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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
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Additional physico-chemical information
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- Endpoint summary
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- 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
Tallow-diamine dioleate is considered to be irritating to both skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 28 Jan 1986 - 11 Feb 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD 406 method.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- 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 - 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.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 01, 02, 03 (1 hour)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Skin dryness was shown reversible by day 13
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 01, 02, 03 (1 hour)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 04, 05, 06 (4 hours)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Skin dryness was reversible within 12 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 04, 05, 06 (4 hours)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- animals 04, 05, 06 (4 hours)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3.67
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Max score is theorethical maximum average score (erythema 4 + oedema 4)
- 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. - Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test substance was considered as irritant.
- 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
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- between 21 and 28 August 1984
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Morton Commercial Rabbits, Stansted, Essex
- Age at study initiation: approximately 9 to 11 weeks of age
- Weight at study initiation: 2.1 to 2.3 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not indicated; The rabbits selected for the study were all acclimated to the laboratory environment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: between 21 and 28 August 1984 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Eye were not flushed after installation.
- Observation period (in vivo):
- Observations post application at 1 hour and after 1, 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage or conjunctival inflammation.
A 0.1 ml aliquot of EN 455 was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: all animals reach avg score ≥1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: None of the animals reach an avg score ≥ 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: All animals reach avg score ≥ 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: All animals reach avg score ≥ 2
- Irritant / corrosive response data:
- The numerical scores awarded to the ocular reactions elicited by EN 455 are given in the table on ocular reactions.
All three animals gave a "positive" response.
Corneal opacities developed in all three animals.
Temporary iritis was seen in one animal.
A diffuse crimson red colouration of the conjunctivae was observed in all three animals and was accompanied by considerable swelling with partial eversion of the eyelids or with the eyelids about half-closed.
The eyes were normal seven days after instillation.
There were no other lesions. - Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Oleyl diamine, dioleate was irritating in the in vivo eye irritation test in rabbits. The effects were fully reversible within 7 days. The study results indicate that the substance should be classified Cat.2 irritating to the eyes for GHS.
- Executive summary:
The eye irritation potential of Oleyl diamine, dioleate was assessed in an in vivo eye irritation study in rabbits according to OECD 405, and in compliance with GLP.
A 0.1 ml aliquot of Oleyl diamine, dioleate was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
Examination of the eyes was made after 1 hour and 1, 2, 3, 4, and 7, days after instillation. Observation of the eyes was aided by the use of a handheld torch.
Results:
All three animals gave a "positive" response.
Corneal opacities developed in all three animals.
Temporary iritis was seen in one animal.
A diffuse crimson red colouration of the conjunctivae was observed in all three animals and was accompanied by considerable swelling with partial eversion of the eyelids or with the eyelids about half-closed.
The eyes were normal seven days after instillation.
There were no other lesions.
According the GHS criteria, these results indicate that the substance should be classified Cat.2 for eye irritation according to GHS.
Reference
Ocular reactions:
rabbit |
Region of Eye |
One hour |
Day after instillation |
Result |
|||||
1 |
2 |
3 |
4 |
7 |
|||||
960 (female) |
Cornea |
0 |
2 |
2 |
2 |
2 |
0 |
+ |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
||
Chemosis |
2 |
3 |
2 |
2 |
2 |
0 |
|||
961 (female) |
Cornea |
0 |
1 |
1 |
1 |
1 |
0 |
+ |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
||
Chemosis |
2 |
2 |
2 |
2 |
1 |
0 |
|||
978 (female) |
Cornea |
0 |
2 |
2 |
2 |
2 |
0 |
+ |
|
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
||
Chemosis |
2 |
3 |
2 |
2 |
2 |
0 |
Classification for GHS Cat.2 is fulfilled, as:
- at least 2 of the three animals show an mean (24, 48 and 72 hr) score for corneal opacity ≥ 1 (all three animals),
- at least 2 of the three a mean conjunctival redness of ≥ 2 (all three),
- at least 2 of the three a mean conjunctival chemosis of ≥ 2 (all three)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Dermal irritation:
There is data available on both Tallow-diamine dioleate and Oleyl-diamine dioleate.Cross-reading between the two substances is acceptable on the basis ofidentical chemicalstructures. The only differences between the two substances are related to the alkyl-chains linked to the diamine.Contrary to oleyl do tallow-alkyl chains also contain some C16-chains next to the C18-alkyl chains.The toxicological relevance of this diference is expected to be negligible. The higher level of unsaturation in oleyl-alkyl chainscompared to tallow-alkyl chainscan be considered a worst case representationwith respect to possible irritating properties whencompared to tallow. Due to this very great similarity between these two substances, results obtained from Oleyl-diamine dioleatearefully applicable for the evaluation of Tallow-diamine dioleate as well.
There are two studies available on Oleyl-diamine dioleate, both according to OECD 404 guidelines and in compliance to GLP.
In one study the acute dermal irritation of Oleyl-diamine dioleate was evaluated after application of 0.5 ml on the skin of 2 groups of 3 NZW rabbits for 1 hour, respectively for 4 hours.
One hour after removal, the signs of dermal irritation were very weak in the animals receiving the test substance during one hour, and moderate in the other animals. During the further observation days, 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 only.
