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EC number: 944-207-2 | CAS number: 2156592-65-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Adequacy of study:
- supporting study
- Study period:
- Between 04 March 1993 and 26 March 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles but criteria for subject selection was not described.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
- Type of study / information:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
Test material
- Details on test material:
- Total Base Number (TBN) = 300
Constituent 1
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- The 48-Hour Patch Test was conducted to determine comparative dermal irritation to determine tolerability for subsequent human patch testing as follows:
Panel No: 93030
The study was initiated on March 4,1993 and observations (skin reactivity) were made on March 6, 1993 (48-hours) and March 8, 1993 (96-hours).
Panel No: 93037
The study was initiated on March 22,1993 and observations (skin reactivity) were made on March
24, 1993 (48-hours) and March 26, 1993 (96-hours).
Approximately 0.2 mL of each test article was placed onto Parke-Davis Readi-Bandage occlusive patches. The patch test units were applied to the back of each subject for a period of 48-hours.
At the end of the 48-hour contact period, the patch test units were removed at the Clinic and scored for dermal reactivity. A second reading was taken 48-hours later (96-hour post-application).
Dermal responses were recorded using the following 6-point scale:
0 = No evidence of any effect
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema)
1 = Mild (Pink, uniform erythema covering most of the contact site)
2 = Moderate (Pink-red erythema uniform in the entire contact site)
3 = Marked (Bright-red erythema with/without petechiae or papules)
4 = Severe (Deep-red erythema with/without vesiculation or weeping)
All other observed dermal sequelae (Le. oedema, dryness, hypo- or hyperpigmentation, etc.) were appropriately recorded and described as mild, moderate or severe. - Exposure assessment:
- measured
- Details on exposure:
- Panel No: 93030
Twenty-seven (27) subjects, 8 males and 19 females, ranging in age from 18 to 67 years, were empaneled to test 1%, 3%, and 10% concentrations of the test articles, including 2 controls.
Panel No: 93037
Twenty-eight (28) subjects, 7 males and 21 females, ranging in age from 18 to 58 years, were empaneled to test 30% and 100% (Neat) concentrations of the test articles, without the controls.
The subjects were informed of the nature of the tests, including possible adverse reactions.
Written informed consent was obtained.
Additionally, the subjects were considered dependable and able to read and understand instructions. The subjects did not exhibit any physical or dermatological conditions which would have precluded application of the test articles.
The subjects did not exhibit any physical or dermatological conditions which would have precluded application of the test articles.
Results and discussion
- Results:
- A total of 27/27 subjects satisfactorily completed the test procedure for Panel no. 93030. A total of 28/28 subjects satisfactorily completed the test procedure for Panel no. 93037. There were no discontinued panellists at any time during the come of the studies.
None of the patch test reactivity observed was considered to be evidence of allergic contact sensitisation. All were considered indicative of irritation.
Peak levels of dermal irritation were observed at the 48-hour reading (i.e., following removal of the patch). By the 96-hour reading, overall levels and seventy of reactivity were generally diminished.
Student-Newman-Keuls post-hoc analyses showed the following significant (P 5.05) differences in mean irritation scores observed among all the concentrations tested.
Under the conditions of a 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles based on comparative mean irritation scores was observed: Calcium sulfonate C15-36 TBN=13 >= Calcium sulfonate TBN=13 >=Calcium sulfonate TBN=30 > Non-sulfonate substance >= Calcium sulfonate TBN=300 (EC# 263-093-9) = Calcium sulfonate TBN=300 = mineral oil = mineral oil.
Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitisation in human subjects.
