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EC number: - | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 25 - August 29, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- July 25 - August 29, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, The Association of Food and Drug Officials (1965).
- Principles of method if other than guideline:
- - Principle of test: 106 people were exposed to the test substance nine times. 0.2 g of test substance was placed on an occlusive patch. The patches were worn for 24 hrs and applied 3 times per week for 3 weeks. Reactions were scored right before the next application. A 10 to 14 day rest period was then given to the subjects, after which they received the challenge dose to a site previously unexposed. The reactions were then scored 24 and 48 hrs later.
- Short description of test conditions: Test subjects were allowed to go home after the occlusive patches were applied.
- Parameters analysed / observed: Edema and erythema - GLP compliance:
- no
- Remarks:
- This study was not an OECD Guideline study. Rather it was done to determine the sensitization potential in humans, which is not the type of study performed by labs who have gone through he GLP compliance process.
- Species:
- other: Human
- Strain:
- other: Caucasian: 65, Hispanic: 17, African-American: 17, Asian: 7
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 109 people were enrolled in the study. Out of the 109, 106 completed the study. 32 males and 74
females took part in the study. The following were grounds for exclusion from the study: lactating or pregnant females, those on medications that could interfere with the study results, those under 18 years of age, those with chronic skin allergies, and those with medical conditions that could interfere with the results of the study. The participants were instructed to bathe before coming to the facility for dosing. Participants had an occlusive patch containing 0.2 g of test substance applied to their backs for 24 hrs. Participants went to the study facility for application, but removed the patches themselves 24 hrs later. Observation for edema and erythema were taken before the next application. Participants were dosed 9 times, 3 times a week (on Mondays, Wednesdays, and Fridays) for three consecutive weeks. Participants were then given a rest period of 10-14 days, and then given a challenge dose. The challenge dose consisted of another application of 0.2 g to an occlusive patch applied to a previously unexposed site. Reactions to the challenge dose were scored at 24 and 48 hrs after application. - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.2 g
- Day(s)/duration:
- 9 days of exposure 3 times per week for 3 weeks
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.2 g
- Day(s)/duration:
- Day 10
- No. of animals per dose:
- 106
- Details on study design:
- Test Site
-Area of exposure: Back
Removal of Test Substance
-Washing: yes
-Time after start of exposure: Participants removed the patches themselves after 24 hrs exposure.
Observation Time Points
Participants were observed when they came in for their next exposure, which was on Mondays, Wednesdays, and Fridays for three consecutive weeks.
Scoring System:
-Method of calculation: Reactions were scored on a scale of 0 to 4 for edema and erythema, with 0 being no reaction, and 4 being a severe reaction (deep red with vesiculation or weeping). - Challenge controls:
- None
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g
- No. with + reactions:
- 0
- Total no. in group:
- 106
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g
- No. with + reactions:
- 0
- Total no. in group:
- 106
- Clinical observations:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not sensitizing to skin.
- Executive summary:
106 people were exposed to the test substance nine times. 0.2 g of test substance was placed on an occlusive patch. The patches were worn for 24 hrs, and applied 3 times per week for 3 weeks. Reactions were scored right before the next application. A 10 to 14 day rest period was then given to the subjects, after which they received the challenge dose to a site previously unexposed. The reactions were then scored 24 and 48 hrs later. There were no adverse reactions during the study during either the induction or challenge phases. The test substance is therefore not sensitizing to skin.
Number | Challenge | Score |
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 | 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 | 0 | 0 |
26 | 0 | 0 |
27 | 0 | 0 |
28 | Discontinued | Discontinued |
29 | 0 | 0 |
30 | 0 | 0 |
31 | Discontinued | Discontinued |
32 | 0 | 0 |
33 | 0 | 0 |
34 | 0 | 0 |
35 | 0 | 0 |
36 | 0 | 0 |
37 | 0 | 0 |
38 | 0 | 0 |
39 | 0 | 0 |
40 | 0 | 0 |
41 | 0 | 0 |
42 | 0 | 0 |
43 | 0 | 0 |
44 | 0 | 0 |
45 | 0 | 0 |
46 | 0 | 0 |
47 | 0 | 0 |
48 | 0 | 0 |
49 | 0 | 0 |
50 | Discontinued | Discontinued |
51 | 0 | 0 |
52 | 0 | 0 |
53 | 0 | 0 |
54 | 0 | 0 |
55 | 0 | 0 |
56 | 0 | 0 |
57 | 0 | 0 |
58 | 0 | 0 |
59 | 0 | 0 |
60 | 0 | 0 |
61 | 0 | 0 |
62 | 0 | 0 |
63 | 0 | 0 |
64 | 0 | 0 |
65 | 0 | 0 |
66 | 0 | 0 |
67 | 0 | 0 |
68 | 0 | 0 |
69 | 0 | 0 |
70 | 0 | 0 |
71 | 0 | 0 |
72 | 0 | 0 |
73 | 0 | 0 |
74 | 0 | 0 |
75 | 0 | 0 |
76 | 0 | 0 |
77 | 0 | 0 |
78 | 0 | 0 |
79 | 0 | 0 |
80 | 0 | 0 |
81 | 0 | 0 |
82 | 0 | 0 |
83 | 0 | 0 |
84 | 0 | 0 |
85 | 0 | 0 |
86 | 0 | 0 |
87 | 0 | 0 |
88 | 0 | 0 |
89 | 0 | 0 |
90 | 0 | 0 |
91 | 0 | 0 |
92 | 0 | 0 |
93 | 0 | 0 |
94 | 0 | 0 |
95 | 0 | 0 |
96 | 0 | 0 |
97 | 0 | 0 |
98 | 0 | 0 |
99 | 0 | 0 |
100 | 0 | 0 |
101 | 0 | 0 |
102 | 0 | 0 |
103 | 0 | 0 |
104 | 0 | 0 |
105 | 0 | 0 |
106 | 0 | 0 |
107 | 0 | 0 |
108 | 0 | 0 |
109 | 0 | 0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, The Association of Food and Drug Officials (1965).
