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EC number: 800-362-7 | CAS number: 1307863-78-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 9 Oct 2003 - 7 Dec 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Oleyl diamine, dioleate
- IUPAC Name:
- Oleyl diamine, dioleate
- Test material form:
- other: fluid
- Details on test material:
- name: INIPOL 002
batch number: 11638106
CAS No: 40027-38-1
Chemical name: N-alkyl "oleyl" propylene diamine dioleate
Sponsor's filing number: GRL 0023/03
description: orange-colored viscous liquid
container: one glass flask
date of receipt: 22 September 2003
storage conditions: at room temperature and protected from light
purity: 97.4%
composition: see analytical certificate
expiry date: September 2004.
spec. gravity: 870 kg/m3 at 50°C
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Hartley Crl: (HA) BR, Caesarian obtained, Barrier sustained - Virus Antibody Free (COBS - VAF).
- Source: Charles River Laboratories France, L’Arbresle, France.
- Age at study initiation: 1-2 months old
- Weight at study initiation: mean body weight ± standard deviation of 373 ± 21 g for the males and 378 ± 11 g for the females.
- Housing: individually in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm) equipped with a polypropylene bottle. Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 9 October 2003 (start preliminary test) To: 7 Dec 2003 (sacrifice animals upon completion)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal: corn oil,; topical (induction and challenge) Acetone
- Concentration / amount:
- Intradermal: 0.1% (w/w)
topical induction: 25% (w/w)
challenge: first challenge 10 (w/w), second challenge 5% and 1%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal: corn oil,; topical (induction and challenge) Acetone
- Concentration / amount:
- Intradermal: 0.1% (w/w)
topical induction: 25% (w/w)
challenge: first challenge 10 (w/w), second challenge 5% and 1%
- No. of animals per dose:
- Positive control group: five control and ten treated females
preliminary test: 4 males and 4 females
Control group: 5 males and 5 females and again 5 males and 5 females for second challenge treatment group
Treated group: 10 males and 10 females - Details on study design:
- RANGE FINDING TESTS:
By intradermal route (tested concentrations: 25%, 10%, 5%, 1% and 0.1% (w/w)):
- intradermal injections of the dosage form preparations (0.1 mL) were performed in the interscapular region,
- local reactions were evaluated approximately 24, 48 hours and 6 days after the injections.
By cutaneous route: Under the conditions of the induction phase (tested concentrations: 100%, 25%, 10% and 5% (w/w)):
- a filter paper (approximately 8 cm2) was fully-loaded with a dosage form preparation and was then applied to the clipped area of the skin. The filter paper was held in place by means of an occlusive dressing for 48 hours,
- cutaneous reactions were evaluated 24 and 48 hours after removal of the dressing.
Under the conditions of the challenge phase (tested concentrations: 100%, 25%, 10% and 5% (w/w)):
- the filter paper of a chamber (Finn Chamber) was fully-loaded with a dosage form preparation. The chamber was then applied to the clipped area of the skin (one concentration per flank). The chamber was held in place by means of an occlusive dressing for 24 hours,
- cutaneous reactions were evaluated 24 and 48 hours after removal of the dressings.
MAIN STUDY
A. INDUCTION EXPOSURE
Three injections of 0.1 mL were made into each side of this interscapular region (i.e. three pairs of sites), as follows:
1 Anterior site: FCA at 50% (v/v) in 0.9% NaCl
2 Middle location: test item at 0.1% (w/w) in 0.9% NaCl /corn oil
3 Posterior site: test item at 0.1% (w/w) in the mixture FCA/0.9% NaCl (50/50)
Cuteneous route:
(No SLS needed as substance was irritating)
On day 8, fully loaded filter paper (approximately 8 cm2) with 25% (w/w), applied on interscapular region for 48 hours. On removal of the dressing (day 10), no residual test item was observed.
A local irritation was recorded in all the animals of both groups.
B. CHALLENGE EXPOSURE
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- all animals:
- Posterior right flank: filter paper of a chamber (Finn Chamber) was fully-loaded with the test item
- Posterior left flank: vehicle
- Concentrations: 10% (w/w)
- Evaluation (hr after challenge): 24 and 48 after removal of the dressing
Following equivocal cutaneous reactions, a second challenge was performed after a rest period of 17 days.
