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EC number: - | 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
'Cell Free Harpin Extract of Harpinαβ produced by fermentation' is not considered to be acutely harmful by the oral route.
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:
- 4 April - 12 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- - Test material: EBC 351 (1% Harpin αß)
- Lot No. of test material: DP021112
- Expiration date of the lot: 20 Feb 04
- Appearance: Pale yellow granular solid
- Storage: Refrigerated at 4°C
The test substance EBC 351 is a product formulation containing 11% w/w of the reference substance, 'Cell Free Harpin Extract of Harpinαβ produced by fermentation', and various other non-toxic substances including maltodextrin (listed in Annex IV of Regulation No/ 1907/2006). Therefore, any toxicity seen in the toxicology studies would most likely be caused by the presence of the reference substance rather than the other product co-formulants. Furthermore, ECB 351 contains a higher percentage of Harpin αß and fermentation solids then the reference substance (ca. 11% versus ca. 5%) and therefore the study results would actually over-estimate the toxicity expected if the reference substance itself had been tested. Therefore, results obtained with EBC 351 can be used in support of the reference substance 'Cell Free Harpin Extract of Harpinαβ produced by fermentation'. - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Texas Animal Specialties, Humble, Texas
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 9 weeks old
- Weight at study initiation: 172 - 193 g
- Fasting period before study: 16 hours before dosing
- Housing: Suspended, wire bottom, stainless steel cage; 1 animal per cage
- Diet: PMI Feeds Inc. Formulab #5008 available ad libitum
- Water: Municipal water supply available ad libitum from automatic water system
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30 - 70%
- Air changes (per hr): 10 - 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/ dark cycle
IN-LIFE DATES: From: 06 April 2003 To: 23 April 2003 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40% w/v
MAXIMUM DOSE VOLUME APPLIED: 12.6 mL/kg dose was administered - Doses:
- 5050 mg/kg
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations for mortality and clinical/ behavioural signs of toxicity: at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days
- Frequency of weighing: Individual body weights were recorded just prior to dosing and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 050 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There was no mortality during the study.
- Clinical signs:
- other: All animals appeared normal for the duration of the study.
- Gross pathology:
- The gross necropsy conducted at termination of the study revealed no observable abnormalities.
- Other findings:
- - Actual temperature: 21 - 26°C
- Actual relative humidity: 30 - 79%
[Deviations of high temperature/ humidity did not affect the study outcome] - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of the test substance, EBC 351 (1% Harpin ab), is estimated to be greater than 5050 mg/kg in females. Based on this result, the acute oral toxicity of 'Cell Free Harpin Extract of Harpinαβ produced by fermentation' is also expected to be acutely non-toxic and to be above the limit of classification.
Reference
Table 1: Body weights, time of death and gross necropsy (Dose level 5050 mg/kg, 12.6 mL/kg)
Animal No. |
Date of dosing |
Body weights (g) |
Time of death* |
Gross necropsy findings |
||
Day 0 |
Day 7 |
Final |
||||
71-F |
7 Apr 03 |
193 |
235 |
253 |
Day 14 |
No observable abnormalities |
72-F |
9 Apr 03 |
180 |
217 |
250 |
Day 14 |
No observable abnormalities |
73-F |
9 Apr 03 |
172 |
207 |
218 |
Day 14 |
No observable abnormalities |
* Day of dosing is Day 0; Day 14 is terminal sacrifice
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
Oral: The oral LD50 for rats was >2000 mg/kg bw in a study performed in accordance with EPA OPPTS 870.1100. Therefore, the substance does not require classification according to the criteria described in Regulation (EC) No. 1272/2008.
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