Registration Dossier
Registration Dossier
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EC number: 231-545-4 | CAS number: 7631-86-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24-h exposure + including abraded skin
- Qualifier:
- according to guideline
- Guideline:
- other: Patch-Test; Hazardous Substances, Part 191, Section 11, FDA, Washington, 1965
- Deviations:
- yes
- Remarks:
- Exposure time 24 hours
- Principles of method if other than guideline:
- 1 dose level, 24-hour application on intact and abraded skin, 14-day post observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- CAS-Name: Silica, amorphous, fumed, cryst.-free; CAS-No.: 112945-52-5
Constituent 1
- Specific details on test material used for the study:
- amorphous silicon dioxide Aerosil 200
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: 2.3 - 2.8 kg
- Housing: V2A steel cages
- Diet: Altomin 2023, ad libitum except treatment day
- Water: tap water, ad libitum except treatment day
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-2 °C
- Humidity (%): 60 +- 3
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hrs
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- other: 12-% suspension/gel in 1-% methyl-hydroxyethyl cellulose 300 P
- Controls:
- no
- Amount / concentration applied:
- Dose: 0.5 g
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 6 (intact skin)
6 (abraded skin) - Details on study design:
- TEST SITE
- Area of exposure: approx. 2.5 cm x 2.5 cm
- Type of wrap if used: plasic foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h
SCORING SYSTEM:
Draize scoring scheme for grading skin effects (erythema and oedema)
Time: 24 and 72 h (0 and 48 h after termination of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 - #6
- Remarks:
- intact skin
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1 - #6
- Remarks:
- intact skin
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: #7 - #12
- Remarks:
- abraded skin
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #7 - #12
- Remarks:
- abraded skin
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- intact & abraded skin
- Time point:
- other: 24, 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no signs of irritation.
- Other effects:
- There were no clinical signs observed. Behaviour, grooming, food intake and body weight were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no dermal irritation observed with amorphous silicon dioxide Aerosil 200
- Executive summary:
The skin irritation potential of amorphous silicon dioxide Aerosil 200 was evaluated in rabbits.
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