Registration Dossier
Registration Dossier
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EC number: 279-356-6 | CAS number: 79953-85-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Additional to an LLNA study with the test substance, a valid guinea pig maximization study with the read-across substance, CAS 68516-73-4, is available.
Test material
- Reference substance name:
- Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate
- EC Number:
- 271-176-6
- EC Name:
- Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate
- Cas Number:
- 68516-73-4
- Molecular formula:
- C34H32N6O12
- IUPAC Name:
- tetramethyl 2,2'-{1,4-phenylenebis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}diterephthalate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Yellow powder
Investing the test material with regard to its particle size is no longer possible (study performed 25 years ago). The data owner informed the lead registrant that the test material does not fulfill the criteria of a nanomaterial according to the EU definition.
No purity provided in study report.
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: 201P69495
- Expiration date of the lot/batch: 22-MAY-2005
- Stability under test conditions: stable
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: 4 - 6 weeks at delivery
- Weight at study initiation: 300 - 359 g
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (air conditioned room)
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2001-07-03 To: 2001-08-03
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 10% (intradermal)
30% (epicutaneous)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 10% (intradermal)
30% (epicutaneous)
- No. of animals per dose:
- 10 test group
5 control group - Details on study design:
- The intradermal induction of sensitization in the test group was performed in the nuchal region with a 10 % dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 30% in PEG 300 one week after the intradermal induction. The animals of the control group were intradermally induced
with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10% in PEG 300 and PEG 300 alone under occlusive dressing. - Challenge controls:
- CONTROL GROUP
TONER YELLOW 3GP, 10% in PEG 300 (left flank)
PEG 300 only (right flank)
TEST GROUP
TONER YELLOW 3GP, 10% in PEG 300 (left flank)
PEG 300 only (right flank) - Positive control substance(s):
- yes
- Remarks:
- 2-MERCAPTOBENZOTHIAZOLE
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
Any other information on results incl. tables
Challenge with vehicle only caused no skin reactions in the control group and test group, respectively.
CONTROL GROUP
No skin reactions were observed in the animals when treated with either PEG 300 only or when treated with the test item at 10% in PEG 300. Yellow discoloration produced by the test item was noted directly after removal of the patch.
TEST GROUP
No skin reactions were observed in the surviving animals when treated with either PEG 300 only or when treated with the test item at 10% in PEG 300. Yellow discoloration produced by the test item was noted directly after removal of the patch. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.
The body weight of the animals was within the range commonly recorded for animals of this strain and age. No clinical signs were observed. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.
One animal died during the study. No cause of death could be identified and no skin reactions were observed. The death is considered to be incidental.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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