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EC number: 701-204-9 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05/2002-03/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Existing study conducted before the LLNA requirement
Test material
- Reference substance name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- EC Number:
- 701-204-9
- Cas Number:
- 68784-17-8
- IUPAC Name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TS01007
Alkanoic acid amide
CAS#68784-17-8
- Expiration date of the lot/batch: 01/01/2003
- Description: Yellow to light amber viscous liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in USP grade mineral oil (vehicle)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, PA
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Only healthy animals chosen for study
- Age at study initiation: Approximately 7 and 9 weeks for males and females, respectively
- Weight at study initiation: Males (348-461); Females (336-429)
- Housing: individually in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 49-77%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: May 28, 2002 To: July 4, 2002
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 75%
- Day(s)/duration:
- Once a week for 3 consecutive weeks; chambers removed after 6 hrs
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- 1day/ 6 hr duration
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- 1 day/ 6 hr duration
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 10%
- Day(s)/duration:
- 1 day/ 6 hr duration
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- Following challenge with 25% w/w Alkanoic acid amide in USP mineral oil, dermal scores of 1 were noted in 4/20 test animals following the 24- and 48-hour scoring intervals. Dermal reactions in the remaining test, vehicle challenge control and naive challenge control animals were limited to scores of 0 to +/-.
Following rechallenge with 25% w/w Alkanoic acid amide in USP mineral oil, dermal scores of 1 were noted in 1/20 test animals following the 24- and 48-hour scoring intervals. Dermal reactions in the remaining test, vehicle rechallenge control and the naive rechallenge control animals were limited to scores of 0 to +/-.
Following rechallenge with 10% w/w Alkanoic acid amide in USP mineral oil, dermal reactions were limited to scores of 0 to " following the 24- and 48-hour scoring intervals.
At challenge, dermal scores of 1 or greater were observed in 4/20 animals at both the 24-hour and the 48-hour scoring intervals.
At rechallenge, dermal scores of 1 or greater were observed in 1/20 animals (same concentration as challenge) or 0/20 animals (lower concentration than challenge) at both the 24-hour and the 48-hour scoring intervals.
No animals responded at both challenge and rechallenge. - Challenge controls:
- Yes. A vehicle challenge control group and a vehicle rechallenge control group of five male and five females each received the vehicle for the induction dosing period.
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde
Results and discussion
- Positive control results:
- The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Not measured/tested
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% (induction)
1% (challenge) - No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% (induction)
2.5% (challenge) - No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance would not meet the classification requirements for skin sensitization.
- Executive summary:
The dermal sensitization potential of EC 701 -204 -9 was evaluated in male and female Hartley-derived albino guinea pigs when administered by multiple topical applications. Ten male and ten female guinea pigs were topically treated with 75% test article concentration, once per week, for three consecutive weeks. In addition, each group contained a vehicle challenge control group and a vehicle rechallenge control group of five male and five females each that received the vehicle for the induction dosing period. Following a two-week rest period, a challenge was performed whereby the twenty test, ten vehicle challenge control and ten previously untreated naive challenge control guinea pigs were topically treated with 25% test article concentration. Challenge responses in the test animals were compared with those of the vehicle challenge control and the naive challenge control animals. Following a seven day rest period, a rechallenge was performed at 25% in which the twenty test, ten vehicle rechallenge control and ten previously untreated naive rechallenge control guinea pigs were topically treated with the appropriate test article concentration. Rechallenge responses in the test animals were compared to those of the vehicle rechallenge control and the naive rechallenge control animals. In addition, the rechallenge response of each animal was compared to its challenge response. Dermal responses of 1 or greater were noted in 4 of 20 animals following primary challenge with 25% test article. Dermal responses of 1 or greater were noted in 1 of 20 animals following rechallenge with 25% test article. Dermal responses of 1 or greater were not noted in any animal following rechallenge with 10% test article. Dermal responses of 1 or greater were not noted in any of the vehical controls. The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
Since the dermal responses observed following primary challenge at 25% could not be replicated at subsequent rechallenges, the conclusion of the study is that EC 701 -204 -9 did not elicit a skin sensitization response under the conditions of this study.
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