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EC number: 267-057-3 | CAS number: 67784-87-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GCP-compliant, acceptable and well documented study report which meets basic scientific principles. Lack of details on test material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- Duhring-Kammer-Test (occlusive, epicutaneous patch test) in human volunteers
- GLP compliance:
- no
- Remarks:
- GCP-compliant
Test material
- Reference substance name:
- Glycerides, palm-oil mono- and di-, hydrogenated
- EC Number:
- 267-057-3
- EC Name:
- Glycerides, palm-oil mono- and di-, hydrogenated
- Cas Number:
- 67784-87-6
- Molecular formula:
- C19-39H38-76O4-5
- IUPAC Name:
- 1,3-dihydroxypropan-2-yl hexadecanoate; 1,3-dihydroxypropan-2-yl octadecanoate; 1-hydroxy-3-(octadecanoyloxy)propan-2-yl octadecanoate; 2-(hexadecanoyloxy)-3-hydroxypropyl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Lot/batch No.: MD01785037
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 20
- Sex: male and female
- Age: 21-54 years (mean value: 38.7 years)
- Other: 15 test subjects had normal skin, 5 test subjects had sensitive skin. - Ethical approval:
- not specified
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- TEST SYSTEM
TEST PATCH
- Type of patch: Large-Finn-Chambers (12 mm in diameter) on Scanpor(R)-Patches
- Type of coverage: occlusive
AMOUNT / CONCENTRATION APPLIED
- Amount of test material applied: 70 µL/patch
- Concentration: 20%
- Preparation: The test material was prepared in 60% cosmetic alcohol. The test material was first mixed with the water fraction by stirring and slightly heating. The alcohol fraction was then added to the mixture yielding an emulsion.
VEHICLE
- Vehicle: cosmetic alcohol (98.8%, denaturated) with 0.5% DEP
- Concentration: 60% in demineralized water
CONTROLS
- Reference substances: demineralized water, physiological saline, cosmetic alcohol, 0.5% SDS, 1.0% Texapon N28
DURATION OF TREATMENT / EXPOSURE: 24 h
OBSERVATION PERIOD: 72 h (reading time points: 6, 24, 48 and 72 h)
TEST SITE
- Area of exposure: The occlusive test patches were applied on the back of the test subjects. - Examinations:
- - Skin parameters examined: erythema, edema, scaling and scissures
- Scoring system: The following scoring scale was used to evaluate the degree of effects in the skin parameters examined:
0: no reaction
0.5: very slight reaction
1: slight reaction
2: moderate reaction
3: strong reaction
4: very strong reaction
-1: no response
EVALUATION
- Frequency of skin reactions: The frequency of occurrence of skin reactions and their corresponding degree were determined for all 20 subjects over all 4 reading time points and expressed as the incidence of a skin reaction of a given score out of all 80 individual readings:
Frequency = (incidence n of score m)/80
- Irritation indices
Sum Erythema Index: The sum erythema index was calculated as the overall sum of incidence of erythema multiplied by the assigned score(s) and divided by the number of subjects (20):
Sum Erythema Index = [SUM(erythema incidence n(i) x erythema score m(i))]/20
Sum Irritation Index: The sum irritation index was calculated in analogy to the sum erythema index by additionally taking into account the incidence and corresponding scores of the remaining parameters examined:
Sum Irritation Index = [SUM(skin reaction incidence n(i) x skin reaction score m(i))]/20
- Comparison with reference substances: The results obtained for the test material were compared with those for the (positive) reference substances (0.5% SDS, 1.0% Texapon N28) by calculating the ratio of the sum erythema and irritation indices for the test material and the reference substances, respectively, and expressed as per cent effect of the corresponding reference substance:
[Sum Erythema or Irritation Index (test material) / Sum Erythema or Irritation Index (reference substance)] x 100
STATISTICS
Differences in the frequency and degree of skin reactions between the test material and the (negative) reference substance cosmetic alcohol were determined by means of the two-tailed Wilcoxon rank-sum test. The statistical significance of rank-sum differences was assessed by comparison with tabulated literature values (Wilcoxon-Wilcox: Some rapid approximate statistical procedures, Lederle Laboratories, 1964, Tab. 6, p. 39, 41):
Rank-sum difference (statistical significance): 14.9 (95%*) and 18.5 (99%**)
Results and discussion
- Clinical signs:
- No clinical signs were reported.
- Results of examinations:
- FREQUENCY OF SKIN REACTIONS
Test Material:
- No. of subjects without skin reactions: 14/20
- Erythema: Slight erythema was observed at 1/80 readings.
- Edema: Not observed.
- Scaling: Slight, moderate and strong scaling was observed at 5/80, 3/80 and 1/80 readings, respectively.
- Scissures: Not observed.
Demineralised water (negative reference substance):
- No. of subjects without skin reactions: 19/20
- Erythema: Not observed.
- Edema: Not observed.
- Scaling: Slight scaling was observed at 1/80 readings.
- Scissures: Not observed.
Cosmetic alcohol (negative reference substance):
- No. of subjects without skin reactions: 17/20
- Erythema: Slight erythema was observed at 1/80 readings.
- Edema: Not observed.
- Scaling: Slight and moderate scaling was observed at 3/80 and 1/80 readings, respectively.
- Scissures: Not observed.
Physiological saline (negative reference substance):
- No. of subjects without skin reactions: 19/20
- Erythema: Not observed.
- Edema: Not observed.
- Scaling: Slight scaling was observed at 1/80 readings.
- Scissures: Not observed.
