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Diss Factsheets
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EC number: 612-975-5 | CAS number: 6225-08-7
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 April 2017 to 19 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Genagen PA/ N,N-Dimethylnonanamide
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 402 (Section 4: Health Effects) “Acute Dermal Toxicity” adopted on 24 February 1987
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N-dimethylnonanamide
- EC Number:
- 612-975-5
- Cas Number:
- 6225-08-7
- Molecular formula:
- C11H23NO
- IUPAC Name:
- N,N-dimethylnonanamide
- Details on test material:
- - Name of test material (as cited in study report): N,N-Dimethylnonanamide
- Synonyme: Genagen PA
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: 112-2016-11 D
- Expiration date of the batch: May 2018
STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)
FORM AS APPLIED IN THE TEST
The test item applied topically (dermal exposure) as such
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 Weeks
- Weight at study initiation: 217.93 g to 231.98 g (males); 201.61 g to 207.91 g (females)
- Housing: Individual in a standard polypropylene cage (size: L 430 x B 285 x H 150 mm)
- Diet (ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet - Pellet
- Water (e.g. ad libitum):Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier
- Acclimation period: Start: 13 April 2017; End: 17 April 2017
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4°C to 23.4°C
- Humidity (%): 44% to 64%
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 13 April 2017; To: 02 May 2017
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorso-lateral area of the trunk
- % coverage: 10% of the total body surface
- Type of wrap if used: Crepe bandage
REMOVAL OF TEST SUBSTANCE
- Washing: Washed with distilled water and dried with absorbent cotton
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount applied:2000 mg/kg body weight
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs daily once and weekly once weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- Clinical Signs of Toxicity and Mortality: The animals did not reveal any clinical signs of toxicity and mortality during the observation period and did not reveal any skin reactions.
Body Weight and Percent Change in Body Weight with Respect to Day 1: The body weight and percent change in body weight with respect to Day 1 of all the animals were increased during the observation period.
Pathology: No treatment related gross pathological findings were observed in any of the animals sacrificed at the end of the experimental period.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortalities were noted
- Clinical signs:
- other: No Clinical signs were noted
- Gross pathology:
- No gross pathological findings were observed in any of the animals
- Other findings:
- - Organ weights: Not applicable
- Histopathology: Not applicable
- Potential target organs: Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity of Genagen PA was investigated according to the Guideline OECD 402. Rats were treated semioccusively at dose of 2000 mg/kg bw for 24h. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of Genagen PA was investigated according to the Guideline OECD 402. Rats were treated semioccusively at dose of 2000 mg/kg bw for 24h. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.
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