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EC number: 231-303-8 | CAS number: 7488-56-4
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From Feb. 26, 1990 to Jan. 30, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Please refer to Section 13.2 - Weight of Evidence Approach for the Assessment of Skin Sensitisation Potential of Selenium Disulphide, CAS 7488-56-4, EC 231-303-8
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From Feb. 28, 1990 to Jan. 30, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Please refer to Section 13.2 - Weight of Evidence Approach for the Assessment of Skin Sensitisation Potential of Selenium Disulphide, CAS 7488-56-4, EC 231-303-8
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- The objective of this study was to determine the absence of the test substance to cause sensitization by repeated occlusive topical applications to human skin. The test substance (0.15%) was applied to human subjects on upper part of arm for 24 hours at each of 9 consecutive applications. The subjects were challenged 12 days after the last induction patch application with same concentration of test substance for 24 hours. Individuals were observed for signs of irritation/sensitization 48 hours after patch application during induction phase and 48 and 96 hours after challenge applications. Subjects were also rechallenged with test substance, if a positive outcome was obtained in induction phase.
- GLP compliance:
- not specified
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 126 subjects and 110 completed the study
- Sex: Females and males
- Age: Female: 15 - 65+ and Male: 18 - 65+
- Demographic information: God's Bible School, Cincinnati, Ohio - Clinical history:
- - History of allergy or casuistics for study subject or populations: Detailed information is provided in the table 1 under "any other information on material and methods incl. tables section". In original study report, this data is represented on Appendix IV, page 14.
- Controls:
- None
- Route of administration:
- dermal
- Details on study design:
- ADMINISTRATION
- Description of patch: Webril pad (Diameter: 7/8 inch), reinforced with extra tape and coban elastic wrap was used to assure patch adherence
- Concentrations: 0.15% w/v G3099.01 w/v aqueous solutions for both induction and challenge
- Volume applied: 0.5 mL/patch
- Testing/scoring schedule: 48 hours after each of 9 induction patches and at 48 and 96 hours after the challenge patch application
- Removal of test substance: 24 hours after each of 9 induction patch and a challenge patch
EXAMINATIONS
- Grading/Scoring system:
0: No visible reaction (including superficial skin response such as glazing, peeling, cracking)
1: Mild erythematous reaction (faint pink to definite pink)
1E*: Mild erythematous reaction with papules and/or edema
2: Moderate erythematous reaction (definite pink to red erythema, similar to sunburn)
2E*: Moderate erythematous reaction with edema and/or papules
3: Strong erythematous reaction (beef red)
3E*: Strong erythematous reaction with marked edema, papules and/or few vesicles
4: Severe reaction with erythema, edema, papules and vesicles (may be evidence of weeping)
5: Bullous reaction
(S): Reaction spread beyond webril pad area
*Erythema, papules, edema and vesicles are judged to be present if they involve 25% or more of patch site. If papules are present append P to the grade i.e. EP. If vesicles are present, append a V to grade i.e EV.
- Statistical analysis: Not reported - Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
INDUCTION PHASE
After 9 induction patches,
-1/110 subjects showed positive response
CHALLENGE PHASE
No effect was observed.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1/110
- Number of subjects with negative reactions: 109/110 subjects
- Number of subjects with equivocal reactions: 0/110 subjects
- Number of subjects with irritating reactions: 0/110 subjects
There was no evidence of skin sensitization production in the 109 volunteer panelists who completed the test. One subject exhibited responses during induction that leads to further investigation. The panelist was rechallenged five months later using 0.15 and 0.015% formulation (G3099.01) and a distilled water control, there were no signs of sensitization. Detailed information is provided in the table 3 under "any other information on results incl. tables". In original study report, this data is represented on table III, page 26. - Conclusions:
- No sign of skin sensitization was observed in 110 subjects when exposed to H&S E conditioning version with 0.60% DMDM hydantoin (0.996% selenium disulfide) formulation.
