Registration Dossier
Registration Dossier
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EC number: 201-877-4 | CAS number: 89-04-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- from 1989-11-28 to 1989-12-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation. For read-across justification see Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study undertaken prior to the introduction of the LLNA (OECD TG 429 originally adopted April 2002)
Test material
- Reference substance name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- EC Number:
- 268-007-3
- EC Name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- Cas Number:
- 67989-23-5
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- Reference substance name:
- 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters
- EC Number:
- 290-754-9
- EC Name:
- 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters
- Cas Number:
- 90218-76-1
- Molecular formula:
- C33H51O6 to C39H66O6
- IUPAC Name:
- tris(mixed decyl and octyl)benzene-1,2,4-tricarboxylate
- Details on test material:
- - Name of test material (as cited in study report): Witamol 218
- Physical state: liquid
- Nominal molecular formula (if other than submission substance): C35 H58 O6
- Nominal molecular weight (if other than submission substance): 574.85
- Nominal Smiles notation (if other than submission substance): O=C(c1ccc(cc1C(=O)O)C(=O)OCCCCCCCC)OCCCCCCCCCC
- Nominal InChl (if other than submission substance): 1S/C27H42O6/c1-3-5-7-9-11-12-14-16-20-33-27(31)23-18-17-22(21-24 (23)25(28)29)26(30)32-19-15-13-10-8-6-4-2/h17-18,21H,3-16,19-20H2,1-2H3, (H,28,29)
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 380 g (mean weight of the test animals); 376 g (mean weight of the control animals)
- Housing: 1 - 5 animals in Makrolon cages type IV
- Diet (e.g. ad libitum): G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: maize germ oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 10% test substance in maize germ oil; dermal treatment: 100% test substance
- Concentration in Freunds Complete Adjuvant (FCA): 10% test substance in a mixture of FCA and maize germ oil (1:1)
- Concentrations used for challenge: 100 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: maize germ oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 10% test substance in maize germ oil; dermal treatment: 100% test substance
- Concentration in Freunds Complete Adjuvant (FCA): 10% test substance in a mixture of FCA and maize germ oil (1:1)
- Concentrations used for challenge: 100 %
- No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
A test substance concentration of 100% were tested in a preliminary study, no further details were mentioned
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; evaluation after 1 and 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): 10% test substance in a mixture of FCA and maize germ oil (1:1)
- Test group: dermal: undiluted test substance (2 x 4 cm patch)
- Control group: maize germ oil (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with sodium dodecyl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: 3 weeks
- Concentrations: 100% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: undiluted test substance (2 x 2 cm patch)
- Control group: undiluted test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 100% v/v
- Evaluation (hr after challenge): 48 and 72 hours after application - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
RESULTS OF PILOT STUDY: no irritation at concentrations of 100% test substance
RESULTS OF TEST
- Sensitization reaction: 0/20
- Clinical signs: Local reactions after intradermal application (test and control animals after 1 and 24 hours): All FCA treated injections sites showed severe erythema, edema and necrosis. The animals treated with 10% test substance in maize germ oil showed well defined erythema and edema.
Local reactions after patch test (48 hours): 1 hour after patch removal, test and control animals: whole application area showed erythema and edema, as well as inflamed or bloody lesions, restlessness of the animals and scratching in the application area.
24 hours after patch removal: Some animals showed erythema and eschar formation in the whole application area.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters showed no sensitising effect on guinea pig skin under the described test conditions.
- Executive summary:
A structural analogue of the substance (1,2,4 -Benzenetricarboxylic acid, mixed decyl and octyl triesters) has been tested for dermal sensitisation in guinea pigs by the Magnusson and Kligman maximisation test according to OECD guideline 406. No response was observed at challenge and, on the basis of these results, the substance was regarded as having no sensitising effect on the skin of guinea pigs.
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