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EC number: 696-616-8 | CAS number: 1268344-02-0
- 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
Endpoint summary
Administrative data
Description of key information
A recent GLP Maximisation has shown Oleyl-diamine3EO not to be sensitising to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 April 2001 - 19 May 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent guideline study under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vivo GPMT study was available pre-REACh.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 300 - 45Og
- Housing: n pairs in solid-floor polypropylene cages furnished with woodflake
- Diet: ad libitum (Guinea pig FDl Diet, Special Diets Services Limited, Witham, Essex, UK)
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction intra dermal: 0.1%; epicutaneous: 5%
challenge: 1% & 2% - Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction intra dermal: 0.1%; epicutaneous: 5%
challenge: 1% & 2% - No. of animals per dose:
- 10 test, 5 control
- Details on study design:
- RANGE FINDING TESTS:
intra dermal: 4 animals: 5%, 1%, 0.5%, 0.1% (1 animal per dose)
epicutaneous dose (48hr):
2 animals: 100%, 75%, 50%, 25% (all levels in each animal)
2 animals: 10%, 5%, 2%, 1% (all levels in each animal)
Challenge (24 hr): 2 animals: 10%, 5%, 2%, 1% (all levels in each animal)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 i.d., 1 epicutaneous
- Exposure period: 48 hr
- Test groups: 10 animals: 0.1 ml of: A: FCA/water 1:1; B: 0.1% test metarial in arachis oil; C: 0.1% test in a 1:1 preparation FCA/water;
saturated with 5% test susbatnce filter paper 40x20 mm for 48 hrs under occlusion
- Control group: 5 animals similar, except only vehicle instead of test substance.
- Site: A row of three injections (0.1 ml each) was made on each side of the mid-line into a 20 mm x 40 mm area on the shoulder region
- Frequency of applications: day 0: i.d., day 7 epicutaneous
- Concentrations: Induction intra dermal: 0.1%; epicutaneous: 5%; challenge: 1% & 2%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 hrs exposure
- Test groups & Control group: saturated filter paper 20x20 mm with 1% & 2% test substance in arachis oil, for 24 hrs under occlusion. After 24 hr removal patches, and sites were wabbed with cotton wool soaked in diethyl ether
- Site: 2% on shorn right flank; 1% on left flank
- Evaluation (hr after challenge): 24 and 48 hr after removal - Positive control substance(s):
- yes
- Remarks:
- historic list with 2-Mercaptobenzothiazole and alpha-Hexylcinnamaldehyde
- Positive control results:
- Positive control performed run 3 month earlier showed adequate reactions: alpha-Hexylcinnamaldehyde: Induction intradermal: 5% in arachis oil, topical 100%; challenge 100% and 75% in arachis oil: results 40% (4/10) sensistisation.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% and 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% and 2%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% and 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% and 2%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% and 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% and 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other:
- Group:
- positive control
- Dose level:
- 100% & 75%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- a-Hexylcmnamaldehyde: Induction: intradermal 5% in arachis oil BP; topical: 100%. Challenge: 100% and 75% in arachis oil BP
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- 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.
- Executive summary:
Introduction.
The study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The method was designed to meet the requirements of the following:
• GECD Guidelines for the Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992)
• Commission Directive96/54/ECMethod B6 Acute Toxicity (Skin Sensitisation)
Method.
Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response.
Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as:
Intradermal Induction 0.1% v/v in arachis oil BP
Topical Induction 5% v/v in arachis oil BP
Topical Challenge 2% and 1% v/v in arachis oil BP
Conclusion.
Under the conditions of the test, the test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 93/211EEC. No symbol and risk phrase are required.
