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EC number: 272-347-8 | CAS number: 68814-95-9
- 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
Skin:
- Skin irritation, Rabbit, 4h, OECD 404, RA from CAS 1116-76-3: severe reaction, erythema score 3.8 (average per animal: 3.7, 4.0, 3.7) and oedema score 2.6 (3.0, 2.7, 2.0), fully reversible within 15d in 2 of 3 cases (BASF SE, 1988, 18H0264/882108)
Eye:
- Eye irritation, Rabbit, OECD 405, RA from CAS 1116-76-3: slight to mild signs (cornea, iris and chemosis score are 0, redness of conjunctiva 1.7 (1, 2, 2). Fully reversible within 8 days. (BASF SE, 1988, 11H0264/882109)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, with acceptable restrictions (no data on test substance purity)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- (test design not in accordance with sequential testing strategy as laid down in the Supplement of the recent version of the OECD TG 404 (2002))
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach, Germany
- Age at study initiation: no data
- Weight at study initiation: male rabbits (mean): 2.63 kg; female rabbit 2.87 kg
- Housing: single
- Diet (ad libitum): Kliba 341, 4 mm, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (ad libitum): tap water (about 250 mL per animal per day)
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated dorsal skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3 animals (2 males, one female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, upper third of the back or flanks
- Type of wrap: test patches were secured in position with a porous dressing (4 layers of absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize scoring system
READINGS:
Readings of skin reactions were performed 30 - 60 min after removal of the test patches and then 24 h, 48 h, 72 h, 8 d, and 15 d after the beginning of application. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Erythema and scaling beyond the area of application at study termination
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: Scaling beyond area of application at study termination
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: Scaling at study termination
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Results:
Readings |
Animal No. |
Erythema |
Edema |
Additional findings |
4 h |
1 |
2 |
0 |
- |
2 |
2 |
1 |
- |
|
3 |
2 |
1 |
- |
|
24 h |
1 |
3 |
4 |
findings (ery., ed.) extending beyond the area of application |
2 |
4 |
3 |
findings (ery., ed.) extending beyond the area of application |
|
3 |
3 |
3 |
findings (ery., ed.) extending beyond the area of application |
|
48 h |
1 |
4 |
3 |
findings (ery., ed.) extending beyond the area of application |
2 |
4 |
3 |
findings (ery., ed.) extending beyond the area of application |
|
3 |
4 |
2 |
findings (ery., ed.) extending beyond the area of application |
|
72 h |
1 |
4 |
2 |
findings (ery., ed.) extending beyond the area of application |
2 |
4 |
2 |
findings (ery., ed.) extending beyond the area of application |
|
3 |
4 |
1 |
findings (ery., ed.) extending beyond the area of application |
|
8 d |
1 |
2 |
2 |
findings (ery., ed.) extending beyond the area of application, superficial scabbing extending beyond the area of exposure, hemorrhage |
2 |
2 |
1 |
findings (ery., ed.) extending beyond the area of application, superficial scabbing extending beyond the area of exposure |
|
3 |
2 |
1 |
findings (ery., ed.) extending beyond the area of application, superficial scabbing extending beyond the area of exposure |
|
15 d |
1 |
1 |
0 |
findings (ery., scaling) extending beyond the area of application |
2 |
0 |
0 |
findings (scaling) extending beyond the area of application |
|
3 |
0 |
0 |
scaling |
|
mean (24 - 48 - 72 h readings) |
1 |
3.7 |
3.0 |
n.a. |
2 |
4.0 |
2.7 |
n.a. |
|
3 |
3.7 |
2.0 |
n.a. |
n.a.: not applicable
ery.: erythema
ed.: edema
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, with acceptable restrictions (no data on test substance purity)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- (test design not in accordance with sequential testing strategy, no systemic or ocular anesthetic used as laid down in the Supplement of the recent version of the OECD TG 405 (2012))
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Savo, Med. Versuchstierzuchten GmbH, D-7964 Kissleg, Germany
- Age at study initiation: no data
- Weight at study initiation: mean: 2.91 kg
- Housing: single
- Diet (ad libitum): Kliba 341, 4 mm; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (ad libitum): tap water (about 250 mL per animal per day)
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eyes of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single application to the conjunctival sac of the right eye lid; the substance was not washed out
- Observation period (in vivo):
- 8 d
(The study was discontinued after 8 days, since all eye reactions had subsided.) - Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: no data
READINGS:
Readings of eye reactions were performed 1 h, 24 h, 48 h, 72 h, and 8 days after application. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (of 3 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (of 3 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (of 3 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance shows slight to mild eye reactions leading to cat 2 classification according to CLP.
- Executive summary:
Tri-N-Octylamin was tested for acute irritation effects on eyes according to OECD 405 by single dose application (0.1ml) to the conjunctival sac of 3 male Vienna White rabbits (BASF SE, 1988, 11H0264/882109) to of three rabbits (Kleinrussen, Chbb:HM) with a single dose of 0.1 g per conjunctival sac and a duration of exposure of 24 hours. The mean cornea score and iris score was 0 (mean of all animals and timepoints). The mean chemosis score was recorded as 0, whereas slight to mild conjunctiva reactions (redness) were observed with gradings 1, 2, 2 (animal#1, animal#2, animal#3, average of 24/48 and 72 h reading) According to the test conditions the test substance has to be classified as irritating to eye cat 2 GHS.
