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EC number: 203-916-0 | CAS number: 111-86-4
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1987
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Unsuitable test system (not suitable to detect weak sensitisers), challenge dose seems too high
- Principles of method if other than guideline:
- Mouse ear swelling test
- GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breding Laboratories, Kingston, NY
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 20-22 grams
- Housing: in groups of 2 to 5
- Diet: Purina Laboratory Chow # 5001, ad libitum
- Water: municipal water supply, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 67-76°F
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- Induction: 1.0% v/v
Challenges: 10% v/v - Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- Induction: 1.0% v/v
Challenges: 10% v/v - No. of animals per dose:
- 20
- Details on study design:
- Induction and challenge schedule:
FCA administration: 50% FCA; 20 µL administered to two sides f the abdomen, by intradermal injection
Induction: 1 % active substance open epicutaneous ; 100 µL, on days 1, 2, and 3
Challenge: 10 % active substance open epicutaneous; 10 µL to both the ventral and the dorsal surface of the left ear - Positive control substance(s):
- yes
- Remarks:
- DCNB
- Positive control results:
- Positive, performed as expected
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Octylamine was negative in the MEST. The MEST is, however, not able to identify weak sensitizers. It is therefore concluded that octylamine lacks strong sensitizing properties.
- Executive summary:
N-octylamine was negative in a Mouse Ear Swelling Test (MEST) using two groups of 10 treated mice each. The open epicutaneous induction concentration was 1% octylamin, the challenge concentration was 10%. Negative controls and the positive control animals (1% DCNB) performed as expected.
The mouse-ear swelling test (MEST) serves as a screen to detect potent sensitisers (moderate and strong ones). Weak sensitisers are unlikely to be detected in this test. According to EPA guideline OPPTS 870.2600, a negative result in the MEST does not indicate that the substance is a nonsensitizer, and should be confirmed in an accepted test using guinea pigs and or LLNA if appropriate. The test provided no evidence of a sensitising potential of n-octylamine. Also all other amines tested gave no positive response. The functionality of the test system was demonstrated by using an appropriate positive control substance which was clearly positive. Despite the limited number of animals used and the test restrictions, the result can be weighed in relation to the positive control, the dose used to provoke an effect and the negative result obtained with three structure-related primary amines (cyclohexylamine, hexylamine, isopropylamine). Hence, n-octylamine is not considered to be a potent sensitiser and unlikely to elicit a skin allergic reaction (Hoechst, 1987).
Reference
POSITIVE CONTROL:
80 and 100 % of the animals showed a positive response (at least 20 % increase in ear thickness) after 24 and 48 h, respectively.
TEST GROUP:
Few animals challenged with the TS showed weakly positive reactions at challenge or re-challenge in either the test group or
in the irritation control group: The incremental increases in ear thickness ranged from 0 - 10 %.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
N-octylamine was negative in a Mouse Ear Swelling Test (MEST) using two groups of 10 treated mice each. The open epicutaneous induction concentration was 1% octylamin, the challenge concentration was 10%. Negative controls and the positive control animals (1% DCNB) performed as expected.
The mouse-ear swelling test (MEST) serves as a screen to detect potent sensitisers (moderate and strong ones). Weak sensitisers are unlikely to be detected in this test. According to EPA guideline OPPTS 870.2600, a negative result in the MEST does not indicate that the substance is a nonsensitizer, and should be confirmed in an accepted test using guinea pigs and or LLNA if appropriate. The test provided no evidence of a sensitising potential of n-octylamine. Also all other amines tested gave no positive response. The functionality of the test system was demonstrated by using an appropriate positive control substance which was clearly positive. Despite the limited number of animals used and the test restrictions, the result can be weighed in relation to the positive control, the dose used to provoke an effect and the negative result obtained with three structure-related primary amines (cyclohexylamine, hexylamine, isopropylamine). Hence, n-octylamine is not considered to be a potent sensitiser and unlikely to elicit a skin allergic reaction (Hoechst, 1987).
Not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008. N-octylamine was negative in a Mouse Ear Swelling Test (MEST) and is therefore unlikely to have strong or moderate sensitising properties. A weak sensitiser test is not required because of the skin corrosion effects (Annex VII, 8.3, column 2).
Migrated from Short description of key information:
N-octylamine was negative in a Mouse Ear Swelling Test (MEST) and is therefore unlikely to have strong or moderate sensitising properties. A weak sensitiser test is not required because of the skin corrosion effects.
Justification for selection of skin sensitisation endpoint:
only experimental study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the criteria set in Regulation (EC) No 1272/2008 a classification for skin sensitisation is not required as available data do not indicate a skin sensitising property.
Additionally, according to REACH Annex VII section 8.3 column 2 skin sensitisation studies (in vitro and in vivo) do not need to be conducted if the substance is classified as skin corrosion. Since this criteria is fulfilled, no additional studies are required.
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