Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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
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

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.