- Day(s) of challenge: day 22
- Concentrations: 5% (w/w) to median left flank and 1% (w/w) to median right flank
(otherwise as above) - Challenge controls:
- Yes, similar as treated group
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
- Positive control results:
- Concentration :
induction phase: 1% (w/w) on day 1 (intradermal route); 20% (w/w) on day 8 (cutaneous route)
challenge phase: 20% (w/w) on day 22 (cutaneous route)
Vehicle : corn oil
Mercaptobenzothiazole at the concentration of 20% (w/w) induced positive skin sensitization reactions in 100% (10/10) guinea pigs.
In vivo (non-LLNA)
Results
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 18
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 18.0.
Any other information on results incl. tables
CHOICE OF THE VEHICLE
The test item was not soluble in 0.9% NaCl: two phases were observed.
The vehicle chosen for intradermal injections was corn oil: a homogeneous dosage form preparation was obtained at the maximum concentration of 25%(w/w); the dosage form preparation at the concentration of 25% (w/w) passed freely through a needle and into the dermis.
For topical applications (induction phase and challenge application), the vehicle used was acetone: a homogeneous dosage form preparation was obtained at the maximum concentration of 25% (w/w).
PRELIMINARY STUDY
Administration by intradermal route: 25, 10 and 5% resulted to necrosis within 24 hours. At 1% necrosis became evident after 48 hours.
At 0.1% irritation was observed.
Application by cutaneous route for induction: 100% resulted to necrosis. At 25% irritation (discrete or patchy erythema) was observed, with crusts at 48 hours. At 10% and 5% no irritation was observed.
Application by cutaneous route under conditions of challenge phase (2 animals / concentration):
100% resulted to necrosis. 25% resulted to irritation in one of the two animals.
10% and 5% did not result to irritation in either animal.
MAIN STUDY:
Clinical examinations
Marked local reactions at the intradermal injection sites were noted in a few animals of the treated group between days 7 and 36. Therefore, two animals (female Nos. 83 and 90) were sacrificed on day 22 for ethical reasons.
No systemic clinical signs and no deaths related to treatment were observed during the study.
Body weight
The body weight gain of the treated animals was similar to that of controls (appendix 3).
Challenge phase- Scoring of cutaneous reactions
On removal of the dressing, no residual test item was observed.
First challenge application:
Control group 1 |
|||||
Sex |
Animal |
24 hours |
48 hours |
||
|
number |
LF |
RF |
LF |
RF |
Male |
61 |
0 |
2 |
0 |
2/S |
|
62 |
0 |
1 |
0 |
1/S |
|
63 |
0 |
0 |
0 |
0 |
|
64 |
0 |
2 |
0 |
2 |
|
65 |
0 |
0 |
0 |
0 |
Female |
76 |
0 |
0 |
0 |
0 |
|
77 |
0 |
0 |
0 |
0 |
|
78 |
0 |
0 |
0 |
1 |
|
79 |
0 |
0 |
0 |
1 |
|
80 |
0 |
0 |
0 |
0 |
Treated group 2 |
|||||
Sex |
Animal |
24 hours |
48 hours |
||
|
number |
LF |
RF |
LF |
RF |
Male |
66 |
0 |
1 |
0 |
2 |
|
67 |
0 |
0 |
0 |
1 |
|
68 |
0 |
1 |
0 |
2 |
|
69 |
0 |
1 |
0 |
2/S |
|
70 |
0 |
1 |
0 |
1/S |
|
71 |
0 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
1 |
|
73 |
0 |
1 |
0 |
2/S |
|
74 |
0 |
0 |
0 |
0 |
|
75 |
0 |
0 |
0 |
0 |
Female |
81 |
0 |
0 |
0 |
0 |
|
82 |
0 |
0 |
0 |
1 |
|
83 |
- |
- |
- |
- |
|
84 |
0 |
0 |
0 |
0 |
|
85 |
0 |
0 |
0 |
0 |
|
86 |
0 |
2/S |
0 |
3/S/A |
|
87 |
0 |
0 |
0 |
1/S |
|
88 |
0 |
0 |
0 |
0 |
|
89 |
0 |
0 |
0 |
0 |
|
90 |
- |
- |
- |
- |
LF : left flank (vehicle)
RF : right flank (test item at the concentration of 10% (w/w))
S : dryness of the skin
- : dead animal
A : crusts
In order to determine whether the observed cutaneous reactions are attributable to delayed contact hypersensitivity or to an irritant effect of the test item, a second challenge application was performed. For this second challenge application, lower concentrations (1% and 5% (w/w)) were chosen.
