Reaction mass of aluminium chloride, iron dichloride, magnesium chloride and manganese dichloride

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1987-03-16 to 1987-04-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted in accordance with Good Clinical Practices Regulations.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Type of sensitisation studied:

skin

Test guideline

Qualifier:

according to guideline

Guideline:

other: Good clinical practices tentative guideline

Deviations:

not applicable

Principles of method if other than guideline:

According to proposed good clinical practices guideline. Informed consents were given to subjects. Institutional review board reviewed the general protocol for this study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen chloride

EC Number:

231-595-7

EC Name:

Hydrogen chloride

Cas Number:

7647-01-0

Molecular formula:

HCl

IUPAC Name:

Hydrogen chloride

Details on test material:

- Name of test material (as cited in study report): Hydrogen chloride in water
- Molecular formula (if other than submission substance): HCl
- Molecular weight (if other than submission substance): Not available
- Substance type: Pure active substance
- Physical state: liquid
- Analytical purity: See below
- Impurities (identity and concentrations): See below
- Composition of test material, percentage of components: See below
- Isomers composition: See below
- Purity test date: See below
- Lot/batch No.: See below
- Expiration date of the lot/batch: See below
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: PH-3.8; TSIN B1150.01

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 128 subjects and 119 completed the study
- Sex: males and females
- Age: 19-72 years
- Race: predominantly Caucasian
- Demographic information: Not available
- Other: None

Clinical history:

- History of allergy or casuistics for study subject or populations: yes , see below
- Symptoms, onset and progress of the disease: Not available
- Exposure history: None known
- Aggravating factors both in home and workplace: None known
- Family history: Not available
- Medical history (for respiratory hypersensitivity):
- Any other allergic or airway disorders: Not available
- Smoking history: Not available
- Other: None

Controls:

None

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test) ; prick test; RAST; other immunological tests: patch test (epicutaneous test)


ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: occlusive
- Description of patch: 2-1/2 inch wide strip of Blenderm surgical tape approximately 7 inches long to which 7/8 inch diameter Webril nonwoven cotton discs are centrally fixed 3/4 inches apart.
- Vehicle / solvent: None
- Concentrations: Undiluted Hydrogen chloride in water
- Volume applied: 0.5 ml
- Testing/scoring schedule: 48 hours after each of the 9 induction patches and at 48 and 96 hours after the challenge patch application.
- Removal of test substance: 24 hours after each of the 9 induction patches and 24 hours after the challenge patch.
- Other: None


EXAMINATIONS
- Grading/Scoring system: 0=no visible reaction,1= mild erythema, 1E = mild erythema with papules and/or edema, 2=Definite pink to red erythema, 2E= moderate erythema with edema and/or papules, 3= strong erythema, 3E= strong erythema with marked edema, papular and/or few vesicles, 4= severe reaction with erythema, edema, papules and vesicles, 5= bullous reaction, S= reaction spread beyond webril pad area.
- Statistical analysis: None
- Other: None

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Treatment sites were observed 48 hours after patching on a Monday, Wednesday, Friday regimen for 3 weeks for nine induction exposures. A total of 31/119 subjects completing the study had mild erythema (grade 1).After 2 weeks, treatment sites were challenged and observed at 48 and 96 hours after patch application. A total of 8/119 subjects completing the study had mild erythema (grade 1). No response indicative of skin sensitization was observed.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/119
- Number of subjects with negative reactions: 119/119
- Number of subjects with equivocal reactions: 0/119
- Number of subjects with irritating reactions: 8/119 exhibited mild skin irritation (grade 1) during challenge.


RESULT OF CASE REPORT: Not available


OTHER RESULTS: None

Any other information on results incl. tables

Clinical history of subjects - Pre study Allergies and Sensitivities

Subject number	Pre study allergies and sensitivities
4	Milk
9	All cosmetics,all perfumed creams and lotions, yeast, peenuts, milk, steroid medicines
10,14,18,21,23,44,47,72,82,90,93,103,110,116,121	Poison ivy/poison oak
13	Avon skin cream and lotions, poison ivy and poison oak
16	Lactose
19	Old spice stick, antiperspirant / deodorant
24	Wool
25	Plant polien
26	Psoriasis, penicillin, can use only jewelry / metals, bee sting
28	Godeine
29,58,60,66,84,85	Penicillin
34	Exema
41	Poison ivy / poison oak, hypoallergent earring posts
43,122	Wool, poison ivy / poison oak
45	Ivory bar soap
48	Can use only Max Factor cosmetics and skin creams, poison ivy/poison oak
54	Can use only AImay cosmetics, poison ivy/poison oak
59	Dairy products
61	Insect stings
62	Avon perfumes, poison ivy/poison oak, penicillin
64	All Avon-cosmetics, perfumes,creams/lotions
69	Raintres lotion, jewelry and pierced earrings
71	Irish spring bar soap, wool
73	Poison ivy / poison oak, dairy products
81	Exema, iodine
83	Avon liquid make up, penicillin, jewelry
87	Avon mascara
88	Exema,all powder detergents, antiperspirants, coffee, yeast, pork, potatoes, dust molds
91	Molds, dust, feathers,
92	Revon and Covergirl cosmetics, jergens skin creams and lotions
97,99	Inexpensive earrings
98	Food with sulfur substance added, nickel
100	Quibron
107	Joy dishwashing liquid, Mary Kay cosmetics, Tickle antiperspirant
111	Motphine
112	Hog dust
113	Dairy food, penicillin
114	Black walnuts, gold, weeds, dust
117	Caress bar soap, compazine
118	Aspirin
124	Demerol, surf industry detergent, eggs, penicillin, Jergans creams
128	Tape

Applicant's summary and conclusion

Conclusions:

Hydrogen chloride in water (B1150.01) did not produce skin sensitization in human.

Executive summary:

The skin sensitization potential of Hydrogen chloride in water (B1150.01) was assessed in a human repeat patch study. A total of 128 subjects participeted in the study. Subjects were exposed to 9 induction patches containing 0.5 ml Hydrogen chloride in water (B1150.01) under occlusion on a Monday, Wednesday and Friday schedule for a period of 3 weeks. Patches were removed 24 hours after each application and patch sites were graded at 48 hours after patch application prior to the next patch application. After 2 week rest period, subjects were challenged with 0.5 ml Hydrogen chloride in water (B1150.01) (24 hour patch exposure). Challenge patch sites were graded at 48 and 96 hours after patch application.

In this study, 119/128 subjects completed the study. A total of 9 subjects were dropped. Two subjects were dropped because they could not contact, five were out of town, while one other subject has started steroid medication and one forgot to attend the test.

No positive response indicative of skin sensitization was observed.

Hydrogen chloride in water (B1150.01) did not produce skin sensitization in human.