Registration Dossier
Registration Dossier
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EC number: 265-052-0 | CAS number: 64741-51-1 A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985-08-20 to 1986-02-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because the study closely followed OECD 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- 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:
- The first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.
Test material
- Reference substance name:
- 64741-50-0
- Cas Number:
- 64741-50-0
- IUPAC Name:
- 64741-50-0
- Reference substance name:
- Unrefined light paraffinic distillate
- IUPAC Name:
- Unrefined light paraffinic distillate
- Test material form:
- other: oily liquid
- Details on test material:
- - Name of test material (as cited in study report): 84-01 Light Paraffinic Distillate
- Test substance: Unrefined light paraffinic oil
- Physical state: Yellow liquid
- CAS number: 64741-50-0
- Molecular weight (if other than submission substance): 296
- CAS number: 64741-50-0
- Viscosity, cSt: 2.67 at 100°C
- API Gravity: 31.5
- Flash Point: (°F) 372
- Sulfur, Wt %: 0.2
- Nitrogen ppm: 256
- Distillation ASTM D 86 equivalent (°F) range: 601-803 (10-95%)
- Initial Boiling Point (°F): 579
- Composition of test material, Wt. %:
Olefins: 39.7
Naphthenes 21.7
- PONA 37% by MS
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland Inc., Denver, Pennsylvania
- Age at study initiation: 5 to 6 weeks of age
- Weight at study initiation: Between 435 and 595 grams
- Housing: Individual cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24 degrees Celsius
- Humidity (%): 37% to 62% relative humidity
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Paraffin oil
- Concentration / amount:
- A 25% volume/volume mixture of the in paraffin oil was used for the induction applications.
1% volume/volume mixture was used for the challenge dose.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Paraffin oil
- Concentration / amount:
- A 25% volume/volume mixture of the in paraffin oil was used for the induction applications.
1% volume/volume mixture was used for the challenge dose.
- No. of animals per dose:
- 10 animals were exposed per dose application.
- Details on study design:
- RANGE FINDING TESTS:
6 guinea pigs received two concentrations of undiluted test concentrations of 25%, 50% and 75% volume/volume in paraffin oil. Additional testing at 10% and 1% volume/volume were needed due to the irritation seen at the 25% volume/volume test.
Results from range finding test:
1% - no dermal irritation
10% - slight dermal irritation and no response
25% - slight dermal irritation
50% - well defined dermal irritation
undiluted test material applications - well defined dermal irritation
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One application per week for three weeks, for a total of three applications
- Exposure period: 6 hours
- Test groups: Six groups consisting of 10 guinea pigs each group. Dose range group tested 6 animals.
- Control group: The positive control group tested 20 guinea pigs
- Site: Back of each animal. Hair was removed.
- Frequency of applications: One application per week for three weeks
- Duration: Three weeks
- Concentrations: 25%
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: One
- Exposure period: 21 hours
- Test groups:
- Control group: Vehicle control group dosed with 0.4 mL of undiluted paraffin oil. Positive and naive control group: 0.4 mL of a 0.1% w/v suspension of 2,4- dinitrochlorobenzene in acetone.
- Site: Previously untreated test sites were used for the challenge application
- Concentrations: 0.4 mL of 1% v/v mixture of test material in paraffin oil.
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene 0.3% w/c in 80% aqueous ethanol.
Study design: in vivo (LLNA)
- Positive control substance(s):
- other: 2, 4-dinitrochlorobenzene
Results and discussion
- Positive control results:
- Slight to severe irritation was exhibited by all twenty animals. The reactions of all 20 animals equaled or exceeded the highest reaction observed in the naive positive control animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: sensitisation phase
- Group:
- test chemical
- Dose level:
- 0.4 mL at 25%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: other: sensitisation phase. Group: test group. Dose level: 0.4 mL at 25%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: slight erythema .
- Reading:
- other: challenge phase
- Group:
- test chemical
- Dose level:
- 0.4 mL at 1%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: other: challenge phase. Group: test group. Dose level: 0.4 mL at 1%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: slight erythema .
- Reading:
- other: sensitising phase
- Group:
- negative control
- Dose level:
- undiluted Paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of erythema or oedema
- Remarks on result:
- other: Reading: other: sensitising phase. Group: negative control. Dose level: undiluted Paraffin oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of erythema or oedema.
- Reading:
- other: challenge phase
- Group:
- negative control
- Dose level:
- undiluted Paraffin oil
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- slight erythema, no oedema
- Remarks on result:
- other: Reading: other: challenge phase. Group: negative control. Dose level: undiluted Paraffin oil. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: slight erythema, no oedema.
- Reading:
- other: sensitisation phase
- Group:
- positive control
- Dose level:
- 0.4 mL at 0.3%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- slight to severe irritation
- Remarks on result:
- other: Reading: other: sensitisation phase. Group: positive control. Dose level: 0.4 mL at 0.3%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to severe irritation.
- Reading:
- other: challenge phase
- Group:
- positive control
- Dose level:
- 0.4 mL at 0.1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- slight to severe irritation
- Remarks on result:
- other: Reading: other: challenge phase. Group: positive control. Dose level: 0.4 mL at 0.1%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to severe irritation.
Any other information on results incl. tables
The
criteria used to evaluate the responses are described in the report as
follows:
Determination of sensitization was based upon reactions to the challenge
dose. Grades of 1 or greater in the test animals indicate evidence of
sensitization, provided grades of less than 1 are seen in the naive
controls. If grades of 1 or greater are noted in the naive control
animals, then the reactions of test animals that exceed the most severe
naive control reaction are considered sensitization reactions.
Using these criteria, none of the test animals became sensitized
following treatment with API 84-01. In contrast, all the positive
control animals were sensitized by their treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 84-01 was not considered to be a skin sensitizer in guinea pigs when tested by the closed patch technique.
- Executive summary:
In a dermal sensitization study using 84 -01 in paraffin oil, 10 young Hartley guinea pigs were tested using the method of Buehler.
Slight erythema reaction was exhibited by six animals but did not exceed the highest reaction of the naive control animals. The other four animals tested did not exhibit a reaction. In this study, 84 -01 is not considered to be a dermal sensitizer.
This study received a Klimisch score of 1 and is classified as reliable without restriction because the study closely followed OECD 406.
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