- Executive summary:
The absence of the skin sensitization potential of H&S E conditioning version with 0.60% DMDM hydantoin (0.996% selenium disulfide) formulation was assessed in a human repeat insult patch study. A total of 126 subjects participated in the study. Subjects were exposed to 9 induction patches containing H&S E conditioning version with 0.60% DMDM hydantoin (0.996% selenium disulfide) on the upper part of arm. Patches were removed 24 hours each application and patch sites were graded at 48 hours after patch application prior to the next patch application. After 12 days rest period, subjects were challenged with the same concentration (24 hour patch exposure). Challenge patch sites were graded at 48 and 96 hours after patch application.
In this study, 110/126 subjects completed the study. A total 16 subjects dropped from the study. None of them showed sensitization reactions. These were dropped due to schedule conflicts (4 subjects), were out of town (4 subjects), forgot (3 subjects), non-test related hives (1 subject), non-test related rash (1 subject), needed to use medicine for eczema (1 subject), work schedule (1 subject) and didn't want to wear patch (1 subject).
There was no evidence of skin sensitization on 109 subjects who completed the test, although 1 subject exhibited responses during induction that warranted further investigation. On subsequent rechallenge after four months with 0.15 and 0.015% of formulation and a distilled water control, there were no signs of sensitization.
Under the study conditions, no sign of skin sensitization was observed in 110 subjects when exposed to H&S E conditioning version with 0.60% DMDM hydantoin (0.996% selenium disulfide) formulation.
Table 2: Reasons for failure to complete test (WTDS# 36097)
Subject No. | Date | Reason |
6 | 03-Mar-90 | Didn't want to wear patch |
18 | 14-Mar-90 | Out of town |
22 | 14-Mar-90 | Out of town |
27 | 19-Mar-90 | Out of town |
31 | 07-Mar-90 | Work schedule |
39 | 02-Apr-90 | Forgot |
48 | 02-Apr-90 | Forgot |
52 | 05-Mar-90 | Out of town |
70 | 07-Mar-90 | Rash: Not test related |
74 | 02-Mar-90 | Needed to use med. For eczema |
77 | 12-Mar-90 | Hives: Not test related |
93 | 07-Mar-90 | Schedule conflict |
101 | 05-Mar-90 | Schedule conflict |
110 | 03-Mar-90 | Schedule conflict |
124 | 07-Mar-90 | Schedule conflict |
126 | 02-Apr-90 | Forgot |
Table 3: Results of rechallenge of panelist #86 (WTDS#36097)
Rechallenge code | Test material | Scores (Hours after application) | |
48 hours | 72 hours | ||
O-1 | Conditioning version H&S E (0.60%) (0.15% C3099.01; 0.60% C0711.02) | 0 | 0 |
A-1 | 0 | 0 | |
O-2 | Distilled water control | 0 | 0 |
A-2 | 0 | 0 | |
O-3 | Conditioning version H&S E (0.60%) (0.15% C3099.01; 0.60% C0711.02) | 0 | 0 |
A-3 | 0 | 0 |
Patch date: 4-Sept-90
Scoring date: 6-Sept-90 and 7-Sept-90
O: Original induction arm (left)
A: Alternate arm (right)
Patching material: H&S E Conditioning Version BY0908. (G3099.01)
Patch Size: 7/8 inch and diameter: 0.5 mL/patch
Patches were reinforced with extra tape; Coban elastic wrap was used to assure patch adherence
Patches were worn for 24 hours and scored at 48 and 72 hours
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From May 11, 1987 to July 8, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Please refer to Section 13.2 - Weight of Evidence Approach for the Assessment of Skin Sensitisation Potential of Selenium Disulphide, CAS 7488-56-4, EC 231-303-8
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- The objective of this study was to confirm the absence of test substance to cause sensitization by repeated occlusive topical applications to human skin. The test substance was applied to human subject’s lengthwise midway between the shoulder and elbow, on the lateral surface of the arm for 24 hours at each of 9 consecutive applications. The subjects were challenged 10 days after the last induction patch application (14 days for make-up subjects) with same concentration of test substance for 24 hours. Individuals were observed for signs of irritation/sensitization 48 hours after patch application during induction phase (72 hours after a weekend) and 48 and 96 hours after challenge applications
- GLP compliance:
- not specified
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 135 subjects and 120 completed the study
- Sex: Males (41) and Females (94)
- Age: 19 - 79
- Demographic information: Calvary Lutheran and Southwood Lutheran Church, Lincoln, NE - Clinical history:
- - History of allergy or casuistics for study subject or populations: Detailed information is provided in the table 1 under "any other information on material and methods incl. tables section". In original study report, this data is represented on page 31.
