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EC number: 938-793-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- 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
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- 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:
- 1979-09-21 to 1979-10-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- not specified
Test material
- Reference substance name:
- #2 home heating oil (50% catalytically-cracked)
- IUPAC Name:
- #2 home heating oil (50% catalytically-cracked)
- Details on test material:
- - Name of test material (as cited in study report): API #78-4, #2 home heating oil (50% cat)
- Substance type: petroleum distillation product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 50% virgina gas oil and 50% cracked gas oil
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not provided by sponsor
- Storage condition of test material: 30 mL was removed from Elars' test material storage room and placed in an amber vial in the study room for the duration of the test.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Institute
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: housed in stainless steel
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 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: not reported
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- 0.5 mL of undiluted test material
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- 0.5 mL of undiluted test material
- No. of animals per dose:
- 10 animals per dose
- Details on study design:
- RANGE FINDING TESTS: not reported
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 exposures
- Exposure period: 6 hours
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: back of guinea pigs
- Frequency of applications: 3 times per week
- Duration: 3 weeks
- Concentrations: 0.5 mL of undiluted test material
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after last induction exposure
- Exposure period: 6 hours
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: backs of guinea pigs
- Concentrations: 0.5 mL of undiluted test material
- Evaluation (hr after challenge): 24 hours
- Positive control substance(s):
- yes
- Remarks:
- chlorodinitrobenzene in ethanol
Results and discussion
- Positive control results:
- No statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 1.1 average erythema score and 0.5 average oedema score
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 1.1 average erythema score and 0.5 average oedema score.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% w/v dilution of chlorodinitrobenzene
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- mean erythema = 1.9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% w/v dilution of chlorodinitrobenzene. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: mean erythema = 1.9.
Any other information on results incl. tables
Phase |
Average Dermal Irritation Score |
|||
API #78-4 |
Positive Control |
|||
Erythema |
Oedema |
Erythema |
Oedema |
|
Induction Phase Average |
1.0 |
0.3 |
1.3 |
0.3 |
Challenge Phase Average |
1.1 |
0.5 |
1.9 |
0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a skin sensitisation study, there were no statistically significant differences between the mean of the averages of the ten sensitising treatments and the mean of the challenge treatment for wither erythema or oedema in the test or control group. Based on these results, the test material is considered non-sensitising.
- Executive summary:
In a skin sensitisation study, ten young adult male albino rabbits were exposed to 0.5 mL of undiluted test material in the treatment group and ten
ten young adult male albino rabbits were exposed to 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol in the positive control group. Both groups were shaved in an area on their backs approximately 3" x 3" in size. On the day of application, test material or positive control was placed on a gauze patch which was put on the shaved exposure site, covered with plastic wrap and wrapped with elastic bandaging. Bandaging and wrapping was removed 6 hours after application. The same procedure was replicated 3 times a week for 3 weeks (10 treatments in total). Two weeks after the last induction dose, a single challenge dose was administered following the same methods as used during the induction period, in both the treatment and positive control groups. Scoring of erythema and oedema was made at 24 hours after each application.
Results indicated no statistically significant differences between the mean of the averages of the ten sensitising treatments and the mean of the challenge treatment for wither erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.
This study received a Klimisch score of 2 and is classified as reliable with restriction because it was conducted similar to guideline study OECD 406.
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