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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is rated a "1" because it applied GLP, used appropriate testing procedures, and followed an accepted test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Principles of method if other than guideline:
Method: other: Directive 92/69/EEC, B.6
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A modification of the Buehler method (Buehler, 1965) was employed. Other study records for this endpoint include a Draize patch test as well. Therefore the endpoint was adequately assessed and from an animal welfare standpoint conducting an additional LLNA is not necessary

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
EC Number:
271-091-4
EC Name:
1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
Cas Number:
68515-49-1
Molecular formula:
C28 H46 O4
IUPAC Name:
1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10 rich
Constituent 2
Reference substance name:
1,2-benzenedicarboxylic acid, di-C9,C10 and C11 branched alkyl ester, C10 Rich
IUPAC Name:
1,2-benzenedicarboxylic acid, di-C9,C10 and C11 branched alkyl ester, C10 Rich
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D Hall, Newchurch, Staffordshire, England
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 283-343 g
- Housing: groups of 5 in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): vitamin C enriched guinea-pig diet FD1 ad libitum. Hay was given weekly
- Water: ad libitum
- Acclimation period: 11 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 13-07-1994 To: 18-08-1994

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
As supplied
Challenge
Concentration / amount:
As supplied
No. of animals per dose:
20 animals/dose
Details on study design:
1st application: Induction undiluted 2nd application: Challenge undiluted
RANGE FINDING TESTS:
A topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration for the challenge phase. Concentrations tested included 100, 80, 60, 40% v/v. The concentration of test substance was based on the results of the preliminary investigations. This was the maximum practical concentration and did not give rise to irritating effects.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6hrs each
- Test groups: 1
- Control group: 1
- Site: skin of the left shoulder region, clipped free of hair
- Frequency of applications: once per exposure
- Concentrations: as supplied
- Evaluation (hr after removal of patches): 30 minutes, and 24 hours

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: challenge occurred 2 weeks following the final induction application
- Exposure period: 6hrs
- Test groups: 1
- Control group: 1
- Site: skin of the left shoulder region, clipped free of hair
- Concentrations: as supplied
- Evaluation (hr after challenge): 24, 48, and 72 hours
Positive control substance(s):
yes
Remarks:
formalin

Results and discussion

Positive control results:
Positive control results were used from Huntingdon's historical data. In a study Huntingdon conducted in 1993, 10/10 test animals were positive following 3 inductions with formalin at concentrations of 25 or 30% (aqueous dilutions) and challenge at a concentration of 15%.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
neat
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: neat. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
neat
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: neat. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
neat
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: neat. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 % DNCB
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
erythmia and edema
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% DNCB
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
erythmia and edema
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
There were no dermal reactions observed in control or test animals following induction or challenge application. Therefore, the test substance did not produce evidence of skin sensitization (delayed contact hypersensitivity) in any animals.
Executive summary:

In a Buehler test conducted with Jayflex DIDP (composition not available to the laboratory) in 40 Guinea pigs (20 treated and 20 controls), undiluted substance was applied during induction phases (day 1, 8 and 15) and challenge (day 28), no sign of sensitisation was reported. No sign of irritation was reported during the induction period. This study was conducted in compliance with Method B6 of directive 92/69/EEC and performed according to GLP procedures.