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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 28 days
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Stoddard solvent
- EC Number:
- 232-489-3
- EC Name:
- Stoddard solvent
- Cas Number:
- 8052-41-3
- Molecular formula:
- C10H22
- IUPAC Name:
- stoddard solvent
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- 10 of each gender per test group and control group
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Stoddard Solvent CAS# 8052-41-3) was evaluated for toxicity in New Zealand White (NZW) rabbits when administered to the skin 3 times per week over the course of 4 weeks. Stoddard Solvent was applied to the clipped, intact skin of groups of male and female rabbits (5/sex/group) at dose levels of 0, 200, 1000, or 2000 mg/kg. Immediately following application, the sites were covered with surgical gauze, wrapped with polyethylene material and taped for 6 hours. At the end of 6 hours, the occlusive wrapping was removed and any excess material gently wiped off. One female from the high dose group (group 4) was sacrificed in a moribund condition on Day 14, after showing decreased feed intake on Days 12 through 14 and marked weight loss on Day 14. Microscopic examination revealed mucoid enteritis as a probable cause of morbidity and was considered incidental to treatment. Weight gains of males from groups 2 and 3 (200 and 1000 mg/kg) were comparable to those of control males.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 weeks.
- Frequency of treatment:
- Once per day, 3 times per week (12 total applications)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- groups of male and female rabbits (5/sex/group)
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The shaved intact skin (15 × 20 cm) of groups of 10 New Zealand White rabbits was exposed to doses of 200, 1000, and 2000 mg/kg of white spirit (Stoddard solvent).
Exposure was carried out usining occlusion bandage for a duration of 6 h and was given 3 times weekly for 4 weeks.
Examinations
- Observations and examinations performed and frequency:
- The animals were observed for signs of overt toxicity, dermal irritation, effects on body weight and consumption, haematology and serum chemistry parameters.
- Sacrifice and pathology:
- Complete necropsies were performed on all animals.
- Other examinations:
- Selected organs were weighed and a microscopic examination was conducted on selected tissues from all animals at the scheduled necropsy.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 2000 mg/kg, female rabbits developed liver lesions characterized as white streaks or foci with granular surface
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- Dermal irritation was scored as being severe in group 4 males and females and group 3 males and moderate in group 3 females and group 2 animals (males and females).
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At the highest dose level, there was a significant reduction in weight gain in both sexes, whereas only the female body weight gain was reduced at 1000 mg/kg.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Mean food consumption (evaluated as g/animal/day) was slightly but consistently decreased in the high dose group (males) during the first two thirds of the study period, and this was attributed to the test article.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- No information provided
- Ophthalmological findings:
- not specified
- Description (incidence and severity):
- No test related ophthalmic lesions were present at the week 12 opthalmologic examinations.
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in haematological parameters noted at 2000 mg/kg were judged not to be treatment- related.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the serum chemistry parameters albumin means were decreased and globulin means were increased (resulting in decreased A/G ratios). Again this was attributed to the acute dermal inflammation that was observed.
- Urinalysis findings:
- not specified
- Description (incidence and severity):
- No information provided
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Group 4 females (2000 mg/kg) showed a negative weight gain and significantly lower terminal body weights relative to controls.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No significant changes reported (except for the dermal application sites for all the dose groups)
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No significant changes reported (except for the dermal application sites for all the dose groups)
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- other: on the basis of a l reduced absolute mean liver weight and increased relative mean kidney weight (left kidney).
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Microscopic examination revealed mucoid enteritis as a probable cause of morbidity and was considered incidental to treatment. Weight gains of males from groups 2 and 3 (200 and 1000 mg/kg) were comparable to those of control males.
Males from group 4 (2000 mg/kg) showed significantly lower weight gains and, subsequently, significantly lower body weights than controls at terminal sacrifice. Females from group 2 had body weight gains comparable to controls, while group 3 females had significantly lower weight gains and terminal body weights than control females.
Group 4 females (2000 mg/kg) showed a negative weight gain and significantly lower terminal body weights relative to controls.
Dermal irritation was scored as being severe in group 4 males and females and group 3 males and moderate in group 3 females and group 2 animals (males and females).
Group 4 (2000 mg/kg) males had significantly reduced absolute mean liver weight and increased relative mean kidney weight (left kidney). Females from groups 4 and 3 showed a significant increase in relative cerebrum weight over controls.
The majority of lesions noted upon gross examination at necropsy were seen in the skin and were associated with dermal irritation. Females in the high dose group were seen to have white streaks or foci on the livers of 2 animals, while a third exhibited a granular surface on the liver. Other gross lesions observed in treated animals were few, uniformly small, and occurred with the same frequency as in controls. Microscopic examination of treated animals revealed lesions in the skin at the application site including thickening and down-growth of the epidermis, hyperkeratosis, and dermal fibrosis. The incidence and severity of the observed lesions were significantly greater in high dose animals compared to controls and animals in the lower dose groups. There were a small number of lesions noted from other tissues (heart, trachea, pancreas, testes, and spleen) but these were considered unrelated to treatment.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for this study was determined to be 2000 mg/kg.
- Executive summary:
The shaved intact skin (15 × 20 cm) of groups of 10 New Zealand White rabbits was exposed to doses of 200, 1000, and 2000 mg/kg of white spirit (Stoddard solvent). Exposure was carried out using occlusion bandage for a duration of 6 h and was given 3 times weekly for 4 weeks. At the highest dose level, there was a significant reduction in weight gain in both sexes, whereas only the female body weight gain was reduced at 1000 mg/kg. Changes in haematological parameters noted at 2000 mg/kg were judged not to be treatment-related. At 2000 mg/kg, female rabbits developed liver lesions characterized as white streaks or foci with granular surface
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