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Registration Dossier
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EC number: 290-580-3 | CAS number: 90193-76-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Jun - 20 Aug 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- : test group only 10 instead of 20 animals, reliability check was performed more than 1 year before and not reported here
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid Buehler test from 1992 was available, therefore no additional LLNA test was performed.
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany.
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: approx. 320 g
- Housing: 2-3 animals in Makrolon Type IV cages with standard softwood bedding
- Diet (e.g. ad libitum): Altromin Maintenance Diet 3022, Lage, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- induction: 30 %
challenge: 10 % - Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- induction: 30 %
challenge: 10 % - No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
yes, 10, 20, 30, 40, 70 and 100 % of the test substance (0.08 mL each) in olive oil were applied to the flank of three guinea pigs.
A 10% concentration was found to be the maximum non-irritating dose for challenge-treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 10 animals, TS
- Control group: 10 vehicle controls.
- Site: left cranial flank
- Frequency of applications: weekly
- Duration: 3 weeks
- Concentrations: 30 % (minimum irritating dose level), 0.5 mL were applicated per plaster.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the 3rd induction
- Exposure period: 6 hours
- Test groups: 10, TS
- Control group: 10, TS
- Site: bilateral caudal flank
- Concentrations: 10 % (maximum non irritating dose level)
- Evaluation (hr after challenge): 24 and 48 hours after exposure termination
OTHER: Dose-finding exposure:
5 animals of the control group were treated on the right flank with 5, 10 an 15% (0.5 mL) of the test substance for 6 hours and skin examination followed 24 and 48 hours after exposure termination. - Challenge controls:
- Reliability check was performed in April 1991 (report TBD 910161)
- Positive control substance(s):
- not specified
- Positive control results:
- No data reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Group:
- positive control
- Remarks on result:
- other: no data reported
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
No deaths occurred.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
1,2 Benzenedicarboxylic acid, di-C16-C18-alkyl esters (CAS No. 90193-76-3) was tested for its skin sensitisation potential according to OECD 406 (Pittermann, 1992). 10 guinea pigs were tested in a Buehler test. Concentrations for induction and challenge were defined in a preliminary experiment. Induction exposure was performed with the test substance at a concentration of 30 % in olive oil for epicutaneous application. Challenge treatment was performed by dermal application of the test substance at 10 % in olive oil. 24 and 48 hours after challenge exposure all skin examination scores in the test groups were zero. Based on this study results, 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters exerted no skin-sensitising potential.
Migrated from Short description of key information:
The available skin sensitisation study showed that 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters is not skin sensitising.
Justification for selection of skin sensitisation endpoint:
There is only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on the skin sensitisation potential do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
There are no data available on respiratory sensitisation.
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