Registration Dossier
Registration Dossier
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EC number: 250-709-6 | CAS number: 31570-04-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975-06
- 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:
- 1 975
- Report date:
- 1975
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 14 h/d light period. Occlusive dressing. Vehicle not specified. Dose not specified. 24 h exposure.
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
Test material
- Reference substance name:
- Tris(2,4-ditert-butylphenyl) phosphite
- EC Number:
- 250-709-6
- EC Name:
- Tris(2,4-ditert-butylphenyl) phosphite
- Cas Number:
- 31570-04-4
- Molecular formula:
- C42H63O3P
- IUPAC Name:
- tris(2,4-ditert-butylphenyl) phosphite
- Details on test material:
- - Substance type: organic- Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food (NAFAG, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: not mentioned
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified
VEHICLE
- Amount(s) applied (volume or weight with unit): not specified - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: entire back and the flank
- Type of wrap if used: impermeable material fastened to the body of the rabbit with adhesive tape
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary irritation index, a measure of the acute irritation to the rabbit skin was 0. This indicates that the substance is not an irritant to the rabbit skin.
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