Any other information on results incl. tables
Table 1 | |||||||||||
Individual Test Subject Irritation Scores | |||||||||||
Test Article: Calcium sulfonate TBN=13 | |||||||||||
48 hours | 96 hours | ||||||||||
Subj. No | Test concentration | Panel 93030 | Panel 93037 | Panel 93030 | Panel 93037 | ||||||
1% | 3% | 10% | 30% | 100% | 1% | 3% | 10% | 30% | 100% | ||
1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 2s | |
2 | 0 | + | 0 | 0 | 0 | 0 | + | 0 | 0 | 0 | |
3 | 0 | 0 | + | 3 | 3 | 0 | 0 | + | + | 1 | |
4 | 0 | 0 | + | 0 | 0 | 0 | 0 | + | 0 | 0 | |
5 | 0 | 0 | 1 | 0 | 3 | 0 | 0 | 1 | 0 | 1 | |
6 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | + | 2 | |
8 | 0 | 0 | + | 0 | 3 | 0 | 0 | + | 0 | 1 | |
9 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | |
10 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | + | 0 | 1 | |
11 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | + | + | 2 | |
12 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 2 | |
13 | 0 | 0 | + | 0 | 2 | 0 | 0 | 0 | 0 | 1 | |
14 | + | + | + | 1 | 3 | 0 | 0 | 0 | 1 | 3 | |
15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
17 | 0 | 0 | + | 0 | 2 | 0 | 0 | + | 0 | 1 | |
18 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 2 | 3 | |
19 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 2 | 3s | |
20 | 0 | 0 | 0 | + | 2 | 0 | 0 | 0 | 0 | 1 | |
21 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 3s | |
22 | 0 | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 2 | 2 | |
23 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 2 | 2 | |
24 | 0 | 0 | + | 2 | 2 | 0 | 0 | 0 | 2 | 2 | |
25 | 0 | 0 | + | 0 | 3 | 0* | 0* | +* | 0 | 3 | |
26 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2s | |
27 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | |
28 | - | - | - | 2 | 2 | - | - | - | 1 | 1 | |
Scale: | 0 = No evidence of any effect | ||||||||||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||||||||||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||||||||||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||||||||||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||||||||||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} | |||||||||||
* = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours | s = scabbing | ||||||||||
- = 27 subjects were empanelled for Panel No. 93030 | |||||||||||
- = 28 subjects were empanelled for Panel No. 93037 |
Table 2 | |||||||||||
Individual Test Subject Irritation Scores | |||||||||||
Test Article: Calcium sulfonate C15-36 TBN=13 | |||||||||||
48 hours | 96 hours | ||||||||||
Subj. No | Test concentration | Panel 93030 | Panel 93037 | Panel 93030 | Panel 93037 | ||||||
1% | 3% | 10% | 30% | 100% | 1% | 3% | 10% | 30% | 100% | ||
1 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | + | 1s | |
2 | 0 | 0 | 0 | 0 | 3 | 0 | + | 0 | 0 | 0 | |
3 | 0 | 0 | + | + | 2 | 0 | 0 | 0 | + | + | |
4 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 3 | |
5 | 0 | 0 | + | 0 | 3 | 0 | 0 | + | 0 | 2 | |
6 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 | 0 | 0 | + | 0 | 3 | 0 | 0 | 0 | 0 | 2 | |
8 | 0 | 0 | 0 | + | 3 | 0 | 0 | 0 | 0 | 3s | |
9 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 2 | |
10 | 0 | 0 | 1 | 0 | 3 | 0 | 0 | + | 0 | 3 | |
11 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | + | 0 | 3 | |
12 | 0 | 0 | + | 0 | 3 | 0 | 0 | 0 | 0 | 2 | |
13 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 3s | |
14 | 0 | 0 | + | 1 | 3 | 0 | 0 | 0 | 1 | 2 | |
15 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
17 | 0 | 0 | + | 0 | 3 | 0 | 0 | 0 | 0 | 3s | |
18 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 2 | |
19 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | + | 3s | |
20 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | |
21 | 0 | 0 | 1e | 0 | 3 | 0 | 0 | + | 0 | 3s | |
22 | 0 | + | 0 | 2 | 3 | 0 | 0 | 0 | + | 3 | |
23 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 2 | |
24 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | + | 2 | |
25 | 0 | 0 | 0 | 2 | + | 0* | 0* | 0* | 3s | + | |
26 | 0 | 0 | 0 | 2 | + | 0 | 0 | 0 | 2s | 0 | |
27 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 2 | |
28 | - | - | - | 0 | 3 | - | - | - | 0 | 3 | |
Scale: | 0 = No evidence of any effect | ||||||||||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||||||||||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||||||||||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||||||||||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||||||||||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} | |||||||||||
* = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours | s = scabbing | ||||||||||
- = 27 subjects were empanelled for Panel No. 93030 | |||||||||||
- = 28 subjects were empanelled for Panel No. 93037 |
Table 3 | |||||||||||
Individual Test Subject Irritation Scores | |||||||||||
Test Article: Calcium sulfonate TBN=300 | |||||||||||
48 hours | 96 hours | ||||||||||
Subj. No | Test concentration | Panel 93030 | Panel 93037 | Panel 93030 | Panel 93037 | ||||||
1% | 3% | 10% | 30% | 100% | 1% | 3% | 10% | 30% | 100% | ||
