Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2 benzenedicarboxylic acid, di-C16-C18-alkyl esters
- CAS No. as cited in study report: 90193-76-3
- Batch: April 10th, 1992
- Physical state: light beige solid
- Analytical purity: no data
- Content of active substance: 100 %
- Stability under test conditions: stable for at least 1 year
- Storage condition of test material: at room temperature

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
induction: 30 %
challenge: 10 %
Challengeopen allclose all
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

Results and discussion

Positive control results:
No data reported.

In vivo (non-LLNA)

Resultsopen allclose all
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.

Any other information on results incl. tables

No deaths occurred.

Applicant's summary and conclusion

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