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EC number: 262-979-2 | CAS number: 61788-48-5
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 1976 to 26 November 1976
- Reliability:
- 1 (reliable without restriction)
- 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:
- 1 976
- Report date:
- 1976
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- To determine the irritation and sensitisation potential of the test material, a human repeat insult patch test was performed in 53 human volunteers. The test material was applied via occlusive patch at a dosing rate of 0.1 mL/cm². To determine a suitable dosing regimen, the volunteers were dosed in groups of 10 (minimum) with the following concentrations in petrolatum, 100 %, 80%, 60 %, 40 % and 20 % (titration skin tolerance). The test material was found to be well tolerated, therefore after the first week of induction exposures a single exposure concentration of 100 % was selected for the remained of the study.
Patches were applied Monday through Thursday for 3 weeks, with observations performed after each patch removal. The patch site was rested over the weekend and dosing recommenced the following Monday. A total of 12 inductions applications were administered. On day 36 (just over 2 weeks after the induction exposures), the test material was challenge application was administered as a single exposure at 100 % for 24 hours. The test site was then read at patch removal for immediate response, then again at 24, 48 and 72 hours to determine skin reactions. - GLP compliance:
- no
- Remarks:
- Not applicable
Test material
- Reference substance name:
- Lanolin, acetate
- EC Number:
- 262-979-2
- EC Name:
- Lanolin, acetate
- Cas Number:
- 61788-48-5
- Molecular formula:
- Variable
- IUPAC Name:
- Lanolin, Acetates
- Test material form:
- solid
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 53 (56 volunteers were selected and individuals 5, 8 and 43 dropped out prior to study initiation).
- Age: Over the age of 18
- History of allergy or casuistics for study subject or populations: Volunteers were selected based on general well-being and absence of skin disease. - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: Petrolatum (skin irritation titration during the first week of inductions)
- Concentrations: 20, 40, 60, 80 and 100 % during the first week of induction exposures (skin titration for irritation tolerance). All other applications were performed at 100 %.
- Volume applied: 0.1 mL/cm²
- Testing/scoring schedule:
Induction: A total of 12 induction applications were performed. The test site was examined after each patch removal. If the reaction was not substantial (a score not in excess of 1), then the test material was re-applied to the same site).
Week 1, skin titration was performed, volunteers were split into 5 groups. Patches were applied Monday through Thursday. The test material patches remained in situ for 24 hours, and renewed after scoring at the end of each 24 hour period. On Friday, the patch was removed and the site scored. The skin was then allowed to rest over the weekend.
Volunteers 1-10 were dosed with neat material
Volunteers 11-19 were dosed with 40 % test material in petrolatum
Volunteers 20-31 were dosed with 80 % test material in petrolatum
Volunteers 32-43 were dosed with 20 % test material in petrolatum
Volunteers 44-56 were dosed with 60 % test material in petrolatum
Weeks 2 and 3, after the test material was found to be well tolerated, all subjects were dosed with the neat test material (100 %). Patches were applied Monday through Thursday. The test material patches remained in situ for 24 hours, and renewed after scoring at the end of each 24 hour period. On Friday, the patch was removed and the site scored. At the end of the second week the test site was allowed to rest over the weekend before commencing again on week 3.
In the event of a significant response at the test site (Score greater than 2), the study director could, at his discretion, elect to apply the patch at a fresh test site.
Challenge exposure: On day 36 (slightly more than 2 weeks after the last induction exposure), the test material (100 %) was applied to a new test site and left in situ for 24 hours. - Examinations:
- - Schedule for Examinations: Test sites were examined after each patch removal during the induction phase. During the challenge phase, the test site was evaluated immediately after patch removal, then once every 24 hours for 3 days.
EXAMINATIONS
- Grading/Scoring system:
0 = No visible erythema
1 = Erythema
2 = Erythema plus swelling
3 = Erythema, swelling, plus papules
4 = Sever irritation consisting of erythema, swelling papules, and necrosis and extenion beyond the boundries of contact
- Statistical analysis: Statistical consideration were performed using Tables for use with binomial samples (1956) Mainland D et al, Sutcliffe Department of Medical Statistics, New York University of College Medicine.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No visible irritation was observed in any individual after the first application. The test material didn't elicit any visible evidence of irritation in 51 of the individuals under the test. Individual 29 and 37 demonstrated minimal erythema on the 12 and 11th and 12th applications, respectively. This recovered within 24 hours of patch removal.
At challenge, no visible reactions were noted. These were interpreted as skin fatigue and not evidence of irritation. The test material was incapable of acting as a primary irritant.
Any other information on results incl. tables
Table 1: Dermal observations
Subject |
Concentration (%) Skin Titration |
Application (Monday - Thursday) |
Challenge (Day 36) (100 %) |
||||||||||||||
Induction Week 1 (Skin Irritation Titration) |
Induction Week 2 (100 %) |
Induction Week 3 (100%) |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
Immediate Response |
24 Hours |
48 Hours |
72 Hours |
||
1 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
100% |
Dropped out |
|||||||||||||||
6 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
100% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
40% |
Dropped out |
|||||||||||||||
9 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
11 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
13 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
15 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
16 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
17 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
18 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
19 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
40% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
23 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
26 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
27 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
28 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
29 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
31 |
80% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
32 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
33 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
34 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
35 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
36 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
37 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
38 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
39 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
40 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
41 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
42 |
20% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
43 |
20% |
Dropped out |
|||||||||||||||
44 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
45 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
46 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
47 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
49 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
50 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
51 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
52 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
53 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
54 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
55 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
56 |
60% |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, the test material was found to be non-irritating to skin when dosed as the neat material in human volunteers.
- Executive summary:
To determine the irritation and sensitisation potential of the test material, a human repeat insult patch test was performed in 53 human volunteers. The test material was applied via occlusive patch at a dosing rate of 0.1 mL/cm². To determine a suitable dosing regimen, the volunteers were dosed in groups of 10 (minimum) with the following concentrations in petrolatum, 100 %, 80%, 60 %, 40 % and 20 % (titration skin tolerance). The test material was found to be well tolerated, therefore after the first week of induction exposures a single exposure concentration of 100 % was selected for the remained of the study.
Patches were applied Monday through Thursday for 3 weeks, with observations performed after each patch removal. The patch site was rested over the weekend and dosing recommenced the following Monday. A total of 12 inductions applications were administered. On day 36 (just over 2 weeks after the induction exposures), the test material was challenge application was administered as a single exposure at 100 % for 24 hours. The test site was then read at patch removal for immediate response, then again at 24, 48 and 72 hours to determine skin reactions.
No visible irritation was observed in any individual after the first application. The test material didn't elicit any visible evidence of irritation in 51 of the individuals under the test. Individual 29 and 37 demonstrated minimal erythema on the 12 and 11th and 12th applications, respectively. This recovered within 24 hours of patch removal.
At challenge, no visible reactions were noted. These were interpreted as skin fatigue and not evidence of irritation. The test material was incapable of acting as a primary irritant.
Under the conditions of the test, the test material was found to be non-irritating to skin in human volunteers when dosed as the neat material.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.