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EC number: 235-166-5 | CAS number: 12108-13-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-03-21-1990-05-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The postive control used is different than the one recommended by OECD 406 guidlines
- Principles of method if other than guideline:
- The positive control used is different than the one recommended by OECD 406 guidelines.
- GLP compliance:
- yes
- Remarks:
- Compliance statement
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study uindertaken before animal welfare restrictions were imposed.
Test material
- Reference substance name:
- Tricarbonyl(methylcyclopentadienyl)manganese
- EC Number:
- 235-166-5
- EC Name:
- Tricarbonyl(methylcyclopentadienyl)manganese
- Cas Number:
- 12108-13-3
- Molecular formula:
- C9H7MnO3
- IUPAC Name:
- tricarbonyl(methyl-η5-cyclopentadienyl)manganese
- Details on test material:
- - Name of test material (as cited in study report): mmt
- Physical state: Liquid
- Analytical purity: 98.27%
- Lot/batch No.: 2602-89
- Expiration date of the lot/batch: 1991-08-29
- Stability under test conditions: Keep material and solution in the dark
- Storage condition of test material: Original container, room temperature and in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Buckberg Lab Animals, Tomkins Cove, New York
- Age at study initiation:
- Weight at study initiation: 300-500 gr
- Housing: Guinea pigs were housed individually in stainless steel "wire mesh cages sized in accordance with "Guide for the care and use of Laborator y Animals" of the institute of Laboratory Animal Resources, National Research Concil. The study animals were housed under yellow light.
- Diet (e.g. ad libitum): Wayne Guinea Pig Diet, ad libitum, food was checked daily and added or replaced as needed. Feeders were designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): Availabity-fresh tap water, ad libitum
- Acclimation period: Minimum: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 0 To: 23 days
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction and Challenge: 100% mmt
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction and Challenge: 100% mmt
- No. of animals per dose:
- Substance - 20 (10 per sex)
Vehicle control group - 20 (10 per sex)
Positive control group- 6 (3 per sex) - Details on study design:
- RANGE FINDING TESTS:
Induction: 10, 25, 50 and 100% of the dose received in 0.9% saline
Challenge: 10, 25, 50 and 100% of the dose received in 0.9% saline
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: -
- Test groups: mmt with/without 0.9% FCA
- Control group: 0.1% DNCB with/without FCA
- Site: Flank
- Frequency of applications: second application at 6th day
- Duration: 0-7 days
- Concentrations: 100% of the dose received in 0.9% saline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3
- Exposure period: 24 hours
- Test groups: mmt
- Control group: DNCB
- Site: Flank
- Concentrations: as received
- Evaluation (hr after challenge): 24 hrs and 48 hrs - Challenge controls:
- 10 Males and 10 Females were used for the challenge control and the concentration of the test substance was 100%.
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- In the first 24 hrs of the challenge test, 4 out of 6 guinea pigs showed positive sensitization reactions to the positive control (DNCB). 48 hrs after the beggining of the test, 3 out of 6 test animals still presented positive reaction to DNCB (Slight patchy mild redness). In order for the test be valid, a minimum of 50% of the animals needed to show a reaction to the positive control.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- DNCB (0.1%)
- No. with + reactions:
- 4
- Total no. in group:
- 6
- Clinical observations:
- Slight patchy mild redness
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- DNCB (0.1%)
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- Slight patchy mild redness
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0.9% saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0.9% Saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
|
|
24 hours |
48 hours |
||
Animal # |
Sex |
Left flank |
Right flank |
Left flank |
Right flank |
mmt as received (left flank) 0.9% Saline (right flank) |
|||||
5059 |
M |
0 |
0 |
0 |
0 |
5060 |
M |
0 |
0 |
0 |
0 |
5061 |
M |
0 |
0 |
0 |
0 |
5062 |
M |
0 |
0 |
0 |
0 |
5063 |
M |
0 |
0 |
0 |
0 |
5064 |
M |
0 |
0 |
0 |
0 |
5065 |
M |
0 |
0 |
0 |
0 |
5066 |
M |
0 |
0 |
0 |
0 |
5067 |
M |
0 |
0 |
0 |
0 |
5068 |
M |
0 |
0 |
0 |
0 |
5069 |
F |
0 |
0 |
0 |
0 |
5070 |
F |
0 |
0 |
0 |
0 |
5071 |
F |
0 |
0 |
0 |
0 |
5072 |
F |
0 |
0 |
0 |
0 |
5073 |
F |
0 |
0 |
0 |
0 |
5074 |
F |
0 |
0 |
0 |
0 |
5075 |
F |
0 |
0 |
0 |
0 |
5076 |
F |
0 |
0 |
0 |
0 |
5077 |
F |
0 |
0 |
0 |
0 |
5078 |
F |
0 |
0 |
0 |
0 |
Total number of animals responding |
0 |
0 |
0 |
0 |
|
|
|
24 hours |
48 hours |
||
Animal # |
Sex |
Left flank |
Right flank |
Left flank |
Right flank |
DNCB (0.1%) (left flank) 0.9% Saline (right flank) |
|||||
5059 |
M |
1 |
0 |
1 |
0 |
5060 |
M |
0 |
0 |
0 |
0 |
5061 |
M |
0 |
0 |
0 |
0 |
5062 |
F |
1 |
0 |
1 |
0 |
5063 |
F |
1 |
0 |
1 |
0 |
5064 |
F |
1 |
0 |
0 |
0 |
Total number of animals responding |
4 (67%) |
0 |
3 (50%) |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information None of the test animals exhibited a skin sensitization reaction to mmt.
- Conclusions:
- mmt did not result in dermal sensitization in the Guinea Pig Sensitization Maximization Test.
- Executive summary:
The Guinea pig maximization test (Magnusson-Kligman) was performed to test the effect of mmt as a skin sensitizer. The study was performed similar to OECD 406 and EPA Health Effect Test Guidelines EPA 560/6-82-001. The Hartley strain of guinea pigs with a weight range of 300 to 500 grams, males and females, respectively were used in the study. A dose-range-finding study using the concentrations 10, 25, 500 and 100% of mmt, and based on those results, the test substance was dosed as received (100%) since no skin irritation effects were elicited in all the concentrations tested. One week following the intradermal administration, treatment groups were induced topically challenged in the same manner at naive sites. A positive response (Slight patchy mild redness) was elicited in the animals receiving 1 -chloro-2,4 -dinitrobenzene at the challenge period. No responses were observed in the animals receiving mmt or the vehicle control. Based upon the observations made, the mmt did not cause dermal sensitization in guinea pigs.
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