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | + | 0 | 0 | 0 | 0 | + | 0 | 0 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
14 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
15 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
21 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
23 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
25 | 0 | 0 | 0 | 0 | 0 | 0* | 0* | 0* | 0 | 0 | |
26 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
27 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
28 | - | - | - | 0 | 0 | - | - | - | 0 | 0 | |
Scale: | 0 = No evidence of any effect | ||||||||||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||||||||||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||||||||||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||||||||||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||||||||||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} | |||||||||||
* = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours | |||||||||||
- = 27 subjects were empanelled for Panel No. 93030 | |||||||||||
= 28 subjects were empanelled for Panel No. 93037 |
Table 4 | |||||||||||
Individual Test Subject Irritation Scores | |||||||||||
Test Article: Calcium sulfonate TBN=30 | |||||||||||
48 hours | 96 hours | ||||||||||
Subj. No | Test concentration | Panel 93030 | Panel 93037 | Panel 93030 | Panel 93037 | ||||||
1% | 3% | 10% | 30% | 100% | 1% | 3% | 10% | 30% | 100% | ||
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 1 | 0 | 0 | + | + | + | 0 | 0 | |
3 | 0 | + | 0 | 3 | 3 | 0 | 0 | 0 | 1 | 2 | |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
5 | 0 | 0 | 1 | 0 | + | 0 | 0 | + | 0 | + | |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 | 0 | 0 | + | 2 | 3 | 0 | 0 | 0 | 2s | 2s | |
8 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 3s | |
9 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | |
10 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | |
11 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 2 | |
12 | 0 | 0 | 1 | 2 | 3 | 0 | 0 | + | 1 | 2 | |
13 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | + | |
14 | 0 | 0 | + | 1 | 3 | 0 | 0 | 0 | 0 | 3 | |
15 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
16 | 0 | 0 | + | 0 | 0 | 0 | 0 | + | 0 | 0 | |
17 | 0 | + | + | 0 | 3 | 0 | 0 | 0 | 0 | 3s | |
18 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 2 | |
19 | 0 | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 3s | 3s | |
20 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | + | + | |
21 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 2 | 3s | |
22 | 0 | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 3s | 3s | |
23 | 0 | 0 | + | 0 | + | 0 | 0 | + | 0 | 0 | |
24 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | |
25 | 0 | 0 | + | 1 | 2 | 0* | 0* | 0* | + | + | |
26 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
27 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | + | |
28 | - | - | - | 0 | 0 | - | - | - | 0 | 0 | |
Scale: | 0 = No evidence of any effect | ||||||||||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||||||||||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||||||||||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||||||||||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||||||||||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} | |||||||||||
* = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours | |||||||||||
- = 27 subjects were empanelled for Panel No. 93030 | |||||||||||
= 28 subjects were empanelled for Panel No. 93037 |
Table 5 | |||||||||||
Individual Test Subject Irritation Scores | |||||||||||
Test Article: Calcium sulfonate TBN=300 (EC 263-093-9) | |||||||||||
48 hours | 96 hours | ||||||||||
Subj. No | Test concentration | Panel 93030 | Panel 93037 | Panel 93030 | Panel 93037 | ||||||
1% | 3% | 10% | 30% | 100% | 1% | 3% | 10% | 30% | 100% | ||
1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 2s | 0 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
8 | + | 0 | 0 | 0 | 0 | + | 0 | 0 | 0 | 0 | |
9 | 0 | 0 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | |
10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
14 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
21 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
23 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
25 | 0 | 0 | 0 | 0 | 0 | 0* | 0* | 0* | 0 | 0 | |
26 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
27 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
28 | - | - | - | 0 | 0 | - | - | - | 0 | 0 | |
Scale: | 0 = No evidence of any effect | ||||||||||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||||||||||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||||||||||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||||||||||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||||||||||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} | |||||||||||
* = Subject No. 25 missed the 96-hour readiung: Reading was taken at 120-hours | s = scabbing | ||||||||||
- = 27 subjects were empanelled for Panel No. 93030 | |||||||||||
