Registration Dossier
Registration Dossier
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EC number: 416-140-4 | CAS number: 145650-60-8 IRGAFOS 38
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-08-11 to 1993-01-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (OECD Guideline 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted on 17-Jul-1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- EC Number:
- 416-140-4
- EC Name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- Cas Number:
- 145650-60-8
- Molecular formula:
- C32H51 O3 P
- IUPAC Name:
- bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite
- Details on test material:
- Physical properties: Solid, white
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: CIBA-GEIGY LTD. Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 323 to 423 g
- Housing: individually in Macrolon cages
- Diet: ad libitum standard guinea pig pellets
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 30 to 70%
- Photoperiod: 12 hrs light cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline, arachis oil, physiol. saline
- Concentration / amount:
- Intradermal Induction: test substance in arachis oil and adjuvant mixture: 5%
Epidermal Induction: test substance 50 % in vaseline
Epidermal Challenge: test substance 50 % in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline, arachis oil, physiol. saline
- Concentration / amount:
- Intradermal Induction: test substance in arachis oil and adjuvant mixture: 5%
Epidermal Induction: test substance 50 % in vaseline
Epidermal Challenge: test substance 50 % in vaseline
- No. of animals per dose:
- test group: 10 male and 10 female guinea pigs
control group: 5 male and 5 female guinea pigs - Details on study design:
- RANGE FINDING TESTS
The concentration of the test compound for the induction and challenge periods were determined on four separate animals with concentrations of 1 %, 5 %, 10 %, 20%, 30% and 50%. The tested concentrations did not induce erythema reactions, therefore a concentration of 50% in vaseline was selected. No skin irritation was observed in the pretest. Therefore the application site was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. Concentration of test article for challenge was also 50% in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two-stage operation
- Exposure period: weeks 1 and 2
- Site: First, three pairs of intradermal injections into the neck region (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) were given. Second, closed patch exposure over the injection sites one week later.
During weeks 3 and 4 no treatments were performed.
B. CHALLENGE EXPOSURE
- Exposure period: week 5
- Test and control groups: test substance in vaseline (w/w)
- Site: on the flank (occluded administration for 24 hrs) - Challenge controls:
- A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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