Registration Dossier
Registration Dossier
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EC number: 265-191-7 | CAS number: 64742-88-7 A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-01-7 to 1985-01-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it is an acceptable and well-documented study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Odourless kerosine
- IUPAC Name:
- Odourless kerosine
- Details on test material:
- IUCLID4 Test substance: other TS: Odourless kerosine
- Name of test material (as cited in study report):
- Substance type: Kerosine
- Physical state: Liquid
- Expiration date of the lot/batch: January 1985
- Storage condition of test material: In the dark, at ambient temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 3 to 6 months
- Weight at study initiation: 3.4 kg to 4.9 kg
- Housing: Individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19 °C
- Humidity (%): monitored
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL applied undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 3 male, 3 female
- Details on study design:
- TEST SITE
- Area of exposure: 2 cm x 2 cm
- % coverage: no data
- Type of wrap if used: gauze, elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scale of 0 to 4 for both erythema and edema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The only skin reaction was barely perceptible erythema in all but one rabbit at 24 hours, but this cleared by 48 hours post-exposure.
Any other information on results incl. tables
The
only skin reaction was a barely perceptible erythema which persisted in
all rabbits at 24hours post dosing but had cleared by 48 hours.
Group mean scores (24, 48 and 72 hrs) were:
Erythema: 0.17
Edema: 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The group mean 24, 48, and 72 hour scores for erythema and edema were 0.17 and 0.0 respectively. Under the conditions of this study, the test material was classified as not irritating according to EU criteria.
- Executive summary:
In a skin irritation study, three male and three female rabbits were treated with 0.5 mL of undiluted test material. The test material was applied to a single shorn area of skin and covered by a layer of gauze. The wrapping was removed after four hours of exposure and the site was scored for erythema and edema at 30 minutes after patch removal, and at 24, 48, and 72 hours and 7 and 14 days after application. The group mean 24, 48, and 72 hour scores for erythema and edema were 0.17 and 0.0 respectively. Under the conditions of this study, the test material was classified as not irritating according to EU criteria.
This study received a Klimisch score of 1 and is classified as reliable without restrictions because it is an acceptable and well-documented study report.
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