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EC number: 274-635-9 | CAS number: 70514-12-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-11-18 to 1980-12-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was classified as reliable without restrictions because it was conducted according to OECD guideline 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study performed in 1980 before other test guidelines available.
Test material
- Reference substance name:
- Distillates (petroleum), solvent-dewaxed light paraffinic
- EC Number:
- 265-159-2
- EC Name:
- Distillates (petroleum), solvent-dewaxed light paraffinic
- Cas Number:
- 64742-56-9
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Institute (Wayne, New Jersey)
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Individually in polycarbonate cages
- Diet (e.g. ad libitum): Purina Guinea Pig Chow® ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: 1980-11-04 To: 1980-12-27
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Dose Titration - 0.1, 0.5, 1.0, and 2.0 mL
Induction and Challenge - 1.0 mL
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Dose Titration - 0.1, 0.5, 1.0, and 2.0 mL
Induction and Challenge - 1.0 mL
- No. of animals per dose:
- 10 male guinea pigs/dose
- Details on study design:
- RANGE FINDING TESTS: A range-finding study was conducted by administering API 78-9 at doses of 0.1, 0.5, 1.0, and 2.0 mL to 3 guinea pigs with the first two doses administered to one animal at separate sites. The test material was applied to 1 square inch guaze pads backed by plastic occlusive wrap held in place by elastic tape. The test material was applied for 6 hours and then removed. Thereafter, the test sites were scored for edema and erythema based on the method of Draize and the highest non-irritating dose was used in the subsequent main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Test groups: single test group with 10 male guinea pigs
- Control group:not utilized
- Site: Either side of thorax, half-way down from the shoulders to the hips
- Frequency of applications: 3/week for 3 weeks
- Duration: 3 weeks
- Concentrations: 1.0 mL
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: ~ Day 35
- Exposure period: 6 hours
- Test groups: single test group with 10 male guinea pigs
- Control group: not utilized
- Site: Right side of thorax, half-way down from the should
- Concentrations: 1.0 mL
- Evaluation (hr after challenge): 24 hours post challenge
- Challenge controls:
- Not utilized
- Positive control substance(s):
- yes
- Remarks:
- 0.5 mL of a 0.05% w/v solution of chlorodinitrobenzene in ethanol
Results and discussion
- Positive control results:
- At challenge, 9 of 10 animals in the positive control group exhbited very slight erythema (1) while 1 animals exhibited well-defined erythema (2) 24 hours post-exposure. There was no edema observed at challenge in any animal in the positive control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0 mL. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 mL. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: None reported.
Any other information on results incl. tables
Table 1. Mean Erythema and Edema Scores for Treatments and Challenge |
|||||
Parameter |
Mean Score |
Difference (Mean) |
T-Value |
Degrees of Freedom |
Two Tail Probability |
API 78-8 |
|||||
Erythema |
|
|
|
|
|
Sensitizing |
0.18 |
0.18 |
3.86 |
9 |
0.004+ |
Challenge |
0.00 |
||||
Edema |
|
|
|
|
|
Sensitizing |
0.00 |
0.00 |
No T value (SD = 0) |
9 |
|
Challenge |
0.00 |
||||
Positive Control |
|||||
Erythema |
|
|
|
|
|
Sensitizing |
0.47 |
-0.63 |
-7.24 |
9 |
0.000* |
Challenge |
1.10 |
||||
Edema |
|
|
|
|
|
Sensitizing |
0.05 |
0.05 |
3.00 |
9 |
0.015+ |
Challenge |
0.00 |
*Statistically significant difference (p<0.05)
+Statistically significant difference, but challenge mean is less than the sensitizing mean.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test, Solvent dewaxed light paraffinic oil is considered non-sensitizing.
- Executive summary:
In a guinea pig skin sensitization test, 10 male Hartley guinea pigs were induced and subsequently challenged by topical administration of Solvent dewaxed light paraffinic oil.
Initially 3 guinea pigs were tested with 0.1, 0.5, 1.0, and 2.0 mL of Solvent dewaxed light paraffinic oil in a range-finding study. Based on the results of the range-finding study, the 1.0 mL dose was selected for the subsequent induction and challenge phases of the experiment. 24 hours prior to exposure, the guinea pigs were shaved with a clipper blade on either side of the thorax from the shoulders down till the hips. 1.0 mL of the test material was applied to 1 square inch guaze sponges backed by an occlusive plastic wrap that was then kept in contact with the skin for 6 hours with elastic tape. 24 hours after patch removal, the animals were scored for irritation based on the method of Draize. The test material was subsequently applied (following the same procedure) three times per week for three consecutive weeks following which the animals were held for a period of two weeks and then challenged with 1.0 mL of Solvent dewaxed light paraffinic oil. the procedure followed for the challenge phase was the same as that employed during induction. A positive control group of 10 male guinea pigs was dosed with 0.5 mL of 0.05% w/v solution of chlorodintrobenzene in ethanol and data generated was analyzed using the student's t test.
A significant difference was observed in the mean erythema scores between the induction (sensitizing) and challenge phases. However, the challenge mean scores were zero for both parameters observed (erythema and edema) indicating that Solvent dewaxed light paraffinic oil is not a sensitizer. In the positive control group, challenge erythema scores were significantly higher than those observed in the induction phase indicating that chlorodintrobenzene is a dermal sensitizer.
Under the conditions of this study, Solvent dewaxed light paraffinic oil is not considered to be a dermal sensitzer.
This study was classified as reliable without restrictions because it was conducted according to OECD guideline 406.
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