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Diss Factsheets
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EC number: 701-175-2 | CAS number: -
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Buehler (Ritz and Buehler, 1980)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This substance has been demonstrated to be a non-sensitizer in a guideline compliant studies, therefore potency data as generated in an LLNA is not needed.
Test material
- Reference substance name:
- Amines, C10-C14-tert-alkyl
- EC Number:
- 701-175-2
- Cas Number:
- 68955-53-3
- Molecular formula:
- C10H23N to C14H31N
- IUPAC Name:
- Amines, C10-C14-tert-alkyl
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
- Source: Charles River Kingston, Stone Ridge, New York
- Age at study initiation: not reported
- Weight at study initiation: 426 - 632 g
- Housing: 1/cage in wire mesh cages
- Diet (e.g. ad libitum): ad libitum, Purina guinea pig chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 to 75 degrees C
- Humidity (%): 48-66%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: August 20, 1984 To: September 26, 1984
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.4 mL of a 3.0% w/v ethanol solution induction
0.4 mL of a 1.0% w/v in acetone challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.4 mL of a 3.0% w/v ethanol solution induction
0.4 mL of a 1.0% w/v in acetone challenge
- No. of animals per dose:
- 30
- Details on study design:
- RANGE FINDING TESTS: Range finding skin irritation tests were conducted on 16 naive guinea pigs to determine the slightly irritating concentration (SIC) to be used for induction and the highest non-irritating concentration (HNIC) to be used for challenge. Eight concentrations: 50%, 25%, 12.5%, 6.0%, 3.0%, 1.0%, 0.5% and 0.25% w/v test material in absolute ethanol and the same concentrations in acetone were applied to the skin sites. The application sites were changed among the guinea pigs for each of the above concentrations to minimize any site-to-site variation in irritation response.
The range-finding primary skin irritation tests results on 32 naïve guinea pigs were 3% in absolute ethanol for induction and 1% in acetone for challenge.
RESULTS OF TEST -
Sensitization reaction:
Induction Incidence Irritation/Sensitization
24 hr 48 hr
3% (w/v) in ethanol 0/10 (0.2) 0/10 (0.1)
Challenge
1% in acetone 15/19 (1.4) 10/19 (0.7)
Note: the value in parenthesis represents the mean dermal score (i.e., the intensity of the irritation response) - Clinical signs: At a challenge concentration of 1% test material in acetone, 15 of the 19 guinea pigs induced with test material responded with erythema of grade 1 or greater while none of the non-induced guinea pigs responsed with erythema of grade 1 or greater.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: three 6 hr periods per week for 3.5 consecutive weeks
- Test groups: 19 guinea pigs
- Control group: yes; receiving SHAM treatment during induction
- Site: back of the guinea pigs
- Frequency of applications: 10 applications over a 3.5 week period
- Duration: 6-hr
- Concentrations: 3.0%
B. CHALLENGE EXPOSURE- after a two-week rest period
- No. of exposures: 1
- Day(s) of challenge: 48 hours
- Exposure period: approximately 24 hours after the challenge application, the backs of the guinea pigs were depliated with NEET(R) lotion hair remover. The depilatory was liberally applied to the clipped application sites and allowed to remain on the animlas for approximately 20 minutes. The animals were then rinsed with lukewarm running tap water, blotted dry, and then returned to their cages.
- Test groups: 19 treated guinea pigs from the induction group and a group of 10 naive guinea pigs
- Control group: yes, from induction group
- Site: back of the guinea pigs
- Concentrations: 1.0% w/v test material
- Evaluation (hr after challenge):
OTHER: No rechallenge - Challenge controls:
- Non-induced challenge controls
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0% w/v in acetone
- No. with + reactions:
- 15
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0% w/v in acetone. No with. + reactions: 15.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0% w/v in acetone
- No. with + reactions:
- 10
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0% w/v in acetone. No with. + reactions: 10.0. Total no. in groups: 19.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0% w/v in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.0% w/v in acetone. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0% w/v in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0% w/v in acetone. No with. + reactions: 0.0. Total no. in groups: 19.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- Under these test conditions, the test material produced DCH in guinea pigs induced with the test material.
- Executive summary:
The delayed contact hypersensitivity *DCH potential of the test material was tested in young adult outbred Hartley guinea pigs (GP). Ten induction doses (0.4 ml) of 3.0% (W/V) test material in absolute ethanol were applied to the backs of an induction group of 9 male and 10 female GP for three 6 -hr periods per week for 3.5 consecutive weeks. Two weeks after the last induction treatment, the 19 GP in the induction group and a group of 10 naive control GP were each "challenged" with 0.4 ml of a 1.0% (W/V) solution of test material in acetone. Erythema reactions were scored at 24 and 48 hours after the challenge exposure. At a challenge concentration of 1.0% (W/V) test material in acetone, 15 of 19 test material induced GP responded with an erythema reaction of grade 1 or greater while no grade 1 or greater reactions were observed in the 10 non-induced controls. Under these test conditions, the test material produced DCH in guinea pigs induced with the test material.
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