Reference
Individual Skin Reactions at Challenge
|
|
24 Hours |
48 Hours |
||||||||||
|
|
1% |
2% |
1% |
2% |
||||||||
Group |
Animal |
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 |
- |
Intradermal Induction - Individual Skin Reactions
Grade of Erythema at Observation Site
|
|
24 Hours |
48 Hours |
||
Group |
Animal |
Left Side |
Right Side |
Left Side |
Right Side |
TEST |
1 |
2 |
2 |
2 |
2 |
|
2 |
2 |
2 |
2 |
2 |
|
3 |
2 |
2 |
2 |
2 |
|
4 |
2 |
2 |
2 |
2 |
|
5 |
2 |
2 |
2 |
2 |
|
6 |
2 |
2 |
2 |
2 |
|
7 |
2 |
2 |
2 |
2 |
|
8 |
2 |
2 |
2 |
2 |
|
9 |
2 |
2 |
2 |
2 |
|
10 |
2 |
2 |
2 |
2 |
|
11 |
2 |
1 |
1 |
0 |
|
12 |
1 |
2 |
0 |
0 |
CONTROL |
13 |
1 |
1 |
0 |
0 |
|
14 |
1 |
1 |
0 |
0 |
|
15 |
1 |
2 |
0 |
0 |
Topical Induction - Individual Skin Reactions
Skin Reactions (Hours After Removal of Dressing)
|
|
1 Hour |
24 Hours |
||||
Group |
Animal |
Er |
Oe |
Other |
Er |
Oe |
Other |
TEST |
1 |
2 |
0 |
- |
2 |
0 |
- |
|
2 |
1 |
0 |
- |
1 |
0 |
- |
|
3 |
2 |
0 |
Bs |
?e |
?od |
St |
|
4 |
2 |
0 |
Bs |
?e |
?od |
St |
|
5 |
2 |
0 |
Bs |
?e |
?od |
St |
|
6 |
1 |
0 |
- |
1 |
0 |
- |
|
7 |
2 |
0 |
Bs |
2 |
0 |
Bs |
|
8 |
2 |
0 |
Bs |
?e |
?od |
St |
|
9 |
2 |
0 |
Bs |
?e |
?od |
St |
|
10 |
2 |
0 |
Bs |
?e |
?od |
St |
CONTROL |
11 |
1 |
0 |
- |
0 |
0 |
- |
|
12 |
1 |
0 |
Bs |
0 |
0 |
- |
|
13 |
1 |
0 |
- |
0 |
0 |
- |
|
14 |
1 |
0 |
- |
0 |
0 |
- |
|
15 |
2 |
0 |
Bs |
0 |
0 |
- |
Er = Erythema Oe = Oedema
Bs = Bleeding from intradermal injection sites
?e = Adverse reactions prevent evaluation of erythema
- = No other reactions noted
St = Hardened dark brown/black-coloured scabs
?od = adverse reactions prevent evaluation of oedema
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is one study available in which Oleyl-diamine3EO has been evaluated for skin sensitising properties. The study was performed in Guinea pigs according to OECD 406 Maximisation test method, and in compliance to GLP, using ten test and five control animals. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as:
Intradermal Induction 0.1% v/v in arachis oil
Topical Induction 5% v/v in arachis oil
Topical Challenge 2% and 1% v/v in arachis oil
Under the conditions of the test, the test material produced a 0% (0/10) sensitisation rate.
Consequently, Oleyl-diamine3EO is considered not to possess sensitising properties.
Further information that should be considered:
- These substances are corrosive to skin.
- The profiling of these substances do not indicate reactivity to protein; No alerts for sensitisation are given by QSARs on these structures (Derek Nexus: 6.0.1: non-sensitiser; No misclassified or unclassified features)
- No concerns from structural analogues
- No concerns have been raised from the use/application of these products with respect to the occurrence of sensitisation (or contact dermatitis).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no information on respiratory sensitisation. However, no concerns are expected.
As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non respiratory sensitisation of the substance.
Additionally, the likelihood for exposure via inhalation and thus becoming sensitised to Oleyl-diamine3EO, is very low, based on the high boiling point (> 300 °C) and very low vapour pressure (< 0.0015 Pa at 20°C) and use that is limited to industrial and professional users and which does not involve the forming of aerosols, particles or droplets of an inhalable size.
Justification for classification or non-classification
Oleyl-diamine3EO has shown to be non-sensitising in a adequately performed Guinea pig study following the Magnusson and Kligman Maximisation Method. Consequently, the substance does not need to be classified for sensitisation.
These negative results for skin sensitisation can also be regarded as indicating the lack of the potential to cause allergic sensitisation of the respiratory tract.
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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