- Principles of method if other than guideline:
- - Principle of test: 106 people were exposed to the test substance nine times. 0.2 g of test substance was placed on an occlusive patch. The patches were worn for 24 hrs, and applied 3 times per week for 3 weeks. Reactions were scored right before the next application.
- Short description of test conditions: Test subjects were allowed to go home after the occlusive patches were applied.
- Parameters analysed / observed: Edema and erythema - GLP compliance:
- no
- Remarks:
- This study was not an OECD Guideline study. Rather, it was done to determine the sensitization potential in humans, which is not the type of study performed by labs who have gone through the GLP compliance process.
Test material
- Reference substance name:
- 6-Hydroxy-2,6-dimethylheptan-1-al
- Cas Number:
- 62439-42-3
- Molecular formula:
- C9H18O2
- IUPAC Name:
- 6-Hydroxy-2,6-dimethylheptan-1-al
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- other: Human
- Strain:
- other: Caucasian: 65, Hispanic: 17, African-American: 17, Asian: 7
- Details on test animals or test system and environmental conditions:
- 109 people were enrolled in the study. Out of the 109, 106 completed the study. 32 males and 74 females took part in the study. The following were grounds for exclusion from the study: lactating or pregnant females, those on medications that could interfere with the study results, those under 18 years of age, those with chronic skin allergies, and those with medical conditions that could interfere with the results of the study. The participants were instructed to bathe before coming to the facility for dosing. Participants had an occlusive patch containing 0.2 g of test substance applied to their backs for 24 hrs. Participants went to the study facility for application, but removed the patches themselves 24 hrs later. Observation for edema and erythema were taken before the next application. Participants were dosed 9 times, 3 times a week (on Mondays, Wednesdays, and Fridays) for three consecutive weeks.
Test system
- Type of coverage:
- occlusive
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 g - Duration of treatment / exposure:
- 9 (3 times per week for 3 weeks)
- Observation period:
- Three weeks. As this was also a dermal sensitization study, the participants were additionally monitored at 10 to 14 days after last induction exposure when they were given their challenge dose, and when they were monitored to their reactions to the challenge dose at 24 and 48 hrs after exposure.
- Number of animals:
- 106
- Details on study design:
- TEST SITE
- Area of exposure: Back
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: Participants removed the patches themselves after 24 hrs exposure.
OBSERVATION TIME POINTS
Participants were observed when they came in for their next exposure, which was on Mondays, Wednesdays, and Fridays for three consecutive weeks.
SCORING SYSTEM:
- Method of calculation: Reactions were scored on a scale of 0 to 4 for edema and erythema, with 0 being no reaction, and 4 being a severe reaction (deep red with vesiculation or weeping).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: Time point given corresponds with time point in study. Study did not follow typical 24, 48, and 72 hr observations. See table below for full results.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: Time point given corresponds with time point in study. Study did not follow typical 24, 48, and 72 hr observations. See table below for full results.
Any other information on results incl. tables
Number | Dermal Score Observation 1 | Dermal Score Observation 2 | Dermal Score Observation 3 | Dermal Score Observation 4 | Dermal Score Observation 5 | Dermal Score Observation 6 | Dermal Score Observation 7 | Dermal Score Observation 8 | Dermal Score Observation 9 |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 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 | 0 |
10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
11 | 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 |
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 |
17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
21 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
22 | 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 |
25 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
26 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
27 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
28 | 0 | 0 | 0 | Discontinued | Discontinued | Discontinued | Discontinued | Discontinued | Discontinued |
29 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
31 | 0 | 0 | 0 | 0 | Discontinued | Discontinued | Discontinued | Discontinued | Discontinued |
32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
33 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
34 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
35 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
36 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
37 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
38 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
39 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
40 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
42 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
43 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
44 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
45 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
46 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
47 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
48 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
49 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 0 | 0 | 0 | 0 | Discontinued | Discontinued | Discontinued | Discontinued | Discontinued |
51 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
52 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
53 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
54 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
55 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
56 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
57 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
58 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
59 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
60 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
61 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
62 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
63 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
64 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
65 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
66 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
67 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
68 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
69 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
70 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
71 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
73 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
74 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
75 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
76 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
77 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
78 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
79 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
80 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
81 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
82 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
83 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
84 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
85 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
86 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
87 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
88 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
89 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
90 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
91 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
92 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
93 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
94 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
95 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
96 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
97 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
98 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
99 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
101 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
102 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
103 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
104 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
105 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
106 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
107 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
108 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
109 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating to skin.
- Executive summary:
106 people were exposed to the test substance nine times. 0.2 g of test substance was placed on an occlusive patch. The patches were worn for 24 hrs and applied 3 times per week for 3 weeks. Reactions were scored right before the next application. A 10 to 14 day rest period was then given to the subjects, after which they received the challenge dose to a site previously unexposed. The reactions were then scored 24 and 48 hrs later. There were no adverse reactions during the study during either the induction or challenge phases. The test substance is therefore not irritating to skin.
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