Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 224-623-4 | CAS number: 4430-31-3
- 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
Acute oral (OECDTG401): no adverse effect observed
Acute dermal (OECDTG402): no adverse effect observed
Acute inhalation (Route to route extrapolation): no adverse effect predicted
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:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no details on test material (purity not indicated), no details on test animals and environmental conditions, observation period unknown (only until day 5 included in report).
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
No details.
ENVIRONMENTAL CONDITIONS
No details. - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No details.
- Doses:
- 1730, 2470, 3510 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 1730 mg/kg bw: total 20 (no sex specified)
2470, 3510 and 5000 mg/kg bw: 10 (no sex specified) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 600 - 5 900
- Mortality:
- See "any other information results"
- Clinical signs:
- other: 1730 mg/kg bw: Lethargy, chromorhynorrhea, piloerection, ptosis and diarrhea. 2470 mg/kg bw: Lethargy and flaccid muscle tone. 3510 mg/kg bw: Lethargy, chromorhynorrhea and piloerection. 5000 mg/kg bw: Lethargy, chromorhynorrhea, piloerection, ataxia, red
- Interpretation of results:
- other: Not acute harmful.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- An LD50 of 3900 mg/kg bw was obtained in the acute oral toxicity study with rats. According to GHS the substance needs to be classified for acute oral toxicity category 5 and labelled with H103: May be harmful if swallowed.
- Executive summary:
In an acute oral toxicity study 4 groups of 10 rats were orally exposed to 1730, 2470, 3510 and 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and pharmacological effects for a period of 5 days. Deaths occurred on day 0, 1, 2, 4 and 5. Lethargy was seen at all levels, other clinical signs were chromorhynorrhea, piloerection, ataxia, red exudate, ptosis, diarrhea, falccid muscle tone and anogenital.
Based on the results, an LD50 of 3900 mg/kg bw was obtained in the acute oral toxicity study with rats.
Reference
Deaths per day after exposure to Bicyclononalactone
Dose mg/kg |
Deaths/day |
total |
1730 |
3/0, 1/1, 1/2, 1/5 |
6/20 |
2470 |
1/0, 2/1 |
3/10 |
3510 |
2/0, 1/1, 1/4 |
4/10 |
5000 |
3/0, 3/1 |
6/10 |
Necropsy observations after exposure to Bicyclononalactone
No. of rats | ||||
Doses mg/kg bw | 1730 | 2470 | 3510 | 5000 |
Normal | 8 | 2 | 1 | |
Cannabalized | 2 | |||
Exudate, nose/mouth, red | 2 | 3 | 2 | |
Exudate, nose/mouth, yellow | 1 | 1 | 3 | |
Exudate, anogenital, brown | 1 | |||
Exudate, anogenital, yellow | 2 | |||
Exudate, nose/mouth, clear | 1 | 2 | ||
Intestines, areas red | ||||
Intestines, areas yellow | 4 | 4 | 1 | 9 |
Intestines, bloated | 1 | |||
Stomach, areas red | 1 | 1 | ||
Liver dark | 8 | 2 | 4 | |
Liver mottled | 1 | 6 | 2 | |
Lungs dark | 1 | 3 | 2 | 4 |
Lungs areas dark | 1 | 3 | 2 | |
Consolidation of left lung * | 1 | |||
Kidney dark | 9 | 3 | 2 | 4 |
Kidney mottled | 1 | 4 | ||
Spleen dark | 2 | |||
Spleen large | 2 | 4 | ||
Spleen, tip darker than normal | 1 | |||
Bladder, contained blood | 1 | 2 |
* Hardened texture to lung tissue w/ yellowish nodules troughout.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The reliability score is based on the study is similar to current OECD guideline but not GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no details on test material (purity not indicated), no details on test animals and environmental conditions, observation period unknown (only until day 5 included in report), no details on dermal exposure.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
No details.
ENVIRONMENTAL CONDITIONS
No details. - Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No details specified.
- Duration of exposure:
- No details.
- Doses:
- 1250, 2500 and 5000 mg/kg bw
- No. of animals per sex per dose:
- Total of 4 (sex not specified).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 200 - 5 700
- Mortality:
- See "any other information results"
- Clinical signs:
- other: At 2500 mg/kg bw lethargy was observed in one animal on day 1. All other animals showed no abnormalities at any dose level.
