Registration Dossier
Registration Dossier
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Reaction product of Crude sludge and Calcium oxide. Crude sludge is the mixture of by-products of petroleum hydrocarbons refining (especially Total petroleum hydrocarbons, Polycyclic aromatic hydrocarbons, acid-refined heavy petroleum distillates). The Crude sludge is neutralised by calcium oxide in the ratio 80:20. The maturing process proceeds under ambient conditions and takes for at least 3 days. Subsequently, the reaction product is processed mechanically.
EC number: 930-592-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31.5. - 9.6.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out in accordance with internationally valid GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction product of Crude sludge and Calcium oxide. Crude sludge is the mixture of by-products of petroleum hydrocarbons refining (especially Total petroleum hydrocarbons, Polycyclic aromatic hydrocarbons, acid-refined heavy petroleum distillates). The Crude sludge is neutralised by calcium oxide in the ratio 80:20. The maturing process proceeds under ambient conditions and takes for at least 3 days. Subsequently, the reaction product is processed mechanically.
- EC Number:
- 930-592-4
- Molecular formula:
- Not available
- IUPAC Name:
- Reaction product of Crude sludge and Calcium oxide. Crude sludge is the mixture of by-products of petroleum hydrocarbons refining (especially Total petroleum hydrocarbons, Polycyclic aromatic hydrocarbons, acid-refined heavy petroleum distillates). The Crude sludge is neutralised by calcium oxide in the ratio 80:20. The maturing process proceeds under ambient conditions and takes for at least 3 days. Subsequently, the reaction product is processed mechanically.
- Details on test material:
- - Name of test material (as cited in study report): Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide - Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Smiles notation: not known - UVCB substance
- InChl: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 26.2.2010
- Expiration date of the lot/batch: 26.2.2012
- Stability under test conditions: stable
- Storage condition of test material: The substance was stored in PE bottle at room temperature.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Weight at study initiation: 3.3-3.9 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet: pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy, Czech Republic))
- Water: drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: room temperature 17 - 23ºC, permanently monitored
- Relative humidity: 30 - 70 %, permanently monitored
- Photoperiod: 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: close clipping of the fur on the dorsal area
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Duration of treatment / exposure:
- Duration of exposure:
one animal: 3 min, 1 hour, 4 hours (three patches were applied sequentially to one animal)
two animals: 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: fur from area 6x6 cm was removed
- Type of wrap: gauze patch, foil and cellulose cotton and held in place with non-irritating tape Spofaplast
REMOVAL OF TEST SUBSTANCE
- Washing: by water
SCORING SYSTEM: Exposed rabbit was examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Scoring system - see Table bellow.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No evidence of a irritation/corrosion on the skin
- Other effects:
- No symptoms systemic toxicity.
No mortality.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The test substance was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test.
The test was performed according to the Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.
At first the test substance was applied on the skin of one rabbit. The skin of this rabbit was investigated 3 minutes, 1 hour and 4 hours after application of the test substance. No symptoms of irritation were observed on the skin.
In confirmatory test, two others rabbits were used with 4-hour exposition period. No evidence of a corrosive effect or symptoms of irritation were observed on the skin.
No other signs of intoxication were observed.
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