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EC number: 423-640-6 | CAS number: 179911-08-1 AGARBOIS
- 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:
- September 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of study performance, the LLNA method was not adopted.
Test material
- Reference substance name:
- N-ethyl-N-(3-methylphenyl)propionamide
- EC Number:
- 423-640-6
- EC Name:
- N-ethyl-N-(3-methylphenyl)propionamide
- Cas Number:
- 179911-08-1
- Molecular formula:
- C12H17NO
- IUPAC Name:
- N-ethyl-N-(3-methylphenyl)propanamide
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd
- Weight at study initiation:
- Housing: 308 and 394g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3°C
- Humidity (%): 50% +/- 20%.
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- DOBS Saline
- Concentration / amount:
- Induction: injection 0.3% in DOBS saline and 100% dermally
- Day(s)/duration:
- Day 1 and 7 / 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 20 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 (ten males and ten females)
- Details on study design:
- lntradermal injection
The hair was clipped from a 2cm x 4cm area of skin in the dorsal shoulder area and three pairs of intradermal injections were made within the clipped area as follows:
1. Two 0.1ml injections of 1:1 FCA and saline.
2. Two 0.1ml injections of 0.3% test item in DOBS saline.
3. Two 0.1ml injections of 1:1 0.6% test item in DOBS saline and FCA to give a resultant concentration of 0.3%
The injection sites were scored 24 hours after treatment
Occluded patch application
Seven days after the injections the same 2cm x 4cm area was clipped and shaved. A 2cm x 4cm filter paper patch, attached by double-sided adhesive tape to 4 4cm x 6cm piece of thin polythene, was saturated with 100.0% test item (as supplied) and placed over the shaved site. The patch was held in place for 48 hours by adhesive plaster wrapped around the trunk behind the forelimbs. The occluded patch site was scored 24 hours after removal of the bandage.
Challenge
Thirteen days after the application of the induction patch the guinea pigs were challenged on the clipped and shaved flank by occluded patch. For each animal, two 8mm diameter filter paper patches in two 11mm aluminium patch test cups were applied to the shaved flank, one saturated with 50.0% test item in Alembicol D and the other saturated with the solvent. The patches were held in place for 24 hours by adhesive plaster wound around the trunk.
The treatment sites were examined for evidence of sensitization 24 and 48 hours after removal of the patches - Challenge controls:
- At the same time as the test animals were selected, ten (five male and five female) guinea pigs were selected as treated controls (Group B) for challenge. The control guinea pigs were selected so that their body weights were similar to those of the test guinea pigs at challenge. The guinea pigs received two intradermal injections of 1:1 mixture of FCA and saline, two 0.1ml injections of DOBS saline and two 0.1ml injections of a 1:1 mixture of FCA and DOBS saline in exactly the same way as the test animals. This was followed seven days later by a 48 hour occluded "blank" patch over the injection sites. The animals were assessed after both induction procedures as described for the test animals.
The control animals were challenged with the test material at the same time and in the same manner as the test animals. - Positive control substance(s):
- yes
- Remarks:
- Hexyl Cinnamic Aldehyde
Results and discussion
- Positive control results:
- 90% positive
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test item was classed as a non-sensitiser and does not require labelling according to Part Il(B) of Annex VI of Directive 67/548/EEC relating to the classification of dangerous substances and preparations, "(Official Journal of the European Communities, No L383 A131 B.6. - 29.12.1992)".
- Executive summary:
Magnusson and Kligman guinea pig maximisation test. This method is similar to that described in the Official Journal of the EuropeanCommunities No. L383 Al31 B.6. Acute Toxicity (Skin Sensitization), 29.12.1992 and OECD Guideline 406 for Testing of Chemicals(1993).
Sensitization was induced in guinea pigs by intradermal injections of both test substance and Freund's Complete Adjuvant. Seven days later the induction process was supplemented by application of the test substance to the shoulder injection sites under occlusion for 48 hours.
Thirteen days later the guinea pigs were challenged by a 24 hour occluded patch of the test substance, the treatment sites were then examined for evidence of sensitization 24 and 48 hours after removal of the challenge patch.
Induction (intradermalinjection):
1) A 1:1 mix of Freund's Complete Adjuvant (FCA) with 0.9% (w/v) physiological saline (saline).
2) 0.3% (w/v) test item in 0.01% dodecylbenzene sulphonate in 0.9% physiologic alsaline (DOBS saline)
3) 0.6% (w/v) Agarbois in DOBS saline mixed 1:1with FCA to give a final concentration of 0.3% (w/v) of test item
Induction (occluded patch application): 100% (as supplied) test item
Challenge (occluded patch application): 50.0% (w/v) Agarbois in Alembicol D.
Results:
There was no evidence of any sensitization reactionsinany of the twenty test guinea pigs challenged with 50.0% test item.
Conclusion:
Under the conditions of this study, test item was classed as a non-sensitiser and does not require labelling according to Part Il(B) of Annex VI of Directive 67/548/EEC relating to the classification of dangerous substances and preparations. "(Official Journal of the European Communities, No L383 A131 B.6. - 29.12.1992)".
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