic reactions to test chemical. Patch test reactions to test chemical were difficult to interpret, owing to extremely common irritant reactions. Based on this observation, the test chemical can be considered to be a potentially weak 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:
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:
To describe patients with positive patch test reactions to test chemical-related compounds in an occupational dermatology clinic.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not reported
Species:
other: humans
Strain:
not specified
Details on test animals and environmental conditions:
Source: Finnish Institute of Occupational Health (FIOH)
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1% in water
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1%
Adequacy of challenge:
not specified
No. of animals per dose:
1092 patients
Details on study design:
the dermal reactions were read two or three times: on D2/D3/D4 or D2/D3/D6 or D2/D5, depending on the day of application.
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% in water
No. with + reactions:
2
Total no. in group:
1 092
Clinical observations:
+++/++ reactions were observed
Remarks on result:
positive indication of skin sensitisation

Patch test reactions to cocamidopropyl betaine (CAPB) and its impurities during 2002–2009 (1092 patients)

 test substance (provider, vehicle)

 Allergic

(++/+++/+++) reactions, n(%)

 irritant reactions

n(%)

Test chemical [Chemotechnique Diagnostics], water  2 (0.2)  166 (5)

Interpretation of results:
other: sensitizing
Conclusions:
2 of the 1092 patients tested showed allergic reactions to test chemical. Patch test reactions to test chemical were difficult to interpret, owing to extremely common irritant reactions.Based on this observation, the test chemical can be considered to be a potentially weak skin sensitizer.
Executive summary:

The aim of the study was to describe patients with positive patch test reactions to test chemical-related compounds in an occupational dermatology clinic between 2002 -2009. The test chemical was tested 1% in distilled water. 1092 patients were patch tested with Finn Chambers® according to the recommendations of the International Contact Dermatitis Research Group. The dermal reactions were read two or three times: on D2/D3/D4 or D2/D3/D6 or D2/D5, depending on the day of application. The patch test reactions were rated +/++/+++. 2 of the 1092 patients tested showed allergic reactions to test chemical. Patch test reactions to test chemical were difficult to interpret, owing to extremely common irritant reactions. Based on this observation, the test chemical can be considered to be a potentially weak skin sensitizer.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In various studies,test chemical has been investigated for potential to cause dermal sensitization to a greater or lesser extent. The studies are based on in vivo experiments in humans, guinea pigs for the target chemical. The results are summarized as follows:

Study 1:

The aim of the study was to describe patients with positive patch test reactions to test chemical-related compounds in an occupational dermatology clinic between 2002 -2009. The test chemical was tested 1% in distilled water. 1092 patients were patch tested with Finn Chambers® according to the recommendations of the International Contact Dermatitis Research Group. The dermal reactions were read two or three times: on D2/D3/D4 or D2/D3/D6 or D2/D5, depending on the day of application. The patch test reactions were rated +/++/+++. 2 of the 1092 patients tested showed allergic reactions to test chemical. Patch test reactions to test chemical were difficult to interpret, owing to extremely common irritant reactions. Based on this observation, the test chemical can be considered to be a potentially weak skin sensitizer.

Study 2:

The aim of the study was to analyze whether volunteers with previous positive patch tests to test chemical would react in provocative use tests of a product containing test chemical. In order, better to differentiate irritant response from allergic reactions and also in order to reconfirm panelists’ sensitivity towards test chemical , 10 male/female volunteers were patch tested with 0.1%, 0.3%, 1.0% dilutions of test chemical. A matched control group was used. Except for a + reaction to 1% test chemical, there was no reaction to patch tests in the control group With the test chemical-sensitized group, there was a little more reactivity. 5/10 showed clear + reactions to 1% test chemical (typically at D3), whilst a further 3 gave marginal and/or irritant reactions. The observed Reactions showed a typically crescendo pattern (with no reactions at D2 but reactions occurring by D3) suggesting a true allergic reaction. Hence, the test chemical when used or tested above 1% can cause allergic reactions to humans.

Study 3:

Patch tests were performed on a total of 210 patients with clinically suspected allergic contact dermatitis to skin-care products, as well as patients with dermatitis of the head and neck area to determine the allergic potential of test chemical. The patients were patch-tested with a 1% aqueous solution of test chemical applied to small occluded patches on the backs of the patients for 48 h. Readings were performed at 48 h and at a later time, usually 96 h. Grading of reactions was done on a 0 to 3+ scale as used by the North American Contact Dermatitis Group. The patch test reactions were considered relevant to test chemical if the patient could identify one or more products containing test chemical that he or she had used before testing and if the dermatitis improved after the patient had avoided using the product. Of the 210 patients patch-tested, 12 had positive responses to test chemical, the subjects had reactions which showed up at either 48 or 96 h. The possibility of test chemical being weak allergen to pre-sensitized humans cannot be ruled out. Hence, the test chemical can be considered to be weak sensitizer to skin.

Study 4:

Magnusson and Kligman method was used to study the capacity of test chemical to induce delayed type contact dermatitis in guinea pigs. 40 albino guinea pigs of both sex were distributed evenly into 2 groups- test and vehicle control. The concentrations of test chemical were as follows - Intradermal induction - 0.1% aqueous solution, Epicutaneous induction and challenge exposure - 10% aqueous solution. The induction exposure was a 2 step process- On day 1, guinea pigs were injected with 3 pairs of injections in an area of the back. The injections comprised of 0.1 ml FCA, 0.1ml test chemical without FCA, 0.1 ml test chemical in emulsified FCA. The control groiup were treated in the same way, where the test chemical was replaced with the vehicle.7 days later, the same area was clipped and test chemical was spread along an area of 2 -4 cm, covered with an impervious tape and the torso was firmly secured with an elastic bandage. The dressing was left in place for 48 h. After 3 weeks of rest, the animals were subjected to challenge exposure. The flanks of the control and test animals were clipped, and occlusive patches of the test chemical and vehicle (control) were applied for 24 h. The test sites were evaluated for dermal reactions after 48 and 72 hours. Macroscopic examination of the animals showed erythema, edema and inflammation in 8 of the 20 guinea pigs. Microscopic evaluation showed acanthosis and massive layer of infiltration of the superficial layers of the derma with lymphomonuclears in 2 animals. These appearances showed positive showed of sensitization. Ambiguous reactions were observed in 4/20 animals. Based on the reactions observed, test chemical can be considered to be sensitizing to skin.

The results of GPMT test and various patch test indicate a possibility that test chemical could have a potential to cause sensitization to skin.

Hence, the test chemical can be considered to be weak sensitizer to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Available data for test chemical indicates that it is likely to induce dermal reactions. Hence,the test chemical can be considered to be sensitizing to skin.