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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
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.
The acute dermal toxicity of Genagen PA was investigated according to the Guideline OECD 403. Rats were treated semi occusively at 2000 mg/kg bw for 24h. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw:
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 October 2016 to 17 December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Acute Oral Toxicity - Acute Toxic Class Method" adopted on 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- 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
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)
- Solubility of the test substance in the vehicle: Corn oil (200 mg/mL)
FORM AS APPLIED IN THE TEST: Liquid - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- 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: 167.21 g to 177.61 g
- Fasting period before study: overnight (16 to 18 hours) prior to dosing
- Housing:Three animals were housed in standard polypropylene cage (Size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet (Sterilizable) manufactured by Envigo
- 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: 28 October 2016; End: 09 November 2016
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0°C to 22.5°C
- Humidity (%): 50% to 65%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 28 October 2016; To: 24 November 2016 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Step-I & Step-I Confirmation: 30 mg/mL;
Step-II & Step-II Confirmation: 200 mg/mL;
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle:As per the in-house solubility/suspendibility test, test item formed a suspension in corn oil.
- batch no: C-167
- Purity: Pure
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION: A small quantity of vehicle was added to test item and mixed well and thereafter the formulation was transferred into measuring cylinder. Again, a small quantity of vehicle was added to the mortar and rinsed and transferred into the measuring cylinder. Finally the volume was made up to required quantity with vehicle to get a desired volume
CLASS METHOD
- Rationale for the selection of the starting dose: As no information on LD50 of Genagen PA/ N,N-Dimethylnonanamide in rats was available, a starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight - Doses:
- Step-I and Step I confirmation: 300 mg/kg body weight;
Step-II and Step II confirmation: 2000 mg/kg body weight - No. of animals per sex per dose:
- 3 females per step per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily once for clinical signs and weekly body weights
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality at both tested doses (300 and 2000 mg/kg body weight)
- Clinical signs:
- other: No clinical signs of toxicity observed at both tested doses (300 and 2000 mg/kg body weight)
- Gross pathology:
- No gross pathological changes were observed in any of the animals at 300 mg/kg body weight in Step I and Step I confirmation and 2000 mg/kg body weight in Step II and Step II confirmation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One valid Guideline study.
Acute toxicity: via dermal route
Link to relevant study records
- 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 - 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
- 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 - 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 - 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
- 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. - 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 - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One valid Guideline study.
Additional information
Justification for classification or non-classification
The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw. No classification is justified for the endpoint acute oral toxicity.
The acute dermal toxicity of Genagen PA was investigated according to the Guideline OECD 403. Rats were treated semi occusively at 2000 mg/kg bw for 24h. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw. No classification is justified for the endpoint acute oral toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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