Registration Dossier
Registration Dossier
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EC number: 250-709-6 | CAS number: 31570-04-4
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- comparable to 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:
- 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).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 14 h/d light period. The eyes of three animals were washed after 30 s from treatment without justification.
- 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 / tissue source
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or tissues 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 30 s (3 rabbits)
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water (3 animals)
- Time after start of exposure: 30 s
SCORING SYSTEM:
Draize
TOOL USED TO ASSESS SCORE:
hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 d
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 2 d
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 d
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 0
- Max. score:
- 110
- Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The irritation index in this experiment was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
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