Registration Dossier
Registration Dossier
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EC number: 300-227-8 | CAS number: 93924-33-5 A distillate obtained from the redistillation of a complex combination of hydrocarbons obtained by the distillation of the effluents from a severe catalytic hydrotreatment of paraffins. It boils in the range of approximately 190°C to 330°C (374°F to 594°F).
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-10-28 to 1982-08-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it is an acceptable and a well-documented study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Primary dermal irritation score includes scores from abraded skin. OECD TG 404 does not recommend testing on abraded skin. Also the test involved 24hr occluded exposure
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrodesulfurised middle distillate (CAS# 64742-80-9)
- IUPAC Name:
- Hydrodesulfurised middle distillate (CAS# 64742-80-9)
- Details on test material:
- - Name of test material (as cited in study report): API 81-09 (CAS# 64742-80-9)
- Physical state: Clear liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately 14 weeks of age
- Weight at study initiation: Average body weights reported prior to treatment was 2716 g.
- Housing: The animals were maintained in individual cages with screened floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: At least 14 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 22 degrees Celsius
- Humidity (%):38% to 55% relative humidity
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The animals were dosed with 0.5 mL per prepared area.
No vehicle was used. - Duration of treatment / exposure:
- 24 hours per exposure
- Observation period:
- 24, 72 and 96 hours, 7 and 14 days.
- Number of animals:
- 6 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: The back of each animal was exposed to test material
- % coverage: not reported
- Type of wrap if used: gauze patches, secured with paper tape and saran wrap were use to maintain the test material in contact with the skin. Collars were used to retrain the animals.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test areas were not washed but were wiped.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize technique
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hour scores
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hour scores
- Score:
- 2.25
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean erythema score for intact skin is 1.9 and the mean oedema score is 2.25.
- Executive summary:
In a primary dermal irritation study, six, young adult New Zealand White rabbits, were dermally exposed to 0.5 mL of undiluted hydrodesulfurised middle distillate under occlusion (24 hour contact time) applied to one abraded area and one intact area of skin.
Dermal irritation was scored according to the method of Draize at 24, 72 and 96 hours, and 7 and 14 days after test material application. One animal died on day 11 (considered unrelated to treatment).
The mean erythema score for intact skin is 1.9 and the mean oedema score is 2.25.
This study received a Klimisch score of 2 and is classified as reliable with restriction because it is an acceptable and well documented study report.
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