- Controls:
- None
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Occlusive
- Description of patch: Webril non woven cotton pad (Diameter: 7/8 inch) were centrally fixed on 2 to 2 1/2 wide and 7 inches long strip of Blenderm surgical tape
- Vehicle / solvent: Distilled water
- Concentrations: 0.15% w/v aqueous solution for induction and challenge
- Volume applied: 0.5 mL
- Testing/scoring schedule: 48 hours (72 hours after a weekend) after each of 9 induction patches and 48 and 96 hours after challenge patch application
- Removal of test substance: 24 hours after each of 9 induction patch and a challenge patch
EXAMINATIONS
- Grading/Scoring system:
0: No visible reaction (including superficial skin response such as glazing, peeling, cracking)
1: Mild erythematous reaction (faint pink to definite pink)
1E: Mild erythematous reaction with papules and/or edema
2: Moderate erythematous reaction (definite pink to red erythema, similar to sunburn)
2E: Moderate erythematous reaction with edema and/or papules
3: Strong erythematous reaction (beef red)
3E: Strong erythematous reaction with marked edema, papules and/or few vesicles
4: Severe reaction with erythema, edema, papules and vesicles (may be evidence of weeping)
5: Bullous reaction
(S): Reaction spread beyond webril pad area
Erythema, papules, edema and vesicles are judged to be present if they involve 25% or more of patch site.
- Statistical analysis: Not reported - Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
INDUCTION PHASE
Detailed information is provided in table 2 under “any other information on results incl. tables section”. In original study report, this data is represented on page 27.
CHALLENGE PHASE:
At 48 hours: Out of 120 subjects who completed this study, 5 subjects at original site and one subject at alternate site showed mild erythema (score 1).
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 106/120
- Number of subjects with negative reactions: 14/120
- Number of subjects with equivocal reactions: 0/120
- Number of subjects with irritating reactions: 5/120 subjects showed mild erythema (grade 1) - Conclusions:
- No skin sensitization was observed in 120 subjects when exposed to H&S E N/Dry with 0.5% menthol (1.004% selenium disulfide) formulation.
- Executive summary:
The absence of a skin sensitization potential of H&S E N/Dry with 0.5% menthol (1.004% selenium disulfide) formulation was assessed in a human repeat insult patch study. A total of 135 subjects participated in the study. Subjects were exposed to 9 induction patches containing 0.15% w/v H&S E N/Dry with 0.5% menthol (1.004% selenium disulfide) formulation on the lateral surface of arm. Patches were removed 24 hours each application and patch sites were graded at 48 hours after patch application prior to the next patch application. After 10 days rest period, subjects were challenged with the same concentration (24 hour patch exposure). Challenge patch sites were graded at 48 and 96 hours after patch application.
In this study, 120/135 subjects completed the study. A total 15 subjects dropped from the study and 5 subjects out of these showed mild erythema (score 1) at the time of dropout. These were dropped due to work schedule conflicts (2 subjects), were out of town (3 subjects), forgot (2 subjects), non-test related hospitalization/illness (3 subjects), death in family (1 subject), wanted to swim daily (1 subject), conflict with number of required visits (1 subject), unable to locate (1 subject) and didn't wished to continue (1 subject).
There was no evidence of skin sensitization in 120 subjects who completed the test, although 106/120 subjects showed at least one positive reaction.
Under the study conditions, no sign of skin sensitization was observed in 120 subjects when exposed to H&S E N/Dry with 0.5% menthol (1.004% selenium disulfide) formulation.
