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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
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 group
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 group
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

No deaths occurred.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
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.