Registration Dossier
Registration Dossier
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EC number: 273-381-6 | CAS number: 68958-92-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (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:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum
- EC Number:
- 273-381-6
- EC Name:
- Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum
- Cas Number:
- 68958-92-9
- Molecular formula:
- C32H68Mo2O6P2S6
- IUPAC Name:
- Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 20.1 - 23.4 g
- Housing: in groups up to five animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 48 - 69
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: substance is liquid and missible with the vehicle
- Irritation: no
- Systemic toxicity: no
- Ear thickness measurements: yes
- Erythema scores: no
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA (OECD 429)
- Criteria used to consider a positive response: stimulation index (SI) was calculated based on DPM values; SI >= 3 indicates a sensitising potential
TREATMENT PREPARATION AND ADMINISTRATION:
the test substance was applied on three consecutive days on the dorsal surface of both ears (25 µl/ear) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 25% concentration
- Key result
- Parameter:
- SI
- Value:
- 2.2
- Test group / Remarks:
- 50% concentration
- Key result
- Parameter:
- SI
- Value:
- 3
- Test group / Remarks:
- 100% concentration
- Remarks on result:
- other: see "Any other information on results"
Any other information on results incl. tables
In this LLNA test at the highest dose of 100% test substance applied to the ears the calculated SI value reached the value of 3.0. However, the vehicle control group of this study showed a very low mean DPM value, amounting to 223 DPM. In a parallel LLNA test performed at the same time, with the same batch of animals and vehicle, in the vehicle control group the DPM value amounted to 532 (copies of the tables showing the DPM values of both studies are attached).
The DPM value of the vehicle control group was very low due to three animals having DPM values between 109 and 154. The two other animals of the control group had DPM values of 358 and 375. The DPM values of the five vehicle control animals of the parallel study had DPM values ranging from 375 to 706. These data show that (1) a brought range of DPM values in vehicle control animals is determined (from 109 to 706) and (2) that the random distribution of animals can lead to high variations of DPM values in control groups. The exchange of just one control animal between the two vehicle control groups would have resulted in a calculated SI value below 3.0. An increase of only 10 DPM of the mean DPM value of the vehicle control group, i.e. from 223 DPM to 233 DPM, results in an SI value < 2.9.
Taking these statistical and mathematical considerations together it is concluded that the SI value of 3.0 as calculated in this study is a borderline case not leading to classification of S-930 as having a skin sensitising potential.
Applicant's summary and conclusion
- Interpretation of results:
- other: no skin sensitising potential
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