Results second challenge application:
Control group 1 |
|||||||
Sex |
Animal |
Before treatment |
24 hours |
48 hours |
|||
|
number |
LF |
RF |
LF |
RF |
LF |
RF |
Male |
61 |
0 |
0 |
1 |
0 |
0 |
0 |
|
62 |
0 |
0 |
0 |
0 |
0 |
0 |
|
63 |
0 |
0 |
1 |
0 |
0 |
0 |
|
64 |
0 |
0 |
0 |
0 |
0 |
0 |
|
65 |
0 |
0 |
0 |
0 |
0 |
0 |
Female |
76 |
0 |
0 |
0 |
0 |
0 |
0 |
|
77 |
0 |
0 |
0 |
0 |
0 |
0 |
|
78 |
0 |
0 |
1 |
0 |
0 |
0 |
|
79 |
0 |
0 |
0 |
0 |
0 |
0 |
|
80 |
0 |
0 |
0 |
0 |
0 |
0 |
Treated group 1 |
|||||||
Sex |
Animal |
Before treatment |
24 hours |
48 hours |
|||
|
number |
LF |
RF |
LF |
RF |
LF |
RF |
Male |
66 |
0 |
0 |
0 |
0 |
0 |
0 |
|
67 |
0 |
0 |
0 |
0 |
0 |
0 |
|
68 |
0 |
0 |
0 |
0 |
0 |
0 |
|
69 |
0 |
0 |
0 |
0 |
0 |
0 |
|
70 |
0 |
0 |
0 |
0 |
0 |
0 |
|
71 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
1 |
0 |
1 |
0 |
|
73 |
0 |
0 |
0 |
0 |
0 |
0 |
|
74 |
0 |
0 |
0 |
0 |
0 |
0 |
|
75 |
0 |
0 |
0 |
0 |
0 |
0 |
Female |
81 |
0 |
0 |
0 |
0 |
0 |
0 |
|
82 |
0 |
0 |
0 |
0 |
0 |
0 |
|
83 |
- |
- |
- |
- |
- |
- |
|
84 |
0 |
0 |
0 |
0 |
0 |
0 |
|
85 |
0 |
0 |
0 |
0 |
0 |
0 |
|
86 |
0 |
0 |
2 |
0 |
1/S |
0 |
|
87 |
0 |
0 |
0 |
0 |
0 |
0 |
|
88 |
0 |
0 |
0 |
0 |
0 |
0 |
|
89 |
0 |
0 |
0 |
0 |
0 |
0 |
|
90 |
- |
- |
- |
- |
- |
- |
Control group 3 |
|||||||
Sex |
Animal |
Before treatment |
24 hours |
48 hours |
|||
number |
LF |
RF |
LF |
RF |
LF |
RF |
|
Male |
181 |
0 |
0 |
0 |
0 |
0 |
0 |
|
182 |
0 |
0 |
0 |
0 |
0 |
0 |
|
183 |
0 |
0 |
0 |
0 |
0 |
0 |
|
184 |
0 |
0 |
0 |
0 |
0 |
0 |
|
185 |
0 |
0 |
0 |
0 |
0 |
0 |
Female |
186 |
0 |
0 |
0 |
0 |
0 |
0 |
|
187 |
0 |
0 |
0 |
0 |
0 |
0 |
|
188 |
0 |
0 |
0 |
0 |
0 |
0 |
|
189 |
0 |
0 |
0 |
0 |
0 |
0 |
|
190 |
0 |
0 |
0 |
0 |
0 |
0 |
LF : left flank (test item at the concentration of 5% (w/w))
RF : right flank (test item at the concentration of 1% (w/w))
S : dryness of the skin
- : dead animal
The cutaneous reactions were as follows:
Control group 1
On the left flank (test item at the concentration of 5%), a discrete erythema (grade 1) was noted in 3/10 animals at the 24-hour reading only.
On the right flank (test item at the concentration of 1%), no cutaneous reaction was recorded.
Treated group 2
On the left flank (test item at the concentration of 5%), a discrete or moderate erythema (grade 1 or 2) was observed in 2/18 animals at the 24-hour reading. A discrete erythema (grade 1), together with dryness of the skin in one animal, persisted at the 48-hour reading in these two animals.
