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EC number: 701-177-3 | 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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation in vivo (similar OECD 406, GPMT): not sensitising
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:
- key study
- Study period:
- 09 Feb - 19 Mar 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- lack of test material and study details, no reliability check
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 270-400 g
- Housing: animals were housed individually in Macrolon III cages.
- Diet: standard guinea-pig pellets - NAFAG No. 830 (Gossau SG), ad libitum and supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 14/14 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: 20% ethanol / 80% saline (intradermal), vaseline PhH VI (epidermal)
- Concentration / amount:
- 5% and 30%
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 3%
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture adjuvant (Bacto Adjuvant complete Freund, Difco) and saline
Injection 2: test substance in saline
Injection 3: a mixture of the test substance with the adjuvant saline mixture
Epicutaneous: test substance in vaseline
- Control group: no information
- Site: neck region
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 30%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: vehicle only
- Site: flank
- Concentrations: 3%
- Evaluation (hr after challenge): 48 h
OTHER: The application sites were chemically depilated 3 h before examination. - Positive control substance(s):
- no
- Positive control results:
- No tests with a positive control group had been performed. The study had been performed in 1981!
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 5 and 30%; challenge: 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 5 and 30%; challenge: 3%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 3 animals with very slight erythema and 2 animals with well defined erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Clinical observations: 3 animals with very slight erythema and 2 animals with well defined erythema.
- Group:
- positive control
- Remarks on result:
- other: no data in study report
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising properties of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC No. 701-177-3) were tested in a guinea pig maximisation test (GPMT) similar to OECD guideline 406 (Ciba Geigy, 1981c). In the study, Pirbright white guinea pigs (20/group) were induced with a single intradermal injection of the test substance at 5% (in 20% ethanol, 80% saline) using the adjuvant complete Freund and an epicutaneous application of the test substance at 30% (Vaseline PhH VI) on the injection site. The negative control group was included in the study but no information about treatment was given. Epicutaneous challenge exposure was conducted 20 days after the first induction for 24 h under occlusive conditions. 3% of the test substance was applied on the flank. Evaluation of skin reactions was carried out 24 h after challenge. No positive control substance was included in the study. No skin reactions were observed in any animal in the negative control group. In the treatment group, three animals with very slight erythema and two animals with well defined erythema were observed (corresponding to 25% positive results). Thus, the available data on skin sensitisation do not provide evidence for sensitising properties of the test substance under the conditions of the study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation with N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC No. 701-177-3) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.
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