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EC number: 608-251-3 | CAS number: 287930-77-2
- 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 key studies are an acute oral toxicity study in rats and an acute dermal toxicity in rats both with an LD50 of >2000 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:
- April 29 to May 19, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterize
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- July 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Remarks:
- OECD Principles of Good Laboratory Practice, Statutory Instrument No. 654, 1997, ISBN 0-11-064105-1
- Test type:
- fixed dose procedure
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK., Margate, Kent, England
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 175 - 232g
- Fasting period before study: overnight
- Housing: The dose range-finding animal was housed singly in a cage with dimensions 42 x 27 x 20 cm, and the main study animals were housed 5 per cage per sex with dimensions 59 x 38.5 x 20 cm
- Diet: Rat and Mouse No. 1 Maintenance Diet, supplied by Special Diets Services Limited, 1 Stepfield, Witham, Essex, CMS 3AD was available ad libitum throughout the study except for a period of food deprivation overnight prior to dosing until as soon as practicable after dosing.
- Water: Domestic mains quality water was available ad libitum throughout the study
- Acclimation period: 5 days before commencement of study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): During the study, mean environmental maximum and minimum temperatures were 22°c and 19°C
- Mean Humidity (%): 50 %
- Air changes (per hr): 15 minimum
- Photoperiod (hrs dark / hrs light):12/24 - Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- The available toxicity data suggested that an initial dose level of 2000 mg/kg would be suitable. The main study dose level was selected based on the results from the dose range-finding study.
The test material was administered orally in a single dose by means of a gavage at a constant dose volume of 10 ml/kg.
The dose was calculated based on the weight of the animal on the day of dosing. - Doses:
- dose level: 2000 mg/kg
- No. of animals per sex per dose:
- A preliminary dose range-finding, using one female, at 2000 mg/kg indicated that this dose level would be suitable for the main study. 5 females and 5 males were used for this main study.
- Control animals:
- no
- Details on study design:
- The dose was calculated based on the weight of the animal on the day of dosing.
Formulations were administered within approximately 1 hour of preparation and were magnetically stirred during dosing.
All the animals were checked for viability early in the morning and again as late as possible on each day until sacrifice on Day 8 (dose range-finding) or Day 15 (main study). - Statistics:
- No formal statistical analysis was conducted
- Preliminary study:
- The available toxicity data suggested that an initial dose level of 2000 mg/kg would be suitable. The main study dose level was selected based on the results from the dose range-finding study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no premature decedents during the study
- Clinical signs:
- other: Clinical signs were noted from approximately 5 to 6 hours after dosing and on Day 2. These signs were limited to wet, stained perigenital area and soft jelly like faeces
- Gross pathology:
- There were no abnormalities detected at necropsy.
Dose Level
(mg/kg) Animal/Sex Necropsy Finding Day of Death
2000 6-10male No abnormalities detected 15
11-15 female No abnormalities detected 15 - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study following a single oral administration of L-744,341 to Sprague-Dawley rats, no mortality and no toxicity occurred at 2000 mg/kg
- Executive summary:
There were no premature decedents or major clinical signs noted during the obsevation period.
Body weight performance was considered to be satisfactory, and there were no abnormalities detected at necropsy.
Under the conditions of the study following a single oral administration of L-744,341 to Sprague-Dawley rats, no mortality and no toxicity occurred at 2000 mg/kg
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
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:
- 2015-01-07 to 2015-01-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Based on OECD test guideline and GLP compliant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, B3: "Acute Toxicity (Dermal)"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000), including the most recent revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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:
- Species Rat, Wistar strain, Crl:WI (Han) (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC). Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals: 5 males and 5 females (females were nulliparous and non-pregnant).
Age and body weight: Young adult animals (approx. 10 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Conditions
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Individually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm).
Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study. - Type of coverage:
- open
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1% Aqueous carboxymethyl Not indicated cellulose
- Details on dermal exposure:
- The formulation was applied on an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore). - Duration of exposure:
- 24 hours, after which dressings were removed and the skin cleaned of residual test substance using tap water.
- Doses:
- 2000 mg/kg (10 mL/kg) body weight.
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were subjected to daily observations and weekly determination of body weight. Mortality/viability was observed twice daily. Animals were weighed on days 1 (pre-administration), 8 and 15. Clinical signs were observed at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Terminal sacrifice was performed on day 15 - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Lethargy, flat posture, hunched posture, piloerection, chromodacryorrhoea (snout) and/or ptosis were noted for the animals on Day 1. White staining and/or scales were seen in the treated skin-area of the animals between Days 2 and 11.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 value of Montelukast Backbone Diol in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, Montelukast Backbone Diol does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity oral: .
There were no premature decedents or major clinical signs noted during the observation period., body weight performance was considered to be satisfactory, and there were no abnormalities detected at necropsy.Un
under the conditions of the study following a single oral administration of the substance to Sprague-Dawley rats, no mortality and no toxicity occurred at 2000 mg/kg. Acute dermal toxicity: No mortality occurred. Clinical signs: Lethargy, flat posture, hunched posture, piloerection, chromodacryorrhoea (snout) and/or ptosis were noted for the animals on Day 1. White staining and/or scales were seen in the treated skin-area of the animals between Days 2 and 11. The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity. No abnormalities were found at macroscopic post mortem examination of the animals.Justification for classification or non-classification
The key studies are an acute oral toxicity study and an acute dermal toxicity in rats with an LD50 of >2000 mg/kg.
Based on these results, Montelukast Backbone Diol does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all 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.
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