On the right flank (test item at the concentration of 1%), no cutaneous reaction was noted.
Control group 3
No cutaneous reaction was recorded.
The persistent cutaneous reactions observed in 2/18 animals of the treated group after the second challenge application may be attributable to delayed contact hypersensitivity.
Conclusion:
Under our experimental conditions and according to the maximization method of Magnusson and Kligman, the test item INIPOL 002 (batch No. 11638106) induces cutaneous reactions which could be attributable to delayed contact hypersensitivity in 2/18 (11%) guinea pigs and should therefore be considered as a mild sensitizer.Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Testing of Oleyl-diamine, dioleate in a GPMT study resulted to positive reactions in 2/19 (11%) Guinea pigs. According to classification criteria, no classification is required.
- Executive summary:
At the request of CECA SA, Paris-la-Défense, France, the potential of the test item INIPOL 002 (batch No. 11638106) to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD (No. 406, 17th July 1992) and EC (96/54/EEC, B.6, 30 July 1996) guidelines.
The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
Methods
Thirty guinea pigs were allocated to two groups: a control group 1 of five males and five females and a treated group 2 of ten males and ten females. An additional control group of five males and five females (group 3) was also used for the second challenge application.
On day 1, three pairs of intradermal injections were performed in the interscapular region of all animals:
• Freund's complete adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (groups 1 and 2),
• test item at the concentration of 0.1% in corn oil (treated group) or vehicle alone (control group 1),
• test item at the concentration of 0.1% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl (50/50, v/v) (control group 1).
On day 8, the animals of the treated group received a topical application of the test item at the concentration of 25% (w/w) in acetone to the same test site, which was then covered by an occlusive dressing for 48 hours. The animals of the control group 1 received an application of vehicle under the same experimental conditions.
On day 22, all animals of groups 1 and 2 were challenged by a cutaneous application of the test item at the concentration of 10% (w/w) in acetone to the right flank. The test item was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the left flank under the same experimental conditions. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.
As equivocal cutaneous reactions were noted after the first challenge, a second challenge application was performed on day 40 with the original control and treated groups and with a new control group of ten animals (group 3), which was free from any previous treatment. The test item was applied at the concentrations of 5% (w/w) to the median left flank and 1% (w/w) in acetone to the median right flank of the animals of all groups, under the same experimental conditions as for the first challenge application.
At the end of the study, the animals were killed without examination of internal organs.
No skin samples were taken from the challenge application sites.
Results
No systemic clinical signs and no deaths related to treatment were noted during the study.
After the first challenge application, in the control group, a discrete or moderate erythema was observed at the 24-hour reading in 1/10 and 2/10 animals, respectively. At the 48-hour reading, a discrete or moderate erythema, together with dryness of the skin in two animals, was recorded in 3/10 and 2/10 animals, respectively.
In the treated group, at the 24-hour reading, a discrete or moderate erythema, together with dryness of the skin in one animal, was noted in 6/18 and 1/18 animals, respectively. At the 48-hour reading, a discrete, moderate or intense erythema, together with dryness of the skin in five animals and crusts in one animal, was observed in 5/18, 4/18 and 1/18 animals, respectively.
After the second challenge application, the cutaneous reactions were as follows:
Control group 1
On the left flank (test item at the concentration of 5%), a discrete erythema was noted in 3/10 animals, at the 24-hour reading only.
On the right flank (test item at the concentration of 1%), no cutaneous reaction was recorded.
Treated group 2
On the left flank (test item at the concentration of 5%), a discrete or moderate erythema was observed in 2/18 animals at the 24-hour reading. A discrete erythema, together with dryness of the skin in one animal, persisted at the 48-hour reading in these two animals.
On the right flank (test item at the concentration of 1%), no cutaneous reaction was noted.
Control group 3
No cutaneous reaction was recorded.
The persistent cutaneous reactions observed in 2/18 animals of the treated group after the second challenge application may be attributable to delayed contact hypersensitivity.
Conclusion
Under our experimental conditions and according to the maximization method of Magnusson and Kligman, the test item INIPOL 002 (batch No. 11638106) induces cutaneous reactions which could be attributable to delayed contact hypersensitivity in 2/18 (11%) guinea pigs and should therefore be considered as a mild sensitizer.
However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be considered as a skin sensitizer.
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