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EC number: 817-761-7 | 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Jun - 26 Jul 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 92/96 EEC
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was started before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- EC Number:
- 817-761-7
- Cas Number:
- 765293-81-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- Test material form:
- other: paste
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, UK (sighting tests) and Harlan UK Limited, Bicester, UK (main study).
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 326 – 548 g
- Housing: Animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Certified guinea pig Diet (Code 5026) supplied by PMI Nutrition International (Nottingham, UK) and IPS Product Supplies Limited, Wellingborough, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 -70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.1 mL 5% (v/v)
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- other: 5% (v/v) of the test material caused mild to moderate skin irritation and was well tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted test material
- Day(s)/duration:
- Day 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- undiluted test substance and 75% (v/v) test substance in arachis oil treated in two sites
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- other: highest non-irritant concentration and one lower concentration
- No. of animals per dose:
- 10 (test group), 5 (controls)
- Details on study design:
- Selection of concentration for intradermal induction:
Intradermal injections (0.1 mL/injection site) were made on the clipped shoulder of one guinea pig using a concentration of 5% (v/v) in arachis oil. The degree of erythema at the injection sites was assessed approximately 24, 48, 72 h and 7 days after injection. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of the main study.
Selection of concentration for topical induction:
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant eight days earlier) were treated with the undiluted test substance and with test material concentrations of 75, 50 and 25% (v/v) in arachis oil. Applications were made under occlusive dressings for 48 h. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 h after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
Selection of concentration for topical challenge:
The undiluted test material and test material concentrations of 75, 50 and 25% (v/v) in arachis oil were applied to two guinea pigs under occlusive dressings for 24 h. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 h after dressing removal. The highest non-irritant concentration of the test substance and one lower concentration were selected for the topical challenge stage of the main study.
Based on the results of the sighting tests, 5% (v/v) concentration of the test material was determinded for intradermal injection, the undiluted test substance (100%) was selected for topical induction, the undiluted test substance and 75% (v/v) of the test material (two sites) was used for topical challenge in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections; 0.1 mL each):
Injection 1: Freund’s Complete Adjuvant (FCA) plus distilled water in the ratio 1:1
Injection 2: 5% (v/v) test material in arachis oil
Injection 3: 5% (v/v) test material in a 1:1 preparation of FCA plus distilled water
Epicutaneous: undiluted test substance
- Control group:
Intradermal (3 pairs of injections; 0.1 mL):
Injection 1: FCA plus distilled water in the ratio 1:1
Injection 2: arachis oil
Injection 3: arachis oil at 50% in 1:1 preparation of FCA plus distilled water
Epicutaneous: arachis oil
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal: 5% (v/v), epicutaneous: undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: undiluted test substance and 75% (v/v) test substance in arachis oil
- Control group: undiluted test substance and 75% (v/v) test substance in arachis oil
- Site: right flank (undiluted test substance) and left flank (75% (v/v) test substance in arachis oil)
- Concentrations: undiluted test substance and 75% (v/v) test substance in arachis oil
- Evaluation (hr after challenge): 24 and 48 hours after challenge dressing removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- In the last reliability check (22 May - 15 Jun 2002) 2-mercaptobenzothiazole was used as positive control substance (intradermal: 5% in arachis oil, topical: 50% in acetone:PEG 400 (70:30); challenge: 25 and 50% in acetone:PEG 400 (70:30)).
Results and discussion
- Positive control results:
- The positive control 2-mercaptobenzothiazole (reliability check of May/June 2002) induced positive reactions ins 8/10 guinea pigs (80%) thus meeting the reliability criteria for the guinea pig maximisation test (≥ 30% positive response).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 5% (v/v); challenge: 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 5% (v/v); challenge: undiluted test substance (100%)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 5% (v/v); challenge: 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 5% (v/v); challenge: undiluted test substance (100%)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: undiluted test substance (100%)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: undiluted test substance (100%)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- intradermal induction: 5% in arachis oil, topical induction: 50% in acetone:PEG 400 (70:30); challenge: 25 and 50% in acetone:PEG 400 (70:30)
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1 Individual skin reactions at challenge
Group |
Animal Number |
Skin reactions (Hours after removal of dressings) |
|||||||||||
75% |
100% |
||||||||||||
24 hours |
48 hours |
24 hours |
48 hours |
||||||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
||
Test |
1 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
2 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
3 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
4 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
5 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
6 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
7 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
8 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
9 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
10 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
Control |
11 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
12 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
13 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
14 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
|
15 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
* Er = Erythema, Oe = Oedema, - = No other reactions noted
Table 2 Scales for evaluation of skin reactions – Magnusson and Kligman maximization method
EVALUATION OF ERYTHEMA# |
VALUE |
No erythema |
0 |
Barely perceptible erythema |
± |
Discrete or patchy erythema |
1 |
Moderate and confluent erythema |
2 |
Intense erythema and swelling |
3 |
|
|
EVALUATION OF OEDEMA# |
VALUE |
No oedema |
0 |
Very slight oedema (barely perceptible) |
1 |
Slight oedema (edges of area well – defined by definite raising) |
2 |
Moderate oedema (raised approximately 1 millimetre) |
3 |
Severe oedema (raised more than 1 millimetre extending beyond the area of exposure) |
4 |
Moderate and confluent erythema was noted at the intradermal induction sites of test group animals, discrete or patchy to moderate and confluent erythema was noted at the intradermal induction sites of control group animals.
Discrete or patchy to moderate and confluent erythema was noted at the topical induction sites of test group animals, and bleeding from the intradermal injection sites was noted in one test group animals. Discrete or patchy erythema and very slight oedema was noted at the topical induction sites of control group animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin under the conditions of the test.
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