Table 2: Summary of grading score by visit
Grading Score | Induction grading visits | Challenge visit | ||||||||||||
1 | 2 | |||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | MU | Original | Alternate | Original | Alternate | |
0 | 102 | 62 | 77 | 62 | 42 | 82 | 61 | 52 | 49 | 18 | 115 | 119 | 120 | 120 |
1 | 16 | 56 | 47 | 58 | 75 | 40 | 54 | 67 | 67 | 31 | 5 | 1 | 0 | 0 |
1E | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 3: List of dropouts from study
Total dropouts: 15
Subjects Number | Number of exposures | Reason | Reaction at time of dropout |
16 | 9 | Forgot | 1 |
23 | 2 | Hospitalized : unrelated to study | 0 |
32 | 6 | Work schedule conflict | 1 |
35 | 9 | Out of town | 1 |
61 | 9 | Out of town | 0 |
67 | 1 | Out of town | Unknown: no grading |
74 | 1 | Wants to swim daily | Unknown: no grading |
75 | 1 | Illness: unrelated to study | Unknown: no grading |
95 | 3 | Conflict with number of visits required | 0 |
100 | 1 | Unable to locate | Unknown: no grading |
106 | 1 | Does not wish to contine | Unknown: no grading |
111 | 3 | Forgot | 0 |
113 | 1 | Illness: unrelated to study | Unknown: no grading |
122 | 4 | Death in family | 1 |
126 | 10 | Work schedule conflict: no challenge grades | 1 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- The objective of this study was to confirm the absence of test substance to cause sensitization by repeated occlusive topical applications to human skin. The test substance (0.15%) was applied to human subjects on upper part of arm for 24 hours at each of 9 consecutive applications. The subjects were challenged 12 days after the last induction patch application with same concentration of test substance for 24 hours. Individuals were observed for signs of irritation/sensitization 48 hours after patch application during induction phase and 48 and 96 hours after challenge applications. Subjects were also rechallenged with test substance, if a positive outcome was obtained in induction phase.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Selenium disulphide
- EC Number:
- 231-303-8
- EC Name:
- Selenium disulphide
- Cas Number:
- 7488-56-4
- Molecular formula:
- S2Se
- IUPAC Name:
- selenium disulphide
- Test material form:
- liquid
- Details on test material:
- - Name of test material: H&S E Conditioning version with 0.75% DMDM Hydantoin
- TSIN: G3098.01
- Physical form: Liquid
- Color: Peach
- pH: 5.40
- Storage conditions: Room temperature
- Expiry date: Feb. 01, 1991
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 125 subjects and 115 completed the study
- Sex: Females and males
- Age: Female: 18 - 65+ and Male: 18 - 54
- Demographic information: Northwest High School PTS, Cincinnati, Ohio - Clinical history:
- - History of allergy or casuistics for study subject or populations: Detailed information is provided in the table 1 under "any other information on material and methods incl. tables section". In original study report, this data is represented on Appendix IV, page 44.
- Controls:
- None
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Description of patch: Webril pad (Diameter: 7/8 inch), reinforced with extra tape and coban elastic wrap was used to assure patch adherence
- Concentrations: 0.15% w/v G3098.01 w/v aqueous solutions for both induction and challenge
- Volume applied: 0.5 mL/patch
- Testing/scoring schedule: 48 hours after each of 9 induction patches and at 48 and 96 hours after the challenge patch application
- Removal of test substance: 24 hours after each of 9 induction patch and a challenge patch
EXAMINATIONS
- Grading/Scoring system:
0: No visible reaction (including superficial skin response such as glazing, peeling, cracking)
1: Mild erythematous reaction (faint pink to definite pink)
1E*: Mild erythematous reaction with papules and/or edema
2: Moderate erythematous reaction (definite pink to red erythema, similar to sunburn)
2E*: Moderate erythematous reaction with edema and/or papules
3: Strong erythematous reaction (beef red)
3E*: Strong erythematous reaction with marked edema, papules and/or few vesicles
4: Severe reaction with erythema, edema, papules and vesicles (may be evidence of weeping)
5: Bullous reaction
(S): Reaction spread beyond webril pad area
*Erythema, papules, edema and vesicles are judged to be present if they involve 25% or more of patch site. If papules are present append P to the grade i.e. EP. If vesicles are present, append a V to grade i.e EV.
