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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
Study period:
December 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Buehler, EV. Delayed contact hypersensitivity in the guinea pig. Arch Dermat 91, February 1965.
Deviations:
not specified
Principles of method if other than guideline:
no data
GLP compliance:
no
Remarks:
(study performed prior to GLP)
Type of study:
Buehler test
Justification for non-LLNA method:
The study was perfomed before the LLNA method was approved and it is considered relevant and conclusive.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diacid 1550
- Lot/batch No.: Confidential

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Range-finding: 0.1, 1.0 and 10.0% (w/v) solution of Diacid 1550 in Propylene Glycol and undiluted
Main study: 0.1% (w/v) solution of Diacid 1550 in Propylene Glycol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Range-finding: 0.1, 1.0 and 10.0% (w/v) solution of Diacid 1550 in Propylene Glycol and undiluted
Main study: 0.1% (w/v) solution of Diacid 1550 in Propylene Glycol
No. of animals per dose:
Range-finding: 2 animals per dose
10 animals in the test group and 4 animals in the control group
Details on study design:
RANGE FINDING TESTS:
0.1%, 1.0%, 10.0% and undiluted Diacid were tested to establish the irritation threshold of the material. The maximum non-irritating concentration of the test material was used during induction and challenge exposure.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Test groups: 10 guinea pigs
- Control group: 4 guinea pigs
- Site: near the midline of the shaved back of the guinea pig
- Frequency of applications: 9
- Duration: 6 hours
- Concentrations: 0.1 % (w/v) solution of Diacid in proylene glycol

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: five weeks after the initial exposure
- Test groups: 10 guinea pigs
- Control group: 4 guinea pigs
- Site: No information available, duplicate patches applied
- Concentrations: 0.1% (w/v) solution of Diacid 1550 in propylene glycol
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
Four control animals were not treated during the induction phase and treated during challenge phase (negative controls).
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1%
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: 0.1%. 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:
0.1%
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: 0.1%. 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:
0.1%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.
Reading:
other:
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

The application sites were graded 24 and 48 hours after the initial insult, 24 and 48 hours after each intermediate insult, and 24 and 48 hours after challenge. None of the animals showed any signs of erythema or edema.

Results of the range-finding test are presented in the table below.

Test material concentration

Animal number

Scores following application

Site 1

Site 2

24 hr

48 hr

24 hr

48 hr

Er.

Ed.

Er.

Ed.

Er.

Ed.

Er.

Ed.

0.1%

1

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

1.0%

3

1

0

1

0

1

0

1

0

4

1

0

1

0

1

0

1

0

10.0%

5

2

0

2

0

2

0

2

0

6

2

0

2

0

2

0

2

0

Undiluted

7

3

2

3

2

3

2

3

1

8

3

2

3

2

3

2

3

2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin sensitisation test according to Buehler, 0.1% Diacid 1550 in propylene glycol did not induce skin sensitisation in albino guinea pigs under the conditions of this test.
Executive summary:

A skin sensitisation study was performed in accordance with the Buehler method to determine the skin sensitising potential of Diacid 1550. Ten albino guinea pigs were used. During induction, each animal was insulted with a single closed patch containing 0.1% Diacid 1550, for a total of nine times. Five weeks after the initial exposure, the 10 test animals and 4 previously untreated controls were challenged with duplicate patches. The application sites were graded for skin reactions 24 and 48 hours after the initial insult, after each intermediate insult and after challenge. None of the exposed animals showed any skin reactions. Thus, the substance was found negative in this in vivo study for skin sensitisation.