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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987-03-16 to 1987-04-24
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accordance with Good Clinical Practices Regulations.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of sensitisation studied:
Test guideline
according to guideline
other: Good clinical practices tentative guideline
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:

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen chloride
EC Number:
EC Name:
Hydrogen chloride
Cas Number:
Molecular formula:
Cl H
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


Type of population:
Ethical approval:
confirmed and informed consent free of coercion received
- 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
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test) ; prick test; RAST; other immunological tests: patch test (epicutaneous test)

- 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

- 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:
- 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.

- 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.



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

Hydrogen chloride in water 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.