Registration Dossier
Registration Dossier
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EC number: 222-671-0 | CAS number: 3570-55-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Mar 1992 - 02 Feb 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA was not yet validated at the time of the study.
Test material
- Reference substance name:
- 2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
- EC Number:
- 411-290-7
- EC Name:
- 2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
- Cas Number:
- 131538-00-6
- Molecular formula:
- C7 H16 S5
- IUPAC Name:
- 2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
Winkelmann, Borchen, Germany
- Weight at study initiation:
test group: 342.6 ± 19.63 g; vehicle controls: 342.3 ± 17.62 g
- Housing:
1 - 4 per cage, Makrolon Type IV
- Diet (e.g. ad libitum):
Altromin tpf 3022, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Quarantine: 6 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
21 ± 2 °C
- Humidity (%): 45 - 65%
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light):
12 / 12
- IN-LIFE DATES: From: 1992-08-04 To: 1992-09-24
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.2%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0%
- Day(s)/duration:
- Day 7, 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.005%
- Day(s)/duration:
- Day 21, 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 22
- Details on study design:
- RANGE FINDING TESTS:
Intradermal: 0.2%, 1%, 5%, 10% w/w in paraffin oil
Topical: 0.005%, 0.01%, 0.05%, 0.2%, 1%, 4%, 10%, 25% w/w in petrolatum - Challenge controls:
- 22 naive (sham-induced) animals
- Positive control substance(s):
- yes
- Remarks:
- DNCB, 0.1% (ethanol), 1.0% (petrolatum), 0.025% (petrolatum) for intradermal induction, topical induction, and challenge, respectively.
Results and discussion
- Positive control results:
- 22/22 of animals showed skin reactions
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.005%
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.005%
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.005%
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.005%
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.025%
- No. with + reactions:
- 22
- Total no. in group:
- 22
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.025%
- No. with + reactions:
- 22
- Total no. in group:
- 22
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the GPMT results, DMPT is not a skin sensitizer.
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