The severest reaction was seen in one animal in the 4-hour group, with a grade 4 reaction for both erythema and oedema 3 and 4, and then gradually decreased and was completely resolved by day 9.
On day 9 only skin dryness was noted in 5/6 animals, and over the days was observed in less animals, and was completely cleared on day 13.
ECETOC evaluated the data and concluded to a Primary Irritation Index of 3.67 for the three animals that were exposed for 4 hours.
The substance was concluded to be irritating to the skin.
An additional available study evaluated the skin irritation potential of Oleyl-diamine dioleate, in rabbits. A 0.5 ml aliquot of Oleyl-diamine dioleate was applied under a 2.5 cm square gauze pad to one intact skin site on each of three animals under semi-occlusive dressing for four hours.
At the end of the exposure period, the dressing and pad were removed and the treatment site was washed using distilled water to remove any residual test substance. Observations were done approximately 30 minutes after removal of the patches, and then daily until day 6.
Very slight erythema was observed in all three animals following removal of the bandages, and very slight erythema with slight oedema was seen in all three animals on Days 2 and 3. These reactions gradually ameliorated and the skins were normal by day 5 or 6.
As none of the mean scores for erythema or oedema during three consecutive days was 2.3 or higher, the substance does not need to be classified as skin irritant Cat. 2 for GHS.
An older study with Tallow-diamine dioleate resulted to clear irritation, but also indication of possible corrosive effects. However, no observations were performed after 96 hrs, and for these substances it known that they can result to severe inflammatory reactions that often interpreted as corrosive, but which show complete recovery upon extended observations. In view of this, it is noteworthy that for 4 of the 6 animals improvements were already seen at 96 hours compared to 48 hours.
Additionally, the report is of limited validity due to shortcomings in study design and reporting.
On overall the available data show mixed results between no need for classification as irritant and possibly even corrosive. The most reliable study of the three concludes to irritant, and this is also considered as the best conclusion based on all available information. Also the available eye irritation study did not show corrosive effects.
Additional considerations:
- Definition of corrosion for classification:
A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to a 4 hour duration. Corrosive reactions are typified by ulcers, bleeding, bloody scabs and, by the end of observation at 14 days, by discoloration due to blanching of the skin, complete areas of alopecia and scars.
- No real fixed line between very severe irritation and corrosive effects:
The definition indicates for corrosion effects as "ulcers, bleeding, bloody scabs" should be seen, and by end of 14 day observation "blanching of the skin and scars". However, 'bleeding ulcers' and 'bloody scabs' are rarely observed, and in case very severe reactions indicative for necrosis, the study will be terminated for humane reasons, rather than complete the full observation period.
The study on Tallow-diamine dioleate did not extend observations beyond day 4 because of the severity of the reactions and there is a possibility that recovery could have occurred when the observation was prolonged. However, based on the very severe reactions, the decision to terminate the study was correct in view of animal welfare.
- Decontamination of the skin.
These substances are rather sticky to the skin, and will not easily be
washed off with pouring some water over it. This could play also a role
in view of the observations that reactions can take a longer time to
develop. Possibly, cleaning in the studies on Oleyl-diamine dioleate was
more efficient. Consequently, it is possible that this difference of
substance removal plays a role in the observed difference in severity of
reactions.
- Number of animals:
Even in case of testing with three animals, if corrosive effects are
observed in one animal, classification is appropriate. In one
Oleyl-diamine dioleate study, there is at least one animal that shows
severe reactions resulting to the highest scoring, which is the same as
the scoring of all three animals in the study with Tallow-diamine
dioleate. There were no clear signs of necrosis, although this
observation might have been differently evaluated when the other two
animals also showed these very severe reactions.
Eye irritation:
The eye irritation potential of Oleyl-diamine dioleate was assessed in an in vivo eye irritation study in rabbits according to OECD 405, and in compliance with GLP.
A 0.1 ml aliquot of Oleyl diamine, dioleate was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
Corneal opacities developed in all three animals and temporary iritis was seen in one animal.
A diffuse crimson red colouration of the conjunctivae was observed in all three animals and was accompanied by considerable swelling with partial eversion of the eyelids or with the eyelids about half-closed. The eyes were normal seven days after instillation. There were no other lesions.
Respiratory irritation:
Tallow-diamine dioleate is a solid at 20°C with a melting point of 38 °C. It has avapour pressure less than 0.0015 Pa at 20°C (value is an overestimation as it is based on read-across from C12-14-diaminerather than a dioleic acid salt of an alkyl diamine as Tallow-diamine dioleate salt).Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected.
Justification for selection of skin irritation / corrosion endpoint:
Most reliable study available.
Justification for selection of eye irritation endpoint:
Only available study
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
It is proposed to follow the results from the most reliable studies that are available for both Oleyl-diamine dioleate and Tallow-diamine dioleate, and classify for irritation.
Consequently, GHS classification Cat.2 skin irritation is appropriate, with hazard statement H315: Causes skin irritation.
In view of the irritant properties, Tallow-diamine dioleate should be classified Cat.2 for eye irritation according to GHS, with hazard statement H319: Causes serious eye irritation.
STOT-SE Cat.3 for respiratory irritation is not required. Exposure to via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected.
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