Registration Dossier
Registration Dossier
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EC number: 941-814-4 | CAS number: 157367-45-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1991 to January 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD guideline under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Magnusson & Kligmann maximisation study
Test material
- Reference substance name:
- 308 AQN
- IUPAC Name:
- 308 AQN
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Thirty-six female, albino Dunkin-Hartley guinea pigs were supplied by David Hall Limited, Burton-on-Trent, Staffordshire, U.K. At start of the main study the animals weighed 328 - 419g, and were approximately eight to twelve weeks old. After a minimum acclimatisation period of five days, each animal was selected at random and given a number unique within the study which was written on a small area of clipped rump using a black indelible marker-pen.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- PRETEST:
Intradermal induction: 1%, 5%
Topical induction: 5%, 10%, 25%, 50%
Topical challenge: 5%, 10%, 25%, 50%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- arachis oil
- Concentration / amount:
- PRETEST:
Intradermal induction: 1%, 5%
Topical induction: 5%, 10%, 25%, 50%
Topical challenge: 5%, 10%, 25%, 50%
- No. of animals per dose:
- PRETEST:
Intradermal induction: 2
Topical induction: 2
Topical challenge: 2 - Details on study design:
- RANGE FINDING TESTS: four preparations of the test material (50, 25, 10 and 5%) were allpied occlusively to both flanks for 24 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- Site: intradermal injections
- Frequency of applications: 1
- Concentrations: see above
B. CHALLENGE EXPOSURE
- Site: both flanks, clipped
- Concentrations: see above
- Evaluation (hr after challenge): 24 and 48h - Challenge controls:
- no
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 %
- 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: 2 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 %
- 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: 2 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
No signs of sensitisation were found.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EEC labeling
- Conclusions:
- The test material, No. 308 AQN, produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to quinea pig skin.
- Executive summary:
The test material, No. 308 AQN, produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to quinea pig skin.
The test material was also classified as a non-sensitiser according to ECC labeling regulations. No risk phrase is therefore required.
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