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EC number: 270-418-8 | CAS number: 68439-75-8 This substance is identified by SDA Substance Name: C12-C18 dialkyl methyl amine and SDA Reporting Number: 16-043-00.
- 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:
- From 10-03-1990 to 11-23-1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- There is no information of Amines, di-C12-18-alkylmethyl (CAS No.: 68439-75-8; EC No.: 270-418-8) itself but there is information available for Amines, di-C16-18-alkylmethyl (CAS No.: 1227096-04-9; EC No.: 627-132-7) which is structurally similar to Amines, di-C12-18-alkylmethyl.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Reliability scoring based on 1981 guideline for test n°406
- Deviations:
- yes
- Remarks:
- : no data reported on the positive control in the report
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method has been proven to give false positives for this type of substances. This test was conducted pre-LLNA. There is a viable GPMT conducted according to GLP and OECD guidelines available.
Test material
- Reference substance name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC Number:
- 627-132-7
- Cas Number:
- 1227096-04-9
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- Test material form:
- solid
- Remarks:
- waxy
- Details on test material:
- - Chemical name: N-decyl-N-methyldecan-1-amine
- EC number: 627-132-7
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”
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: Olac Limited, Bicester, Oxfordshire, England
- Age before acclimatation period: 4-6 weeks old
- Weight at study initiation: 330-451 g
- Housing: in stainless steel cages with grid floors, 5 animals of the same sexe in each cage
- Diet : ad libitum (samples of diet were analysed to detect contamination by PCB and chlorinated hydrocarbons)
- Water: ad libitum
- Acclimation period: yes but no more precision
ENVIRONMENTAL CONDITIONS
- Temperature : 18-20 °C
- Humidity: below 40 %
- Air changes : 15 per hour
- Photoperiod (hrs dark / hrs light):12/12 (no source of natural light)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- - Induction exposure:
intrademal: 10% w/v Test Substance (TS) in vehicle
occlusive epicutaneous: 10% w/v
- Challenge exposure:
occlusive epicutaneous: 3 % w/v and 0.5 % w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- - Induction exposure:
intrademal: 10% w/v Test Substance (TS) in vehicle
occlusive epicutaneous: 10% w/v
- Challenge exposure:
occlusive epicutaneous: 3 % w/v and 0.5 % w/v
- No. of animals per dose:
- Control group: 10 animals (5 males and 5 females)
Treated group: 20 animals (10 males and 10 females) - Details on study design:
- RANGE FINDING TESTS: conducted to define the concentrations to be tested in the main study.
Intradermal exposure:
24 hours before treatment: dorsal region clipped.
Intradermal administration of 0.1 mL of the test substance (TS) at increasing concentrations.
Evaluation of the potential cutaneous reactions 24 and 48 hours and approximately 168 hours after injection.
Epicutaneous exposure:
24 hours before treatment: dorsal region clipped.
0.4 mL of each concentration applied to a gauze patch of approximately 4 cm2 for 48 hours by occlusive dressing (4 concentrations per animal).
Evaluation of the potential cutaneous reactions 24 and 48 hours after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epicutaneous
- Exposure period: epicutaneous: 48 hours
-> TEST GROUPS:
Intradermal exposure
Three injections of 0.1 mL were injected into each side of the animal as follows:
. Freund's complete adjuvant (FCA) diluted to 50% with distilled water
. TS at 10% w/v in vehicle
. TS at 5% w/v in a 50/50 (v/v) mixture of FCA and distilled water
Epicutaneous exposure
Application of 0.6 mL of TSat 10% w/v in paraffin oil applied to the scapular region and held in place for 48 hours using an occlusive dressing.
-> CONTROL GROUP:
Intradermal exposure
Three injections of 0.1 mL were injected into each side of the animal as follows:
. Freund's complete adjuvant (FCA) diluted to 50% with distilled water
. vehicle
. A mixture 50/50 (v/v) FCA diluted to 50% with distilled water, and vehicle
Epicutaneous exposure
Application of 0.6 mL of vehicle applied to the scapular region and held in place for 48 hours using an ocular dressing.
- Site:
Intradermal exposure
6 injections in the clipped area (4 x 2 cm) in the scapular region
Epicutaneous exposure
4 x 2 cmarea over the scapulae
- Frequency of applications:
One intradermal injection and one epicutaneous application 8 days after on the same site.
