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EC number: 272-745-1 | CAS number: 68910-55-4
- 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
Organolignite was neither a dermal or ocular irritant based on the lack of irritation observed in OECD 404 and 405 studies.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-06-27 to 2013-07-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Greenfield, Indiana
- Age at study initiation: Approximately 8 ½ months
- Weight at study initiation: 3.83 to 3.92 kg
- Housing: Individually housed in suspended, stainless steel, slatted floor cages
- Diet (e.g., ad libitum): Lab Diet® Certified Rabbit Diet #5322 limited upon arrival and increased in 25 g increments during the acclimation period until feeding was 125 g per day
- Water (e.g., ad libitum): Tap water available ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~ 16 to 22°C (61 to 72°F)
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Test material mixed with water to form a paste; the final ratio of test article to deionized water used for each application was 1:2. - Duration of treatment / exposure:
- 4 hr
- Observation period:
- 1, 24, 48, and 72 hours following the 4 hour dose period (patch removal)
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Test article was placed on gauze patches (approximately 6 cm2) and then applied to the skin on the right side of the dorsal trunk
- Type of wrap if used: Gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes with tepid tap water and a WypAll®
- Time after start of exposure: After the 4 hr exposure
SCORING SYSTEM: Draize scale
Erythema and Eschar Formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema Formation
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well-defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No erythema was observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No edema was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No dermal irritation was observed at any point in the study, with the mean erythema and edema score both being 0 over 24 to 72 hr. In this study, organolignite is not a dermal irritant based on the lack of irritation observed throughout the study period.
- Executive summary:
In a primary dermal irritation study, three male New Zealand White Hra:(NZW)SPF albino rabbits were dermally exposed to 0.5 g of organolignite for 4 hours under semi-occlusive conditions. Organolignite was moistened with deionized water to form a paste and final ratio of test article to deionized water used for each application was 1:2. Animals then were observed for 3 days. Irritation was scored by the Draize method.
No dermal irritation was observed at any point in the study, with the mean erythema and oedema score both being 0 over 24 to 72 hr. Based on the study results, organolignite is not a dermal irritant since no irritation was observed throughout the study period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-07-09 to 2013-07-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- In the opinion of the Study Director, there is no impact on the quality or integrity of the study in connection to this deviation.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Greenfield, Indiana
- Age at study initiation: Approximately 5 months
- Weight at study initiation: 2.83 to 3.52 kg
- Housing: Individually housed in suspended, stainless steel, slatted floor cages
- Diet (e.g., ad libitum): Lab Diet® Certified Rabbit Diet #5322 limited upon arrival and increased in 25 g increments during the acclimation period until feeding was 125 g per day
- Water (e.g., ad libitum): Tap water available ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~ 16 to 22°C (61 to 72°F)
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g of solid
- Duration of treatment / exposure:
- 24 hr
- Observation period (in vivo):
- 1, 24, 48, 72 hr following dose administration
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: immediately following the 24 hr scoring
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No ulceration or opacity was observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No ocular irritation of the iris was observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No ocular irritation was observed during the 24 to 72 hour observation periods of the study. Reddening (Grade 1) of the conjunctivae and conjunctivae sac, as well as ocular discharge, were noted during the 1 hour observation period, but were resolved by 24 hours post dose. In this study, organolignite is not an ocular irritant based on the lack of irritation observed during the 24 to 72 hour observation periods.
- Executive summary:
In a primary eye irritation study, 0.1 g of organolignite (solid) was instilled into the conjunctival sac of the right eye of New Zealand White Hra: (NZW) SPF albino rabbits (3 males) for 24 hours. Eyes were immediately washed following the 24 hour scoring and sodium fluorescein examination. Animals then were then observed for 3 days, and ocular irritation evaluations were conducted at approximately 1, 24, 48, and 72 hours following dose administration. Irritation was scored by the method of Draize.
No ocular irritation was observed during the 24 to 72 hour observation periods of the study. Reddening (Grade 1) of the conjunctivae and conjunctivae sac, as well as ocular discharge, were noted during the 1 hour observation period, but were resolved by 24 hours post dose. Based on the study results, organolignite is not an ocular irritant since no irritation was observed during the 24 to 72 hour observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Organolignite was neither a dermal or ocular irritant based on the lack of irritation observed in OECD 404 and 405 studies. Study details are provided below.
In a primary dermal irritation study, three male New Zealand White Hra: (NZW) SPF albino rabbits were dermally exposed to 0.5 g of organolignite for 4 hours under semi-occlusive conditions. Organolignite was moistened with deionized water to form a paste and final ratio of test article to deionized water used for each application was 1:2. Animals then were observed for 3 days. Irritation was scored by the Draize method.
No dermal irritation was observed at any point in the study, with the mean erythema and oedema score both being 0 over 24 to 72 hr. Based on the study results, organolignite is not a dermal irritant since no irritation was observed throughout the study period.
In a primary eye irritation study, 0.1 g of organolignite (solid) was instilled into the conjunctival sac of the right eye of New Zealand White Hra: (NZW) SPF albino rabbits (3 males) for 24 hours. Eyes were immediately washed following the 24 hour scoring and sodium fluorescein examination. Animals then were then observed for 3 days, and ocular irritation evaluations were conducted at approximately 1, 24, 48, and 72 hours following dose administration. Irritation was scored by the method of Draize.
No ocular irritation was observed during the 24 to 72 hour observation periods of the study. Reddening (Grade 1) of the conjunctivae and conjunctivae sac, as well as ocular discharge, were noted during the 1 hour observation period, but were resolved by 24 hours post dose. Based on the study results, organolignite is not an ocular irritant since no irritation was observed during the 24 to 72 hour observation period.
Justification for classification or non-classification
Organolignite does not meet the criteria for classification and labelling as a skin irritant under CLP EU Regulation 1272/2008 based on evaluation of the overall mean erythema and oedema scores from a key skin irritation study.
Organolignite does not meet the criteria for classification and labelling as an eye irritant as defined by CLP EU Regulation 1272/2008 based on evaluation of overall mean eye irritation scores from a key eye irritation study.
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