Registration Dossier
Registration Dossier
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EC number: 947-663-0 | CAS number: -
Skin sensitisation
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:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Diacid 1550
- IUPAC Name:
- Diacid 1550
- Details on test material:
- - Name of test material (as cited in study report): Diacid 1550
- Lot/batch No.: Confidential
Constituent 1
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 chemical
- 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 chemical
- 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.
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