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EC number: 270-315-8 | CAS number: 68424-66-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 28 February 1977 to 8 April 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- In a method comparable to the human repeat insult patch test (HRIPT), 53 human volunteers were used to test the irritation and sensitisation potential of the test material under conditions of a stringently supervised and monitored patch test. The test material was tested in concentrations of 20%, 40%, 60%, 80%, and 100%. Each fully occluded patch was applied for 24 hours.
The volunteers were divided into 5 groups and dosed as follows:
Group I - 11 Subjects - 60% in petrolatum.
Group II - 11 Subjects - 20% in petrolatum.
Group III - 11 Subjects - 100% as supplied.
Group IV - 11 Subjects - 80% in petrolatum.
Group V - 11 Subjects - 40% in petrolatum.
(2 subjects dropped out prior to the initiation of the study in groups III and V, leaving a total of 53 subjects during the remainder of the study).
The subjects were evalutated after 24 hours to determine skin irritation. Reactions were evaluated according to the following scale:
0 = No visible erythema
1 = Erythema
2 = Erythema plus swilling
3 = Erythema, swelling, plus papules
4= Severe irritation consisting of erythema, swelling, papules and necrosis and extension beyond the areas of contact.
The initial exposure determined the tollerance of the test subject to the concentration of the test material, and was evaluated for primary irritancy. - GLP compliance:
- no
- Remarks:
- Not applicable
Test material
- Reference substance name:
- Lanolin, hydroxylated
- EC Number:
- 270-315-8
- EC Name:
- Lanolin, hydroxylated
- Cas Number:
- 68424-66-8
- IUPAC Name:
- Lanolin, hydroxylated
- Test material form:
- solid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed:
- Age: 18 or over
- Known diseases: Absence of skin disease. General well-being. - Clinical history:
- Subjects were selected based on the absence of skin disease and general well being
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: Unchanged or in petrolatum
- Concentrations: 20%, 40%, 60%, 80%, and 100%
- Volume applied: 1 mL/cm²
- Testing/scoring schedule:
Induction:
The induction period included the initial primary irritancy exposure. The test material was applied via occlusive partch and remained in situ for 24 hours. the patch was removed and scroed. If no significant reaction was observed, the test material was re-applied to the same site for 24 hours. This procedure was performed 4 consecutive days a week (Monday through Thursday) for three weeks.
Challenge:
The test material was applied to a previously untested site after just over two weeks, and left in situ for 24 hours. the patch was removed and read for the immediate response. Follow-up readings were made at 24, 48 and 72 hours after removal of the patch.
EXAMINATIONS
- Grading/Scoring system:
0 = No visible erythema
1 = Erythema
2 = Erythema plus swilling
3 = Erythema, swelling, plus papules
4= Severe irritation consisting of erythema, swelling, papules and necrosis and extension beyond the areas of contact.
- Statistical analysis: Mainland D et al. (1956)Tables for Use with Binomial Samples, Department of Medical Statistics, New York University College of Medicine.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: Results of the first application indicate the test material was incapable of acting as a primary irritant in any of the individuals under test. The absence of any irritation as a result of Application Nos, 2 through 12 indicates the test material was incapable of acting as a fatiguing agent in any of the individuals under test. The absence of any irritation as a result of Application No. 13, Challenge, indicates the test material was incapable of sensitising any of the individuals under test.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0 %
- Number of subjects with negative reactions: 100 %
- Number of subjects with equivocal reactions: 0 %
- Number of subjects with irritating reactions: 0 %
Statistical considerations based on the number of the individuals participating (55), the numbers showing intolerance (0), and the degree of certainty. A prediction with 95 % certainty is paossible that at least 92.89 % of a general population will not be irritated or sensitised by this material.
Any other information on results incl. tables
Individual Reactions:
Subject |
Concentration |
Week 1 |
Week 2 |
Week 3 |
Challenge |
|||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
24 hours |
48 hours |
72 hours |
||
1 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
11 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
13 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
15 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
16 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
17 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
18 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
19 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
20% |
Dropped out |
||||||||||||||
23 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
26 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
27 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
28 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
29 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
31 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
32 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
33 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
34 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
35 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
36 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
37 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
38 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
39 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
40 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
41 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
42 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
43 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
44 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
45 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
46 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
47 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
49 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
50 |
40% |
Dropped out |
||||||||||||||
51 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
52 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
53 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
54 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
55 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Conclusions:
- No visible skin damage was observed in any of the individuals participating in this test. This evidence of apparent innocuousness enables the investigator to express an opinion that there is nothing in the results which could be construed to be a contraindication to the use of this material in a general human population.
- Executive summary:
53 human volunteers were used in the skin sensitization study with the test material applied occlusively between 20 - 100% concentration. No visible skin damage was observed in any of the individuals participating in this test. This evidence of apparent innocuousness enables the investigator to express an opinion that there is nothing in the results which could be construed to be a contraindication to the use of this material in a general human population.
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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