Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Aug 2014 - 24 Nov 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: ElmSam:HA
- Sex:
- male
- Details on test animals and environmental conditions:
- Temperature : (20.5-22.8)℃
Relative humidity : (49.0-57.7)% R.H.
Air exchange : (10-20)/h
Light cycle : Light 12h(08:00-20:00)
Dark 12h(20:00-08:00)
Illumination : (150-300)Lux
Cage style : Stainless steel wire cage
Quarantine cage size : (700W x 475D x 200H) mm
Experiment cage size : (540W x 610D x 200H)mm
Animal per cage : Less than 5
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% Ethanol
- Concentration / amount:
- Concentrations:
INDUCTION
Treatment : 25%(w/v) test substance
Negative control : 80% Ethanol
Positive control : 1%(w/v) DNCB
CHALLENGE:
Treatment : 25%(w/v) test substance
Negative control : 25%(w/v) test substance
Positive control : 1%(w/v) DNCB
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% Ethanol
- Concentration / amount:
- Concentrations:
INDUCTION
Treatment : 25%(w/v) test substance
Negative control : 80% Ethanol
Positive control : 1%(w/v) DNCB
CHALLENGE:
Treatment : 25%(w/v) test substance
Negative control : 25%(w/v) test substance
Positive control : 1%(w/v) DNCB
- No. of animals per dose:
- Treatment : 20
Negative control : 10
Positive control : 10 - Details on study design:
- Induction exposure
- No. of exposure : 3
- Exposure period : 6h
- Test groups : 3
- Site : The fur on one flank [(4*6)cm2]
- Frequency of application : day 0, 7, 14
- Duration : induction period continues to day 21
- Observation : Approximately 21hours after removing the patch of the challenge area - Challenge controls:
- Induction exposure
- No. of exposure : 1
- Exposure period : 6h
- Test groups : 3
- Site : The untreated flank of treated and control animals
- Frequency of application : day 27
- Duration : induction period continues to day 29
- Observation : Approximately 21hours after removing the patch of the challenge area - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene(DNCB)
Results and discussion
- Positive control results:
- See table 1, below.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%(w/v) test substance in Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB in Ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%(w/v) DNCB in Ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB in Ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1%(w/v) DNCB in Ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.
Any other information on results incl. tables
Table 1. Evaluation of skin reaction
| Group | Number of animals | Observation time | Score of skin reaction | Mean score | Semsotosatopm rate(%) | |||
| 0 | 1 | 2 | 3 | |||||
| Test substance group | 20 | 24 | 20* | 0 | 0 | 0 | 0.0 | 0.0 |
| 48 | 20 | 0 | 0 | 0 | 0.0 | 0.0 | ||
| Negative control | 10 | 24 | 10 | 0 | 0 | 0 | 0.0 | 0.0 |
| 48 | 10 | 0 | 0 | 0 | 0.0 | 0.0 | ||
| Positive control | 10 | 24 | 1 | 5 | 4 | 0 | 1.3 | 90.0 |
| 48 | 2 | 7 | 1 | 0 | 0.9 | 80.0 | ||
* : Number of animals showing the score
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- These results indicate that this test substance is considered to have no skin sensitizing potency of Red 620 in guinea pigs by Buehler test under the conditions of this study.
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