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EC number: 232-489-3 | CAS number: 8052-41-3 A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
- 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
White spirit (Stoddard solvent containing 14.5% aromatics) was found not to be sensitizing in a Buehler test. A 75% (by volume) solution of white spirit (Stoddard solvent) in a vehicle of paraffin oil used for the three sensitizing doses was found to induce mild to moderate irritation. A 25% (by volume) solution was used as a challenge dose.
Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.
Results: No evidence of sensitization
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler Test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.
- Specific details on test material used for the study:
- Stoddard solvent (8052-41-3) Aromatics 14.5 (%), Boiling Point Range 160-199 °C
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Shizuoka
- Age at study initiation: 5 weeks
- Weight at study initiation: 313-337 g
- Housing: animals were housed in aluminium cages with stainless steel wire mesh floors (350 mm x 400 mm x 200 mm, Natsume Seisakusyo Co., Tokyo); 5 animals/cage.
- Diet (e.g. ad libitum): standard pelleted diet for guinea-pigs (RC-4; Oriental Yeast Co.) ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):23±2
- Humidity (%): 50±10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12hrs light
IN-LIFE DATES: 19-Jun-1997 to 04-Sep-1997 - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 75% (v/v) in paraffin oil for induction
- Day(s)/duration:
- three weeks
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% (v/v) solution in paraffin oil challenge dose
- No. of animals per dose:
- 10 test, 5 control
- Details on study design:
- Ten male Hartley guinea pigs were treated once a week for three weeks with 0.4 ml of 75% test substance in paraffin oil.
Two weeks after final application, they were challenged with 0.4 ml of 25% test substance in paraffin oil.
Scores were taken at 24 and 48 hours.
A vehicle control group was tested using paraffin oil only; a naïve control group was tested in the challenge phase only; a positive control group was tested using dilute solutions of 2,4-dinitrochlorobenzene. - Challenge controls:
- A 25% (by volume) solution was used as a challenge dose
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
- Positive control results:
- Evidence presented over a relevant time period that the strain of guinea pig did respond to known sensitisers.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test
- Remarks on result:
- other: see Remark
- Remarks:
- There were reportedly no significant differences in general condition and body weight gain between test and control groups over the course of the test.
- Interpretation of results:
- other: not sensitising
- Conclusions:
- Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.
Results: No evidence of sensitization - Executive summary:
Stoddard solvent showed no evidence of being a skin sensitizer when tested using the Buehler test in a reliable study conducted in accordance with OECD Guidelines 406. The study was GLP compliant.
Results: No evidence of sensitization
Reference
White spirit (Stoddard solvent containing 14.5% aromatics) was found not to be sensitizing in a Buehler test. A 75% (by volume) solution of white spirit (Stoddard solvent) in a vehicle of paraffin oil used for the three sensitizing doses was found to induce mild to moderate irritation. A 25% (by volume) solution was used as a challenge dose.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Exposure to mice of 350 mg/m3 (56 ppm vapour) or 1200 mg/m3 (vapour plus aerosol) of dearomatized Stoddard solvent (140° Flash Aliphatic Solvent)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Stoddard solvent (140° Flash Aliphatic Solvent)
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- six male Swiss-Webster mice
- Route of induction exposure:
- inhalation
- Route of challenge exposure:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- 350 mg/m, 1200 mg/m3 , 3200 mg/m3 , 4400 mg/m3, 10 000 mg/m3
- No. of animals per dose:
- six male Swiss-Webster mice
- Details on study design:
- Exposure to Swiss-Webster mice (vapour plus aerosol) at concentration of 350 mg/m, 1200 mg/m3 , 3200 mg/m3 , 4400 mg/m3, 10 000 mg/m3
- Results:
- There was used respiratory depression in mice as an index of irritative response in the upper respiratory tract. Three of six male Swiss-Webster mice developed a decline in respiratory rate (below 50% of the normal rate) during 1 min of exposure to 10 000 mg/m3 (1700 ppm vapour and aerosols) of white spirit (Stoddard solvent; 15% aromatics). A similar decrease in respiratory rate did not occur at 4400 mg/m3 (770 ppm).
Exposure to mice of either 350 mg/m3 (56 ppm vapour) or 1200 mg/m3 (vapour plus aerosol) of dearomatized white spirit (140° Flash Aliphatic Solvent) did not induce respiratory tract irritation or change in respiratory rate - Interpretation of results:
- other: not respiratory irritation
- Conclusions:
- There was used respiratory depression in mice as an index of irritative response in the upper respiratory tract. Three of six male Swiss-Webster mice developed a decline in respiratory rate (below 50% of the normal rate) during 1 min of exposure to 10 000 mg/m3 (1700 ppm vapour and aerosols) of white spirit (Stoddard solvent; 15% aromatics). A similar decrease in respiratory rate did not occur at 4400 mg/m3 (770 ppm).
Exposure to mice of either 350 mg/m3 (56 ppm vapour) or 1200 mg/m3 (vapour plus aerosol) of dearomatized white spirit (140° Flash Aliphatic Solvent) did not induce respiratory tract irritation or change in respiratory rate
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Exposure to mice of either 350 mg/m3(56 ppm vapour) or 1200 mg/m3(vapour plus aerosol) of dearomatized white spirit (140° Flash Aliphatic Solvent) did not induce respiratory tract irritation or change in respiratory rate
Justification for classification or non-classification
Based on the hazard assessment ofStoddard solventin section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Respiratory Sensitisation Xn R42 May cause sensitization by inhalation Respiratory Irritation Xi R37 irritating to respiratory system |
CLP |
Respiratory Sensitisation H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled Respiratory Irritation H335 STOT SE 3 May cause respiratory irritation |
It is concluded that the substance Stoddard solvent does not meet the criteria to be classified for human health hazards for Inhalation-local effect:respiratory irritation/corrosion and/or respiratory sensitisation.
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