Registration Dossier
Registration Dossier
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EC number: 273-489-3 | CAS number: 68987-29-1
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: Read-across from an acceptable study report, which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 hour exposure under occlusive dressing
- GLP compliance:
- no
Test material
- Reference substance name:
- Phosphoric acid, C16-18-alkyl esters, potassium salts
- EC Number:
- 291-907-2
- EC Name:
- Phosphoric acid, C16-18-alkyl esters, potassium salts
- Cas Number:
- 90506-45-9
- IUPAC Name:
- 90506-45-9
- Details on test material:
- Silastol 11137, white creamy substance
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean 2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit diet (Höing 222) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 1 °C
- Humidity (%): 50 -60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour dark/ light cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and shaved area
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plaster fixed with Leukoplast tape, covered with an occlusive dressing.
SCORING SYSTEM: Draize scoring system
Shaved/abraded and only shaved areas were used for exposure with test substance, the same areas were used for control
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Shaved site
Time point |
Erythema Max score 4 |
Edema Max score 4 |
24 hours |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 hours |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24 and 72 hours |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Reversibility*)
|
c/c/c |
c/c/c |
Average time (unit) for reversion |
- |
- |
*) Reversibility: c. = completely reversible
abraded site
Time point |
Erythema Max score 4 |
Edema Max score 4 |
24 hours |
1/0/1/1/0/1 |
0/0/0/0/0/0 |
72 hours |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24 and 72 hours |
0.5/0/0.5/0.5/0/0.5 |
0/0/0/0/0/0 |
Reversibility*)
|
c/c/c |
c/c/c |
Average time (unit) for reversion |
72 hours |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP; EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Classification is based on individual mean scores of 24 and 72 hour scorings, considering reversibility.
- Executive summary:
In a primary dermal irritation study, New Zealand White were dermally exposed Silastol 11137 (undiluted) to for 24 hours under an occlusive dressing to shaved and shaved and abraded skin areas. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.
On shaved areas no irritation was observed in all animal whereas on the abraded areas in 4/6 animals erythema score 1 was observed at the 24 hour reading. Effects were reversible within 72 hours.
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