Registration Dossier
Registration Dossier
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EC number: 250-709-6 | CAS number: 31570-04-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-05-28 - 1979-07-24
- 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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Light period of 10 hours light. incomplete series of induction in test and control groups.
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. Guinea Pig optimization tests like the Maurer optimization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines.
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, white powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd. Grimston, Hull, England
- Weight at study initiation: 380 - 500 g
- Housing: individually in Macrolon cages, type 3
- Diet (e.g. ad libitum): ad libitum, standard guinea pig pellets (NAFAG, No. 830, Gossau SG)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- on Day 35, duration 24h
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- On day 45; duration 24h
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: -
- Test groups: test substance + vehicle (first week) and test substance + vehicle:FCA (1:1) (second and third week)
- Control group: vehicle
- Site: right flank and back
- Frequency of applications: every second day (except weekends)
- Duration: 0-21 d- Concentrations: 0.1 %
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 35 and 45
- Exposure period: -
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24 - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- one animal (male) died
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 10
- Total no. in group:
- 19
- Clinical observations:
- one animal (male) died
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Clinical observations:
- one animal (female) died
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.
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