= 28 subjects were empanelled for Panel No. 93037 |
Table 6 | |||||||||||
Individual Test Subject Irritation Scores | |||||||||||
Test Article: Non-sulfonate substance | |||||||||||
48 hours | 96 hours | ||||||||||
Subj. No | Test concentration | Panel 93030 | Panel 93037 | Panel 93030 | Panel 93037 | ||||||
1% | 3% | 10% | 30% | 100% | 1% | 3% | 10% | 30% | 100% | ||
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1s | |
2 | 0 | + | 1 | 0 | 0 | 0 | + | + | 0 | 0 | |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | + | + | |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
5 | 0 | 0 | + | + | + | 0 | 0 | + | 0 | 0 | |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
8 | 0 | 0 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | |
9 | 0 | 0 | 0 | + | + | 0 | 0 | 0 | 0 | 0 | |
10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
12 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
14 | + | + | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
15 | + | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
17 | 0 | 0 | 0 | 0 | + | 0 | 0 | 0 | 0 | 0 | |
18 | + | + | + | + | + | + | + | + | 0 | 0 | |
19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
21 | 0 | 0 | 0 | + | 1 | 0 | 0 | 0 | + | 1 | |
22 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | |
23 | 0 | 0 | 0 | 0 | + | 0 | 0 | 0 | 0 | + | |
24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
25 | + | 0 | 0 | 0 | + | 0* | 0* | 0* | 0 | 0 | |
26 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
27 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
28 | - | - | - | 0 | 0 | - | - | - | 0 | 0 | |
Scale: | 0 = No evidence of any effect | ||||||||||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||||||||||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||||||||||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||||||||||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||||||||||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} | |||||||||||
* = Subject No. 25 missed the 96-hour readiung: Reading was taken at 120-hours | s = scabbing | ||||||||||
- = 27 subjects were empanelled for Panel No. 93030 | |||||||||||
= 28 subjects were empanelled for Panel No. 93037 |
TABLE 7 | |||
Panel No: 93030 | |||
Individual Test Subject Irritation Scores | |||
Test Article: Mineral Oil | |||
Subject No. | 48 hours | 96 hours | |
Neat | Neat | ||
1 | 0 | 0 | |
2 | 0 | 0 | |
3 | 0 | 0 | |
4 | 0 | 0 | |
5 | + | + | |
6 | 0 | 0 | |
7 | 0 | 0 | |
8 | 0 | 0 | |
9 | 0 | 0 | |
10 | 0 | 0 | |
11 | 0 | 0 | |
12 | 0 | 0 | |
13 | 0 | 0 | |
14 | 0 | 0 | |
15 | 0 | 0 | |
16 | 0 | 0 | |
17 | 0 | 0 | |
18 | 0 | 0 | |
19 | 0 | 0 | |
20 | 0 | 0 | |
21 | 0 | 0 | |
22 | 0 | 0 | |
23 | 0 | 0 | |
24 | 0 | 0 | |
25 | + | +(120h=0) | |
26 | 0 | 0 | |
27 | 0 | 0 | |
Scale: | 0 = No evidence of any effect | ||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} | |||
* = missed visit, no reading taken |
TABLE 8 | |||
Panel No: 93030 | |||
Individual Test Subject Irritation Scores | |||
Test Article: Mineral Oil | |||
Subject No. | 48 hours | 96 hours | |
Neat | Neat | ||
1 | 0 | 0 | |
2 | 0 | 0 | |
3 | 0 | 0 | |
4 | 0 | 0 | |
5 | 0 | 0 | |
6 | 0 | 0 | |
7 | 0 | 0 | |
8 | 0 | 0 | |
9 | 0 | 0 | |
10 | 0 | 0 | |
11 | 0 | 0 | |
12 | + | 0 | |
13 | 0 | 0 | |
14 | 0 | 0 | |
15 | + | 0 | |
16 | 0 | 0 | |
17 | 0 | 0 | |
18 | 0 | 0 | |
19 | 0 | 0 | |
20 | 0 | 0 | |
21 | 0 | 0 | |
22 | 0 | 0 | |
23 | 0 | 0 | |
24 | 0 | 0 | |
25 | 0 | 0 | |
26 | 0 | 0 | |
27 | 0 | 0 | |
Scale: | 0 = No evidence of any effect | ||
+ = Barely Perceptible (Minimal, faint, uniform or spotty erythema | |||
1 = Mild (Pink, uniform erythema covering most of the contact site) | |||
2 = Moderate (Pink-red erythema uniform in the entire contact site) | |||
3 = Marked (Bright-red erythema with/without petechiae or papules) | |||
4 = Severe (Deep-red erythema with/without vesiculation or weeping} |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of a 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles based on comparative mean irritation scores was observed: Calcium sulfonate C15-36 TBN=13 >= Calcium sulfonate TBN=13 >= Calcium sulfonate TBN=30 > Non-sulfonate substance >= Calcium sulfonate TBN=300 (EC 263-093-9) = Calcium sulfonate TBN=300 = Mineral oil = Mineral oil.
Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitization in human subjects. - Executive summary:
To determine and compare the relative primary irritation potential and estimate tolerability for subsequent occlusive RIPT studies of eight (8) test articles when applied to the skin of human subjects for 48-hours under occlusive patches.
Under the conditions of a 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles based on mean irritation scores was observed: Calcium sulfonate C15-36 TBN=13 >= Calcium sulfonate TBN=13 >= Calcium sulfonate TBN=30 > Non-sulfonate substance >= Calcium sulfonate TBN=300 (EC 263-093-9) = Calcium sulfonate TBN=300 = Mineral oil = Mineral oil.
Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitization in human subjects.
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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