0.5% SDS (positive reference substance):
- No. of subjects without skin reactions: 2/20
- Erythema: Slight, moderate and strong erythema was observed at 24/80, 14/80 and 2/80 readings, respectively.
- Edema: Slight and moderate edema was observed at 5/80 and 1/80 readings, respectively.
- Scaling: Slight, moderate, strong and very strong scaling was observed at 13/80, 20/80, 10/80 and 2/80 readings, respectively.
- Scissures: Slight, moderate and strong scissures were observed at 4/80, 4/80 and 1/80 readings, respectively.
1.0% Texapon N28 (positive reference substance):
- No. of subjects without skin reactions: 5/20
- Erythema: Slight erythema was observed at 16/80 readings.
- Edema: Not observed.
- Scaling: Slight, moderate and strong scaling was observed at 17/80, 4/80 and 1/80 readings, respectively.
- Scissures: Not observed.
IRRITATION INDICES
The Sum Erythema and Irritation Indices for the test material were 0.05 and 0.75, and comparable to those obtained for the negative reference substance cosmetic alcohol (0.05, 0.30). Corresponding values for the negative reference substances demineralised water (0.00, 0.05) and physiological saline (0.00, 0.05) were lower.
The Sum Erythema and Irritation Indices for the positive references substances 0.5% SDS (2.90, 8.10) and 1.0% Texapon N28 (0.80, 2.20) were higher as expected.
COMPARISON OF RESULTS BETWEEN TEST MATERIAL AND (POSITIVE) REFERENCE SUBSTANCES (Table 3)
The per cent erythema effect for the test material compared with the positive reference substances 0.5% SDS and 1.0% Texapon N28 was 1.7 and 6.2%, respectively.
The overall per cent skin reaction for the test material compared with the positive reference substances 0.5% SDS and 1.0% Texapon N28 was 9.3 and 34.1%, respectively.
RANK-SUM DIFFERENCES AND STATISTICAL SIGNIFICANCE (Table 4)
No statistically significant rank-sum differences were observed between the test material and the reference substance cosmetic alcohol for any of the skin parameters examined.
OVERALL EVALUATION
Under the test conditions of the study, the skin compatibility of the test material (20% AS in 60% cosmetic alcohol) was not significantly different in comparison with pure cosmetic alcohol. Thus, the test material shows a good skin compatibility.
Any other information on results incl. tables
Table 1. Frequency of skin reactions and degree (scores).
Substance |
Subjects without reactions |
Erythema |
Edema |
Scaling |
Scissures |
|||||||||||||||||||
0.5 |
1 |
2 |
3 |
4 |
0 |
0.5 |
1 |
2 |
3 |
4 |
0 |
0.5 |
1 |
2 |
3 |
4 |
0 |
0.5 |
1 |
2 |
3 |
0 |
||
Test material |
14/20 |
0 |
1 |
0 |
0 |
0 |
79 |
0 |
0 |
0 |
0 |
0 |
80 |
0 |
5 |
3 |
1 |
0 |
71 |
0 |
0 |
0 |
0 |
80 |
Demineralised water |
19/20 |
0 |
0 |
0 |
0 |
0 |
80 |
0 |
0 |
0 |
0 |
0 |
80 |
0 |
1 |
0 |
0 |
0 |
79 |
0 |
0 |
0 |
0 |
80 |
Cosmetic alcohol |
17/20 |
0 |
1 |
0 |
0 |
0 |
79 |
0 |
0 |
0 |
0 |
0 |
80 |
0 |
3 |
1 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
80 |
Physiological saline |
19/20 |
0 |
0 |
0 |
0 |
0 |
80 |
0 |
0 |
0 |
0 |
0 |
80 |
0 |
1 |
0 |
0 |
0 |
79 |
0 |
0 |
0 |
0 |
80 |
0.5% SDS |
2/20 |
0 |
24 |
14 |
2 |
0 |
40 |
0 |
5 |
1 |
0 |
0 |
74 |
0 |
13 |
20 |
10 |
2 |
35 |
0 |
4 |
4 |
1 |
75 |
1.0% Texapon N28 |
5/20 |
0 |
16 |
0 |
0 |
0 |
64 |
0 |
0 |
0 |
0 |
0 |
80 |
0 |
17 |
4 |
1 |
0 |
58 |
0 |
0 |
0 |
0 |
80 |
Table 2. Irritation indices.
Substance |
Sum Erythema Index |
Sum Irritation Index (erythema + edema + scaling + scissures) |
Test material |
0.05 |
0.75 |
Demineralised water |
0.00 |
0.05 |
Cosmetic alcohol |
0.05 |
0.30 |
Physiological saline |
0.00 |
0.05 |
0.5% SDS |
1.90 |
8.10 |
1.0% Texapon N28 |
0.80 |
2.20 |
Table 3. Comparison with (positive) reference substances.
Substance |
Per cent effect compared with reference substance |
|||
Erythema |
Erythema + Edema + Scaling + Scissures |
|||
0.5% SDS |
1.0% Texapon N28 |
0.5% SDS |
1.0% Texapon N28 |
|
Test material |
1.7% |
6.2% |
9.3% |
34.1% |
Table 4. Rank-sum differences between test material and (negative) reference substance cosmetic alcohol and statistical significance (Wilcoxon rank-sum test).
Skin reaction |
Rank-sum difference |
Statistical significance (two-tailed) |
Erythema |
0.0 |
no |
Edema |
identical |
- |
Scaling |
6.5 |
no |
Scissures |
identical |
- |
Applicant's summary and conclusion
- Conclusions:
- Not skin irritating (at 20% AS in 60% cosmetic alcohol)
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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