Registration Dossier
Registration Dossier
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EC number: 481-740-5 | CAS number: 848301-67-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study on supporting substance (with limited range, C8-C12) conducted in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear
- IUPAC Name:
- Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear
- Details on test material:
- - Substance type: Organic
- Physical state: Liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Information not available
- Isomers composition: Information not available
- Purity test date: December 06, 1995
- Expiration date of the lot/batch: Information not available
- Stability under test conditions: Stable under normal temperature and pressure
- Storage condition of test material: Under cool conditions (approximately 4°C)
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young rabbits, approximately 3 months old
- Weight at study initiation: Individual body weights were recorded for each animal at test begin (2.29 to 2.62 kg) and at least weekly thereafter.
- Housing: Animals were individually housed in suspended stainless steel cages mounted in mobile batteries.
- Diet (e.g. ad libitum): Free access to standard pelleted diet.
- Water (e.g. ad libitum): Free access (ad libitum)
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15 to 23°C)
- Humidity (%): 55% R.H. (range 40% to 70% R.H.
- Air changes (per hr): Al least 10 complete air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h : 12 h
IN-LIFE DATES:
From: 5 March 1996 to 20 March 1996
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): pure test substance
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
- Concentration (if solution): no vehicle used
- Lot/batch no. (if required): no vehicle used
- Purity: no vehicle used - Duration of treatment / exposure:
- 4 h
- Observation period:
- 16 d
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure:
Test area 6x6 cm, single dose was applied to skin (3x2 cm)
- % coverage:
Not applicable
- Type of wrap if used:
Treated skin was covered by an unmedicated gauze patch (3x2 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Dressings were removed after exposure and treatment sites gently washed with warm water and dried with paper tissues.
- Time after start of exposure:
After 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0.89
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: max duration of effect: 10 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: max duration of effect: 7 days
- Other effects:
- Exfoliation was evident at all test sites from Day 7 until termination on Day 16. The exfoliation observed at termination of the study probably reflected a recovery process from a drying effect of the test material.
Any other information on results incl. tables
| Animal number and Sex | Erythema | Oedema | ||
| Test | Control | Test | Control | |
| 32TD944, Female | 1.0 | 0.0 | 0.0 | 0.0 |
| 32TD945, Female | 0.3 | 0.0 | 1.0 | 0.0 |
| 32TD946, Female | 1.0 | 0.0 | 0.0 | 0.0 |
| 32TD947, Female | 1.0 | 0.0 | 0.0 | 0.0 |
| 32TD948, Female | 1.0 | 0.0 | 0.0 | 0.0 |
| 32TD949, Female | 1.0 | 0.0 | 0.0 | 0.0 |
| Overall Mean Score | 0.9 | 0.0 | 0.2 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear', an analogue to 'Distillates (Fischer-Tropsch), C8-26-branched and linear' was considered to be slightly irritating to rabbit skin.
According to Annex VI of Council Directive 67/548/EEC 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' is unclassified with regards to skin irritation.
Finally, the related substance 'Distillates (Fischer-Tropsch), C8-26-branched and linear' should also not be classified. Although the test material is not classified the following additional classification makes sense: R66 (EUH066) Repeated exposure may cause skin dryness or cracking. - Executive summary:
The potential of the test item to cause skin irritation on New Zealand White rabbits was investigated according to OECD guideline 404 and US-EPA OTS 798.4470 (Skin irritation). A volume of 0.5 mL test item was applied to six female rabbits.
Under the conditions of this test, the test item was considered to be slightly irritating to the skin. However, the test material did not meet the criteria for classifcation as a skin irritant according to EU CLP Regulation.
Finally, the analogue 'Distillates (Fischer-Tropsch), full range, C8 -26-branched and linear' should also be slightly irritating to the skin and should also not be classified. Although the test material is not classified, the following additional classification makes sense: R66 (EUH066) Repeated exposure may cause skin dryness or cracking.
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