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EC number: 242-016-2 | CAS number: 18127-01-0
- 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 test substance was assessed for acute oral toxicity in rats using a single dose administered by oral gavage. The LD50 was calculated to be 2.66 mL/kg bw with 95% confidence limits of 2.43 and 2.9 mL/kg bw.
The test substance was assessed for acute dermal toxicity in New Zealand white rabbits. There were no treatment-related deaths therefore the LD50 was > 5000 mg/kg.
Supporting information was available on the analogue substance Florhydral. An acute dermal toxicity study was performed on rats using a fixed dose procedure. The LD50 was > 5000 mg/kg for Florhydral. A further acute dermal study was performed on rabbits also using a fixed dose procedure. In this study on the analogue substance, Florhydral, the LD50 was > 5000 mg/kg.
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was administered to male and female rats by gavage in single doses of 2.4, 2.9, 3.2 or 4.2 mL per kg bw. After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14 day period, after wich autopsies were carried out on survivors and the LD 50 was calculated.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, Netherlands.
- Age at study initiation: Young adult, age not specified.
- Weight at study initiation: Males 200 to 260 g, females from 100 to 134 g.
- Fasting period before study: Overnight
- Diet (e.g. ad libitum): Stock diet available ad libitum
- Water (e.g. ad libitum): Ad libitum
- Housing: In groups of 5 in stainless-steel cages with grid-bottom and front.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1 °C
- Air changes (per hr): Well ventilated, but air changes not specified. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2.4, 2.9, 3.5 or 4.2 mL/kg bw
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: Observed for signs of intoxication. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2.66 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 2.43 - 2.91
- Mortality:
- Deaths occurred between 7 h and 3 days after dosing. Then the survivors recovered gradually and looked quite healthy at the end of the observation period.
- Clinical signs:
- other: Within a few hours after treatment the rats showed sedation and signs of ataxia. Later, signs of emaciation, encrustations around eyes and nostrils and coma were frequently observed.
- Gross pathology:
- Macroscopic examination of the survivors did not reveal any treatment-related gross alterations.
- Conclusions:
- The test substance was assessed for acute oral toxicity in rats using a single dose administered by oral gavage. The LD50 was calculated to be 2.66 mL/kg bw with 95% confidence limits of 2.43 and 2.9 mL/kg bw.
Reference
Doses applied and mortality figures:
Dose (mL/kg) |
Mortality |
||
Number |
Percent |
||
Males |
Females |
||
2.4 |
2/5 |
1/5 |
30 |
2.9 |
3/5 |
4/5 |
70 |
3.5 |
4/5 |
5/5 |
90 |
4.2 |
5/5 |
5/5 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 550 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- Testing by the inhalation route in accordance with column 2 of Annex VIII of 1907/2006/EC, is considered to be inappropriate as exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance (0.2 Pa at 25°C) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. As an objective of regulation EC No. 1907/2006 is to reduce, replace or refine animal testing, based on this information, it can be reasonably expected that inhalation exposure is not expected and as such, it is not warranted to test the hypothesis in animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- 3rd July 1980 to 1st August 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was applied once to the clipped skin of New Zealand white rabbits at 5 g/kg over approximately 10 % of the body surface. Abrasions were made in half of the rabbits and extended the length of the exposure site, scratching only the strarum corneum, but did not reach the derma or produce bleeding. The area was covered with an occlusive dressing for 24 h after which the wrapping was removed and the exposed area was wiped, but not washed, to remove excess material. Dermal reactions were scored at 1, 7 and 14 days according to Draize. The rabbtis were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. All animals were examined for gross pathology at termiantion.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Nicholas Helf
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: 2/ cage in suspended wire mesh cages
- Diet (e.g. ad libitum): Purina rabbit chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 1 week - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10 %
- Type of wrap if used: Gaize patches secured with adhesive tape and the trunks were wrapped with impervious material.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was not done but the test area was wiped to remove excess test material.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg. The dose was based on the sample weight as calculated from the specific gravity.
- Constant volume or concentration used: No, volume ranged from 12.2 to 13.8 cc.
- For solids, paste formed: Not applicable, test material is a liquid - Duration of exposure:
- Single exposure; the test material was not removed.
- Doses:
- 5 g/kg
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal reactions were scored at 1, 7 and 14 days. The rabbits were scored daily for 14 days for signs of toxicity, pharmacological effects and mortality. Bodyweights were recorded pre-test and in the survivors at 14 days.
- Necropsy of survivors performed: Yes, all animals were examined for gross pathology. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- test mat.
- Mortality:
- There was one death at Day 4.
- Clinical signs:
- other: In the rabbit that died, pre-death toxic signs were diarrhoea, tachypnea, prostration, flaccid muscle tone and spasm. Toxic sings in survivors included lethargy and diarrhoea. Slight to moderate erythema was noted on Days 1 and 7 and was absent or slight
- Gross pathology:
- Necropsy findings of survivors were normal. The spontaneous death had lung abnormalities.
- Conclusions:
- The test substance was assessed for acute dermal toxicity in New Zealand white rabbits. There were no treatment-related deaths therefore the LD50 was > 5.0 g/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Acute oral toxicity
The test substance was assessed for acute oral toxicity in rats using a single dose administered by oral gavage. The LD50 was calculated to be 2.66 mL/kg bw with 95% confidence limits of 2.43 and 2.9 mL/kg bw. (density = 0.959 g/ml) = 2550 mg/kg bw which is above the level for classification according to CLP (2000 mg/kg bw).
Acute inhalation toxicity
No study was avaliable.
Acute dermal toxicity
The test substance was assessed for acute dermal toxicity in New Zealand white rabbits. There were no treatment-related deaths therefore the LD50 was > 5000 mg/kg.
Supporting information was available on the analogue substance Florhydral. An acute dermal toxicity study was performed on rats using a fixed dose procedure. The LD50 was > 5000 mg/kg for Florhydral. A further acute dermal study was performed on rabbits also using a fixed dose procedure. In this study on the analogue substance, Florhydral, the LD50 was > 5000 mg/kg.
To support toxicological endpoints as part of the REACH registration of Bourgeonal (Target substance) it is proposed to read across to Florhydral (Source substance). The use of read-across works within the spirit of REACH, and the stated aim of the legislation to reduce animal testing where possible. The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD QSAR toolbox. From the profile, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified.
Justification for selection of acute toxicity – oral endpoint
The sudy was performed on the target substance using standard
methodology. 2.66 ml/kg bw (density = 0.959 g/ml) = 2550 mg/kg bw
Justification for selection of acute toxicity – dermal endpoint
The sudy was performed on the target substance using standard
methodology.
Justification for classification or non-classification
Based on the oral LD50 values of 2550 mg/kg bodyweight and dermal LD50 values of > 5000 mg/kg bodyweight, there is no need to classify Bourgeonal for acute to toxicity in accordance with the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
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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