- Gross pathology:
- See "any other information results"
- Other findings:
- Irritation: See "any other information results"
- Interpretation of results:
- other: Not acute harmful.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- An LD50 of 3500 mg/kg bw was obtained in the acute dermal toxicity study with rabbits. According to GHS the substance needs to be classified for acute dermal toxicity category 5 and labelled with H313: May be harmful in contact with skin.
- Executive summary:
In an acute dermal toxicity study 3 groups of 4 rabbits were dermally exposed to 1250, 2500 and 5000 mg/kg bw of Bicyclononalactone. The rabbits were observed for signs of toxicity and pharmacological effects for a period of 5 days. Deaths occurred on day 1 and 2. At 2500 mg/kg bw lethargy was observed in one animal on day 1 and one animal died. At 5000 mg/kg bw 3/4 animals died by day 2. Slight to moderate redness and slight edema was observed in all animals. Based on the results, an LD50 of 3500 mg/kg bw was obtained in the acute dermal toxicity study with rabbits.
Reference
Deaths per day after exposure to Bicyclononalactone
Dose mg/kg bw |
Deaths/day |
total |
1250 |
0 |
0/4 |
2500 |
1/1 |
1/4 |
5000 |
2/1, 1/2 |
3/4 |
Skin irritation after exposure to Bicyclononalactone
Dose mg/kg bw | 1250 | 2500 | 5000 |
Redness: | |||
Slight | 1/3 * | 1/2 ** | |
Moderate | 4/4 | 2/3 | 1/2 |
Edema: | |||
Slight | 4/4 | 3/3 | 2/2 |
* 1 animal dead prior to reading
** 2 animals dead prior to reading
Necropsy observations after exposure to Bicyclononalactone
No. of rats |
||||
Doses mg/kg bw |
1250 |
2500 |
5000 |
|
Normal |
|
2 |
1 |
|
Exudate, nose/mouth, yellow |
|
|
1 |
|
Exudate, anogenital, brown |
|
1 |
2 |
|
Intestines, areas red | 1 | 3 | ||
Intestines, areas yellow | 1 | |||
Intestines, bloated | 3 | 1 | 3 | |
Stomach, areas red | 1 | |||
Liver dark | 3 | 1 | ||
Liver mottled | 1 | 3 | ||
Lungs dark | 2 | |||
Lungs areas dark | 1 | 1 | ||
Kidney dark | 1 | 1 | ||
Kidney mottled | 2 | |||
Skin edema | 2 | |||
Skin redness | 2 | |||
Intestines, contained green fluid | 1 | |||
Liver white nodules | 1 | |||
Gall bladder large | 1 | |||
Kidney pale | 1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute dermal toxicity result is of sufficient quality and adequate for this dossier.
Additional information
Acute oral toxicity: In an acute oral toxicity study 4 groups of 10 rats were orally exposed to 1730, 2470, 3510 and 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and pharmacological effects for a period of 5 days. Deaths occurred on day 0, 1, 2, 4 and 5. Lethargy was seen at all levels, other clinical signs were chromorhynorrhea, piloerection, ataxia, red exudate, ptosis, diarrhea, falccid muscle tone and anogenital.
Based on the results, an LD50 of 3900 mg/kg bw was obtained in the acute oral toxicity study with rats.
Acute inhalation: Acute inhalation is predicted based on the acute oral toxicity in accordance with the ECHA CLP guidance document (2015, 3.1.3.3.4: 1 mg/kg bw = 0.0052 mg/l (5.2 mg/m3). The acute inhalation is predicted to be 10140 mg/m3 (using 100% inhalation and 50% oral absorption). The calculated saturated vapour pressure is 13.3 mg/m3 (MW in mg*VP in Pa/ 8.3 (gas constant*293oK). This means that the acute inhalation concentration cannot be reached and therefore no acute inhalation toxicity is anticipated.
Acute dermal toxicity: In an acute
dermal toxicity study 3 groups of 4 rabbits were dermally exposed to
1250, 2500 and 5000 mg/kg bw of Bicyclononalactone. The rabbits were
observed for signs of toxicity and pharmacological effects for a period
of 5 days. Deaths occurred on day 1 and 2. At 2500 mg/kg bw lethargy was
observed in one animal on day 1 and one animal died. At 5000 mg/kg bw
3/4 animals died by day 2. Slight to moderate redness and slight edema
was observed in all animals. Based on the results, an LD50 of 3500 mg/kg
bw was obtained in the acute dermal toxicity study with rabbits.
Justification for classification or non-classification
The substance does not have to be classified for acute toxicity by the oral, inhalation and dermal route according to Regulation (EC) No. 1272/2008 and its amendments .
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.