Registration Dossier
Registration Dossier
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EC number: 271-094-0 | CAS number: 68515-51-5
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:
- key study
- Study period:
- 1990-09-10 to 1990-10-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, read-across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Witamol 118
- IUPAC Name:
- Witamol 118
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- EC Number:
- 275-809-7
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- Cas Number:
- 71662-46-9
- IUPAC Name:
- 71662-46-9
- Details on test material:
- - Name of test material (as cited in study report): WITAMOL 118
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: below 40 °C, under nitrogen under a laboratory hood in the dark
- Other: none
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley, Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 382-487 g
- 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: 14 days (main test)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 40 - 77
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: approx. 5 % in corn oil; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): approx. 5 % test substance in a mixture of FCA and corn oil (1:1)
- Concentrations used for challenge: 100 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: approx. 5 % in corn oil; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): approx. 5 % test substance in a mixture of FCA and corn 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 dose range finding was performed in a preliminary study. 0.1 ml of test substance in corn oil (0, 0.1, 0.5, 1, 2.5, 5 and 10 g test substance/100 ml corn oil) were applied intracutaneously into the left side of two animals. 24 hours after application the skin reactions were assessed. For dermal applications undiluted test substance and concentrations of 10, 20 and 50 g test substance/100 ml corn oil were applied on patches of 2x2 cm to the clipped skin of 4 animals. The patches were removed after 24 hours and dermal reactions were read immediately, 24 and 48 hours after patch removal.
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): test substance in vehicle (5g/100 cm³) in a mixture of FCA and vehicle (1:1)
- Test group: dermal: 100 % test substance (2 x 4 cm patch)
- Control group: vehicle (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
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 100 %
- Evaluation: 24, 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
RESULTS OF PILOT STUDY:
- intracutaneous application: well defined erythema and moderate edema at concentrations of 10 g test substance /100 ml corn oil. At concentrations of 0, 0.1, 0.5, 1, 2.5, 5 and 10 g test substance/100 ml corn oil very slight erythema and moderate edema were observed.
- dermal application: no skin reactions at any dose
RESULTS OF TEST
- Sensitization reaction: 0/20
- Clinical signs: no substance specific observations
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
The structurally related substance 1,2-Benzenedicarboxylic acid, mixed decyl and lauryl diesters was not sensitising.
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