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EC number: 251-846-4 | CAS number: 34140-91-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jan 1986 - 11 Feb 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
- Reference Type:
- secondary source
- Title:
- Skin irritation and corrosion: Reference Chemicals Data Bank
- Author:
- ECETOC TF
- Year:
- 1 995
- Bibliographic source:
- ECETOC Technical Report No. 66, MArch 1995, ISSN-0773-8072-66
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
- EC Number:
- 251-846-4
- EC Name:
- Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
- Cas Number:
- 34140-91-5
- Molecular formula:
- C21H44N2.2C18H34O2
- IUPAC Name:
- oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
- Test material form:
- liquid: viscous
- Details on test material:
- Chemical registery number : CAS 34140-91-5 / EC 251-846-4
Chemical name : N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Age at study initiation: not indicated
- Weight at study initiation: mean weigh 2.6 kg
- Housing: individually housed in polystyrene cages 0.35 x O.55 x 0.32 m.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): not stated: The inconing, non recycled air, was filtered by an absolute filter.
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 Jan 1986 To: 11 Feb 1986
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: non-exposed left flank served as control
- Amount / concentration applied:
- 0.5 mL on approx. 6 cm2 on right flank animal
- Duration of treatment / exposure:
- 3 animals for 1 hour, and 3 additional animals for 4 hours.
Residual test substance was removed by means of a gauze saturated with sterile pyrogen-free water. - Observation period:
- 14 days
- Number of animals:
- 3 per exposure duration of 1 hour and 4 hours
- Details on study design:
- A dose of 0.5 ml was applied to the clipped area 6 cm2 wide of the right flank of each animal. The treated area was then covered with a hydrophilic gauze patch to prevent loss of test substance. The test substance and the gauze patch were held in contact with the skin using a semi-occluslve patch adhesive tape.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (1 hour)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Skin dryness was shown reversible by day 11
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (1 hour)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Skin dryness was shown reversible by day 13
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (1 hour)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Skin dryness was shown reversible by day 11
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (1 hour)
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (1 hour)
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (1 hour)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- (4 hours)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Skin dryness was shown reversible by day 11
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- (4 hours)
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Skin dryness was shown reversible by day 11
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- (4 hours)
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: Skin dryness was shown fully reversible by day 12
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- (4 hours)
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- (4 hours)
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- (4 hours)
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- See scoring table.
The reactions were a bit more marked during the observation period in the animals receiving the test substance during four hours than in those receiving the test substance during one hour.
The report concludes that the test substance INIPOL 002 was considered as irritant however the criteria to classify as skin irritatnt according to CLP regulation (2015) are not satisfied.
Any other information on results incl. tables
Evaluation of skin reactions
|
|
Observation time after exposure |
|||||||||||||
|
|
hours |
days |
||||||||||||
|
Animal no. |
1 hr |
24 hr |
48 hr |
72 hr |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
Erythema |
01 |
0 |
2 |
2 |
2 |
2 |
2 |
1A |
1A |
0A |
0A |
0A |
0 |
0 |
- |
|
02 |
1 |
3 |
3 |
3 |
3 |
3 |
2A |
1A |
0A |
0A |
0A |
0A |
0A |
0 |
|
03 |
0 |
1 |
1 |
1 |
1 |
1 |
1A |
0A |
0A |
0A |
0A |
0 |
0 |
- |
|
04 |
2 |
2 |
3 |
4 |
4 |
4A |
3A |
2A |
1A |
0A |
0A |
0 |
0 |
- |
|
05 |
1 |
2 |
2 |
1 |
1 |
1 |
1A |
0A |
- |
- |
- |
- |
0 |
- |
|
06 |
2 |
2 |
2 |
1 |
1 |
1 |
0A |
0A |
0A |
0A |
0A |
0A |
0 |
- |
Oedema |
01 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
02 |
0 |
2 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
04 |
2 |
3 |
3 |
4 |
4 |
4 |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
- |
|
05 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
- |
0 |
- |
|
06 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
A: Skin dryness
- : Animals without dermal reaction were not recorded any more.
Animals no. 01, 02, 03: Contact duration 1 hour
Animals no. 04, 05, 06: Contact duration 4 hours
Applicant's summary and conclusion
- Interpretation of results:
- other: not iclassified according to CLP Criteria
- Conclusions:
- The test substance was considered as irritant according to ECETOC but not according CLP criteria.
- Executive summary:
The acute dermal irritation of the test substance INIPOL 002 was evaluated after application of 0.5 ml on the skin of six New-Zealand white rabbits divided into two groups of three animals. The test substance was removed after one hour in one group and after four hours in the other group by means of a gauze patch saturated with sterile pyrogen-free water.
One hour after removal of the gauze patch, the signs of dermal irritation were very weak in the animals receiving the test substance during one hour, and moderate in the other animals.
After 24 hours, the signs of irritation were similar and moderate in both groups. They were marked in one animal on day 3 and day 4.
On day 4 an erythema associated with a severe oedema was observed in one animal, as well as a moderate to severe erythema in one animal, a well defined erythema in one animal, a very slight erythema in three animals, and a very slight oedema in two animals.
Oedema lasted until day 8 in one animal.
The erythema noted on day 4 persisted on day 6, and then had disappeared on day 8 in three animals and on day 9 in the last two animals.
On day 9 only skin dryness was noted in 5/6 animals and over the days was observed in less animals, and completely cleared on day 13.
To sum up, the reactions were a bit more marked during the observation period in the animals receiving the test substance during four hours than in those receiving the test substance during one hour.
Under our experimental conditions, the test substance INIPOL 002 was considered as irritant.
ECETOC (Technical Report 66) evaluated this report and calculated the Primary Irritation Index for the three animals that were exposed for 4 hours:
PII = ( SUM Erythema 24/48/72hr + SUM Oedema 24/48/72hr)/ (3 x no. of animals) = 3.67
However the criteria to classify as skin irritant Cat. 2 according to CLP regulation (2015) are not satisfied.
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