- Duration:
Epicutaneous exposure: 48 hours
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
-> TEST GROUPS:
0.03 mL of the TS at 3% w/v in vehicule to one site and 0.03 mL of the TS at 0.5% w/v in vehicule to a second site on the posterior right flank (occlusiv e epicutaneous application)
0.03 mL of the vehicle on the posterior left flank (occlusive epicutaneous application)
-> CONTROL GROUPS:
Same treatment as test group
- Site: posterior right and left flanks
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressing
- Challenge controls:
- Vehicle was applied at the challenge application on the posterior left flank of both test and control groups of animals.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data. Data available in two other studies from the same laboratory witin the vaidation winow of 6 months - Valid
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenged with Armeen M2HT 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenged with Armeen M2HT 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenged with Armeen M2HT 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Challenged with Armeen M2HT 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induced with Armeen M2HT and challenged with Armeen M2HT 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induced with Armeen M2HT and challenged with Armeen M2HT 3%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induced with Armeen M2HT and challenged with Armeen M2HT 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induced with Armeen M2HT and challenged with Armeen M2HT 3%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenged with Armeen M2HT 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenged with Armeen M2HT 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenged with Armeen M2HT 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: challenged with Armeen M2HT 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induced with Armeen M2HT and challenged with Armeen M2HT 0.5 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induced with Armeen M2HT and challenged with Armeen M2HT 0.5 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induced with Armeen M2HT and challenged with Armeen M2HT 0.5 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induced with Armeen M2HT and challenged with Armeen M2HT 0.5 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenged with paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenged with paraffin oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenged with paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: challenged with paraffin oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induced with Armeen M2HT and challenged with paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induced with Armeen M2HT and challenged with paraffin oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induced with Armeen M2HT and challenged with paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induced with Armeen M2HT and challenged with paraffin oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
CHALLENGE PHASE: individual dermal responses after removal of occlusive dressings
Group |
Sexe |
Animal |
Topical application of 0.03 ml 3 %w/v Armeen in paraffin oil |
Topical application of 0.03 ml 0.5 %w/v Armeen in paraffin oil |
Topical application of 0.03 ml paraffin oil |
|||
24 hours after removal of dressing |
48 hours after removal of dressing |
24 hours after removal of dressing |
48 hours after removal of dressing |
24 hours after removal of dressing |
48 hours after removal of dressing |
|||
Control |
M |
601 |
0 |
0 |
0 |
0 |
0 |
0 |
602 |
0 |
0 |
+- |
+- |
0 |
0 |
||
603 |
0 |
0 |
0 |
0 |
0 |
0 |
||
604 |
0 |
0 |
0 |
0 |
+- |
+- |
||
605 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Control |
F |
606 |
0 |
0 |
0 |
0 |
0 |
0 |
607 |
0 |
0 |
0 |
0 |
0 |
0 |
||
608 |
0 |
0 |
0 |
0 |
+- |
+- |
||
609 |
0 |
0 |
0 |
0 |
0 |
0 |
||
610 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Treated |
M |
611 |
+- |
0 |
0 |
0 |
0 |
0 |
612 |
+- |
0 |
0 |
0 |
0 |
0 |
||
613 |
0 |
0 |
0 |
+- |
0 |
0 |
||
614 |
+- |
+- |
+- |
+- |
+- |
+- |
||
615 |
+- |
+- |
+- |
0 |
+- |
0 |
||
616 |
0 |
0 |
0 |
+- |
0 |
0 |
||
617 |
+- |
0 |
0 |
0 |
+- |
0 |
||
618 |
0 |
0 |
0 |
0 |
+- |
+- |
||
619 |
+- |
0 |
+- |
0 |
0 |
0 |
||
620 |
0 |
+- |
0 |
+- |
+- |
0 |
||
Treated |
F |
621 |
0 |
0 |
0 |
0 |
0 |
0 |
622 |
0 |
0 |
0 |
0 |
0 |
0 |
||
623 |
0 |
0 |
0 |
0 |
+- |
+- |
||
624 |
+- |
0 |
0 |
0 |
0 |
0 |
||
625 |
+- |
1 |
0 |
1 |
+- |
+- |
||
626 |
+- |
+- |
+- |
1 |
0 |
0 |
||
627 |
+- |
0 |
+- |
0 |
+- |
+- |
||
628 |
1 |
0 |
0 |
+- |
0 |
0 |
||
629 |
+- |
0 |
0 |
0 |
+- |
0 |
||
630 |
0 |
0 |
0 |
1 |
0 |
0 |
0: No response
+-: Barely perceptible erythema
1: Slight erythema
2: Moderate erythema
3: Severe erythemaApplicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In the treated group, following cutaneous reactions were noted:
-Challenge application of 3 % w/v Armeen M2HT in paraffin oil caused slight erythema in 1 out of 20 animals in the treated group after the 24 and the 48-hour readings and no cutaneous reactions in the control group.
-Challenge application of 0.5 % w/v Armeen M2HT in paraffin oil caused slight erythema in 3 and 1 out of 20 treated animals after the 24 and 48-hour readings respectively. No cutaneous reactions were observed in the control group.
-Challenge application of paraffin oil alone caused caused no significant cutaneous reaction. - Executive summary:
The potential of Armeen M2HT to induce delayed contact hypersensitivity was assessed in guinea pigs according to the OECD guideline 406 and conducted in compliance with the principles of Good Laboratory Practice regulations.
Positive controls were not included in the study though guideline equivalent GPMT studies on Armoblen 600 & NAPAA were conducted with positive controls that were successful 6 months prior to and 3 months after respectively of this test in the same contract laboratory. This is consistent with the OECD guideline need for reliability checks in the place of positive controls. Further information on these studies can be found in section 7.12 "Additional toxicological information".
The induction phase has been realized both by intradermal route on day 1 (Armeen M2HT 10 % w/v in paraffin oil) and by cutaneous route on day 8 (Armeen M2HT 10% w/v in paraffin oil ) in 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 22 by cutaneous application of Armeen M2HT 3% and Armeen M2HT 0.5% w/v in paraffin oil on two sites on the right flank (vehicle on the left flank). the cutaneous reactions were scored 24 and 48 hours after the challenge phase.
After the challenge application with 3 % w/v Armeen 2HT in paraffin oil, a slight erythema was observed in 1/ 20 animals of the treated group at the 24 and 48-hour readings. No cutaneous reactions were recorded in the control group.
After the challenge application with 0.5 % w/v Armeen 2HT in paraffin oil, a slight erythema was observed in 3 and 1 out the 20 animals of the treated group at the 24 and 48-hour readings respectively.
The persistent cutaneous reactions observed in 4/20 animals of the treated group after the challenge application may be attributable to delayed contact hypersensitivity but as the cutaneous reactions were more confined to the 24 hour examination, they were more consistent with irritation than delayed contact hypersensitivity.
Therefore, the cutaneous reactions observed in 4/20 animals (20%) of the treated groups were considered as irritative response and the substance was not considered as a skin sensitiser.
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