- Statistical analysis: Not reported
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
INDUCTION AND CHALLENGE PHASE
After 9 induction patches,
-1/115 subjects showed positive response
CHALLENGE PHASE
At 96 hours: Only 1/115 showed positive response
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1/115 subjects
- Number of subjects with negative reactions: 114/115 subjects
- Number of subjects with equivocal reactions: 0/115 subjects
- Number of subjects with irritating reactions: 0/115 subjects
There was no evidence of skin sensitization production in the 114 volunteer panelists who completed the test. Two subjects and exhibited responses during induction that warranted further investigation. The panelists were rechallenged four months later with using 0.15 and 0.015% formulation (G3098.01) and a distilled water control, there were no signs of sensitization. Detailed information is provided in the table 3 under "any other information on results incl. tables". In original study report, this data is represented on table III, page 55.
Any other information on results incl. tables
Table 2: Reasons for failure to complete test (WTDS# 36096)
Subject No. | Date | Reason |
5 | 07-Mar-90 | Jury duty |
16 | 19-Mar-90 | Forgot |
33 | 04-Apr-90 | In hospital (Not test related) |
44 | 02-Mar-90 | Schedule conflict |
47 | 19-Mar-90 | Sick (Not test related) |
53 | 02-Mar-90 | Sick (Not test related) |
67 | 02-Mar-90 | Got a job |
117 | 09-Mar-90 | Sick (Not test related) |
123 | 09-Apr-90 | Out of town |
125 | 19-Mar-90 | Forgot |
Table 3: Results of rechallange of Panelist #16 and #74 (WTDS# 36096)
Rechallenge code | Test material | Scores (Hours after application) | |||
Panelist #16 | Panelist #74 | ||||
48 hours | 72 hours | 48 hours | 72 hours | ||
O-1 | Conditioning H&S E version (0.15% C3098.01; 0.75% C0711.02) | 0 | 0 | 0 | 0 |
A-1 | 0 | 0 | 0 | 0 | |
O-2 | Distilled water control | 0 | 0 | 0 | 0 |
A-2 | 0 | 0 | 0 | 0 | |
O-3 | Conditioning version H&S E (0.015% C3098.01; 0.075% C0711.02) | 0 | 0 | 0 | 0 |
A-3 | 0 | 0 | 0 | 0 |
Patch date: 6-Aug-90
Scoring date: 8-Aug-90 and 10-Aug-90
O: Original induction arm (left)
A: Alternate arm (right)
Patching material: H&S E Conditioning Version BY0908. G3098.01
Patch Size: 7/8 inch and diameter: 0.5 mL/patch
Patches were reinforced with extra tape; Coban elastic wrap was used to assure patch adherence
Patches were worn for 24 hours and scored at 48 and 72 hours
Applicant's summary and conclusion
- Conclusions:
- No sign of skin sensitization was observed in 115 subjects when exposed to a H&S E conditioning version with 0.75% DMDM Hydantoin (0.998% selenium disulfide) formulation.
- Executive summary:
The absence of a skin sensitization potential of H&S E conditioning version with 0.75% DMDM Hydantoin (0.998% selenium disulfide) formulation was assessed in a human repeat insult patch study. A total of 125 subjects participated in the study. Subjects were exposed to 9 induction patches containing 0.15% w/v H&S E conditioning version with 0.75% DMDM Hydantoin (0.998% selenium disulfide) formulation on the upper part of arm. Patches were removed 24 hours each application and patch sites were graded at 48 hours after patch application prior to the next patch application. After a 12 days rest period, subjects were challenged with the same concentration (24 hour patch exposure). Challenge patch sites were graded at 48 and 96 hours after patch application.
In this study, 115/125 subjects completed the study. A total 10 subjects were dropped from the study. One of them showed positive reactions. These were dropped due to jury duty (1 subject), forgot (2 subjects), in hospital (not test related; 1 subject), schedule conflict (1 subject), sick (3 subjects; not test related), got a job (1 subject) and out of town (1 subject).
There was no evidence of skin sensitization on 114 subjects who completed the test, although 2 subjects, #16 (a drop from the study) and #74 exhibited responses during induction that warranted further investigation. On subsequent rechallenge after four months with 0.15 and 0.015% formulation and a distilled water control, there were no signs of sensitization.
Under the study conditions, no sign of skin sensitization was observed in 115 subjects when exposed to H&S E conditioning version with 0.75% DMDM Hydantoin (0.998% selenium disulfide) formulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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