[No public or meaningful name is available]

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

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

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

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

Test material information

Constituent 1

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

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

Results

Results 1

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.

Results 2

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.