Registration Dossier
Registration Dossier
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EC number: 458-670-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 96/54/EG, B.6 (Meerschweinchen-Maximierungstest (GPMT); OECD 406
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- other: gpg Crl(HA)
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in sesame oil
b) dermal: 25 % in sesame oil
Concentration of test material and vehicle used for each challenge:
dermal 25 % in sesame oil
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in sesame oil
b) dermal: 25 % in sesame oil
Concentration of test material and vehicle used for each challenge:
dermal 25 % in sesame oil
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
Intradermal injections with Freund's Adjuvant (with and
without test substance) caused well-defined erythema and
edema as well as indurations and encrustations. The
administrations sites treated with the test substance in
sesame oil showed well-defined up to slight erythema and
edema. Intradermal injections of the vehicle alone exhibited
no signs of irritation.
After dermal induction, well-defined edema, indurated and
encrusted skin as well as sproadically open wounds were
observed at the sites previously treated with Freund's
Adjuvant. The administrations sites treated with the test
substance alone showed slight erythema and edema. The
administration sites treated with the vehicle alone showed
no signs of irritation.
Evidence of sensitisation of each challenge concentration:
Test group: 10/10
Controll group: 0/5
Other observations:
The body weight gains of the animals were not impaired. The
treated animals showed no clinical signs of intoxication
throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the test result the test substance is classified as Skin Sens cat 1B, H317.
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