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Diss Factsheets
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EC number: 701-325-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- 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
- 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
Constituent 1
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.
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