Registration Dossier
Registration Dossier
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EC number: 212-058-6 | CAS number: 757-86-8
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:
- From 09-11-1992 to 20-12-1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Methyl [(dimethoxyphosphinothioyl)thio]acetate
- EC Number:
- 212-058-6
- EC Name:
- Methyl [(dimethoxyphosphinothioyl)thio]acetate
- Cas Number:
- 757-86-8
- Molecular formula:
- C5H11O4PS2
- IUPAC Name:
- methyl 2-{[dimethoxy(sulfanylidene)-λ⁵-phosphanyl]sulfanyl}acetate
- Details on test material:
- - Name of test material (as cited in study report): MPEM
- Substance type: Intermediate
- Physical state: Liquid
- Purity test date:
- Lot/batch No.: 20825
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding Centre Ltd, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 296-563 g
- Housing: opaque PPL (Type IV) cages, two or three to a cage
- Diet (e.g. ad libitum): ad libitum pelleted diet, "3113 and 3122 Altromin" from Altromin GmbH D-4937 Lage- Germany
- Water (e.g. ad libitum): ad libitum, enriched with vitamin C and acidified to pH 2,5 with HCL
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): 10 times pr. hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- Intradermal: 5 % (w/w) (and 10 % (w/w) in FCA, 1:1
Dermal: 100 % (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Intradermal: 5 % (w/w) (and 10 % (w/w) in FCA, 1:1
Dermal: 100 % (w/w)
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: Induction exposure, intradermal: 10 % (w/w), 5 % (w/w), 2,5 % (w/w), 1,25 % (w/w)
Challenge exposure, dermal: 100 % (w/w) and 50 % (w/w)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, induction intradermal and induction dermal
- Exposure period: induction intradermal on Day 0 and induction dermal on day 7
- Test groups:
Induction intradermal: Injection 1: FCA/sterile distiled water 1:1, Injection 2: 5% test substance, Injection 3: FCA with 10 % (w/w) test substance, 1:1
Induction dermal: 0,5 g sodium lauryl sulphate in 10 % petrolatum for 24 hours, followed by 0,4 ml 100% test substance for 24 hours
- Control group:
Induction intradermal: Injection 1: FCA/sterile distiled water 1:1, Injection 2: Peanut oil, Injection 3: FCA with peanutoil, 1:1
Induction dermal: 0,5 g sodium lauryl sulphate in 10 % petrolatum for 24 hours, followed by 0,4 ml peanut oil for 24 hours
- Site: Scapular region
- Frequency of applications: 1 intradermal, 1 dermal
- Duration: Day 0 to day 8 after injections, dermal induction duration: 48 hours
- Concentrations:-
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21 after injections
- Exposure period: 24 hours
- Test groups: 0,1 ml of test substance
- Control group: 0,1 ml of test substance
- Site: Both flanks, test substance on left flank , only peanut oil on right flank
- Concentrations: 100 % (w/w)
- Evaluation (hr after challenge): 24 hours and 48 hours after last exposure
OTHER: - Challenge controls:
- Challenge control group used 20 females, dose as test group
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Intradermal induction concentration: 5 % (w/w), Dermal Induction concentration 100 % (w/w), Challenge concentration 100 % (w/w)
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Intradermal induction concentration: 5 % (w/w), Dermal Induction concentration 100 % (w/w), Challenge concentration 100 % (w/w). No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Intradermal induction concentration: 5 % (w/w), Dermal Induction concentration 100 % (w/w), Challenge concentration 100 % (w/w)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Intradermal induction concentration: 5 % (w/w), Dermal Induction concentration 100 % (w/w), Challenge concentration 100 % (w/w). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Intradermal induction concentration: only peanut oil, Dermal Induction concentration: only peanut oil, Challenge concentration 100 % (w/w)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Intradermal induction concentration: only peanut oil, Dermal Induction concentration: only peanut oil, Challenge concentration 100 % (w/w). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Intradermal induction concentration: only peanut oil, Dermal Induction concentration: only peanut oil, Challenge concentration 100 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: Intradermal induction concentration: only peanut oil, Dermal Induction concentration: only peanut oil, Challenge concentration 100 % (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under these experimental conditions the test substance MPEM sensitized one out of twenty guinea pigs. According to the Kligmann (1966) classification scheme, MPEM can be classified as a weak sensitizer in guinea pigs. Furthermore, this result does not lead to classification as a sensitizer according to either Regulation (EC) No 1272/2008 or Dangerous Substances Directive (67/548/EEC).
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