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Skin sensitisation
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Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method had not yet been adopted when this study was performed.
Test material
- Test material form:
- solid: granular
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6X07A106
- Expiration date of the lot/batch: May 16, 1997
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test substance was dispersed in cold water, then heated to 80 degrees C for 10 minutes.
- Final dilution of a dissolved solid, stock liquid or gel: 10% and 30% dilution in water
FORM AS APPLIED IN THE TEST (if different from that of starting material): solution
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 2-3 weeks
- Weight at study initiation: 175-400 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Day(s)/duration:
- one week
- Adequacy of induction:
- other: Concentration in dermal application was highest tolerable irritating concentration with pretreatment with sodium lauryl sulfate.
- Route:
- intradermal
- Vehicle:
- other: FCA and vehicle 1:1
- Day(s)/duration:
- 1 Day
- Adequacy of induction:
- other: selected test concentration
- Route:
- intradermal
- Vehicle:
- other: FCA and isotonic saline 1:1
- Concentration / amount:
- 0%
- Day(s)/duration:
- 1 Day
Challenge
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 10% and 30%
- Day(s)/duration:
- 14 days after last induction
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 males and 5 females in the test group.
3 males and 3 females in the control group. - Details on study design:
- RANGE FINDING TESTS:
A preliminary study was performed to determine the highest tolerated concentration. Three animals were injected intradermally with 1%, 3%, 10%, and 30% test substance in water. 30% was the highest concentration that could be injected. All animals showed necrosis at the 3%, 10%, and 30% injection sites at the 24 hr observation. At the 1% injection sites, all animals were given a dermal irritation score of 2, and abscesses were noted at 24 hrs after injection. Another three animals were tested by topical application at 10% and 30% test substance. No animals showed any irritation at either the 24 or 48 hr readings.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 2 exposures 1 week apart
- Test groups: Test animals were injected with a solution of 1:1 FCA/isotonic saline, 0.3% test substance in water, and 0.3% test substance in FCA/water 1:1. One week later they were pretreated with SLS and given topical applicaiton of 30% test substance.
- Control group: Control animals were injected with a solution of 1:1 FCA/isotonic saline, water, and FCA/water 1:1. One week later they were pretreated with SLS and given topical applicaiton of water or empty patches.
- Concentrations: 10% and 30%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction exposure
- Test groups: Topical application of 10% and 30% test substance.
- Control group: Topical application of 10% and 30% test substance.
- Concentrations: 10% and 30%
- Evaluation (hr after challenge): 24 and 48 hrs after removal of the patches. - 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:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% and 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% and 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Dermal Reaction Scores In Challenge Test
Animal |
24 hrs |
48 hrs |
Control Group |
0 |
0 |
76 |
0 |
0 |
78 |
0 |
0 |
80 |
0 |
0 |
75 |
0 |
0 |
77 |
0 |
0 |
79 |
0 |
0 |
10% Test Substance |
0 |
0 |
66 |
0 |
0 |
68 |
0 |
0 |
70 |
0 |
0 |
72 |
0 |
0 |
74 |
0 |
0 |
65 |
0 |
0 |
67 |
0 |
0 |
69 |
0 |
0 |
71 |
0 |
0 |
73 |
0 |
0 |
30% Test Substance |
0 |
0 |
66 |
0 |
0 |
68 |
0 |
0 |
70 |
0 |
0 |
72 |
0 |
0 |
74 |
0 |
0 |
65 |
0 |
0 |
67 |
0 |
0 |
69 |
0 |
0 |
71 |
0 |
0 |
73 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LMD is not sensitizing to skin.
- Executive summary:
The skin sensitization potential of LMD was tested in an OECD Guideline 406 study. 5 male and 5 female guinea pigs were exposed to the test substance intradermally, and topically in exposures one week apart. A control group was exposed to vehicles only. 2 weeks later, both groups were exposed to the 10% and 30% of the test substance topically. No reactions were seen in any animals during the challenge exposure. The test substance is therefore not sensitizing to skin.
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