Reference
Results:
Time |
Rabbit no. |
Cornea |
Iris |
Conjunctivae |
Additional findings |
|||
|
|
Opacity |
Area |
|
Redness |
Chemosis |
Discharge |
|
1 h |
1 |
0 |
0 |
0 |
2 |
0 |
1 |
- |
2 |
0 |
0 |
0 |
2 |
0 |
1 |
- |
|
3 |
0 |
0 |
0 |
2 |
0 |
1 |
- |
|
24 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
- |
|
3 |
0 |
0 |
0 |
2 |
0 |
0 |
- |
|
48 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
- |
|
3 |
0 |
0 |
0 |
2 |
0 |
0 |
- |
|
72 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
- |
|
3 |
0 |
0 |
0 |
2 |
0 |
1 |
- |
|
8 d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Loss of hair at margins of eyelids |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Loss of hair at margins of eyelids |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
Loss of hair at margins of eyelids |
|
mean (24-48-72 h) |
1 |
0 |
0 |
0 |
1.0 |
0 |
- |
- |
2 |
0 |
0 |
0 |
2.0 |
0 |
- |
- |
|
3 |
0 |
0 |
0 |
2.0 |
0 |
- |
- |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No valid study are data available assessing the skin or eye irritation in vivo of Amines, tri-C8-10-alkyl. Nevertheless there are information from a “semi” read across substance Amines, tri C8 alkyl (CAS 1116-76-3) containing only C8 C-chains. As the substance registered here contains also C8 chains but partly C10 chains the structures are assumed to very similar and partly the same. Therefore the suitability of a read across to the pure C8 chain alkyl amine is assumed and comparable toxicological behaviour is expected. As both structures are that similar no further separate analogue document is created.
Skin:
In vivo OECD guideline conform studies:
A study of the skin irritant effect was performed with Tri-N-Octylamin according to OECD No 404 (1992); EEC 92/69 - Annex V/B5 (1992) (BASF SE, 1988, 18H0264/882108).
Therefore 3 Vienna white rabbits (2male, 1female) where exposed for 4h to 0.5ml undiluted test material (Tri-N-Octylamine). After 4h the semi occlusive coverage was removed and the application site washed with Lutrol/Water. Readings were taken 30-60min after removal and 24h, 48h, 72h and as well as 8d and 15d after removal. The untreated area of each animal serves as control.
The 24/48/72 hours average scores of all animals was 3.8 (average per animal: 3.7, 4.0, 3.7) for erythema and 2.6 (3.0, 2.7, 2.0) for oedema.
In animal#1 the reaction was redness was not fully reversible within 15 days, whereas all other animals did not show any reaction (erythema or edema) on day 15.
In result the substance was severely irritating to skin.
Key study assignment skin irritation:
As there is only information from a study conducted with a read across substance, but this substance is a strong homologue and therefore assumed to be comparable in toxicological behaviour, this study is used assessing the skin irritation of Amines, tri-C8-10-alkyl and integrated as key study.
Assessment skin irritation:
All available information is taken into account to assess the skin irritating potential of Amines, tri-C8-10-alkyl. As there is no study with the registered substance available a close structural homologue substance (Tri-N-Octylamin) is used as read across. It can be assumed that Tri-N-Octylamin and Amines, tri-C8-10-alkyl are comparable in toxicological behaviour. Therefore the results from a skin irritation test with Tri-N-Octylamin are used to assess the skin irritation potential of Amines, tri-C8-10-alkyl. Based on the grading received from the animal study, Amines, tri-C8-10-alkyl is assumed to be severe irritating to skin. The recorded grading were very high but in all cases, except one, reversible within 15 days. Therefore the substance has to be classified as skin irritating cat 2 according GHS.
Eye irritation:
OECD guideline conform studies:
Tri-N-Octylamin was tested for acute irritation effects on eyes according to OECD 405 by single dose application (0.1ml) to the conjunctival sac of 3 male Vienna White rabbits (BASF SE, 1988, 11H0264/882109) to of three rabbits (Kleinrussen, Chbb:HM) with a single dose of 0.1 g per conjunctival sac and a duration of exposure of 24 hours. The mean cornea score and iris score was 0 (mean of all animals and timepoints). The mean chemosis score was recorded as 0, whereas slight to mild conjunctiva reactions (redness) were observed with gradings 1, 2, 2 (animal#1, animal#2, animal#3, average of 24/48 and 72 h reading). The effects observed were fully reversible within 8 days. According to the test conditions the test substance has to be classified as irritating to eye cat 2 GHS.
Key study assignment eye irritation:
As there is only information from a study conducted with a read across substance, but this substance is a strong homologue and therefore assumed to be comparable in toxicological behaviour, this study is used assessing the eye irritation of Amines, tri-C8-10-alkyl and integrated as key study.
Assessment eye irritation:
All available information is taken into account to assess the skin irritating potential of Amines, tri-C8-10-alkyl. As there is no study with the registered substance available a close structural homologue substance (Tri-N-Octylamin) is used as read across. It can be assumed that Tri-N-Octylamin and Amines, tri-C8-10-alkyl are comparable in toxicological behaviour. Therefore the results from a eye irritation test with Tri-N-Octylamin are used to assess the eye irritation potential of Amines, tri-C8-10-alkyl. As cornea, iris and chemosis score are 0 and only slight to mild redness of conjunctivae (scores between 1 and 2) the substance has to classified as irritating to skin cat. 2 GHS.
Effects on skin irritation/corrosion: highly irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Skin:
Based on the available information from skin irritation study were gradings between 2.3 and 4 are observed, the substance has to be classified according to EU, UN-GHS (EC 1272/2008 ) as skin irritating Cat. 2 or DSD (67/548/EEC) R38
Labelling for skin irritation:
GHS: skin irritating Cat. 2
DSD: skin irritating R38
Eye:
Based on the available information from eye irritation study the test substance has to be classified according to Regulation No (EC) 1272/2008 (CLP) as eye irritant cat 2A or according to Directive 67/548/EEC (DSD) criteria as R36.
Labelling for eye irritation:
GHS: eye irritating Cat 2A
DSD: eye irritating R36
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.