Registration Dossier
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EC number: 270-336-2 | CAS number: 68425-16-1
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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Endpoint summary
Administrative data
Description of key information
One key study in guinea pigs was identified to evaluate the skin sensitising potential of di-tert-nonyl polysulfide, which was conducted according to OECD TG 406 and in compliance with GLP. The study concluded the test material to be not sensitising to skin (Manciaux, 2002).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-12-28 to 2002-02-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 96/54/EC, B.6
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OECD GLP ENV/MC/CHEM(98)17; Commission Directive 1999/11/EC; Ministere de l'Economie, Des Finances et de l'Industrie
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the implementation of the REACH Regulation.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-sex: male and nulliparous and non-pregnant female guinea pigs.
-justification for species choice: species generally accepted by regulatory authorities for this type of study. The strain used has been shown to produce a satisfactory sensitization response using known sensitizers.
- source: Charles River Laboratories, Saint-Aubin-lès-Elbeuf, France.
- age: 1-3 months
- weight: 422 ± 17 g for the males and 414 ± 21 g for the females.
- acclimation: at least 5 days before the beginning of the study
- food: ad libitum, 106 pelleted diet
- water: ad libitum
ENVIRONMENTAL CONDITIONS
- housing: 48 cm x 27 cm x 20 cm
- temperature: 22 ± 2°C
- relative humidity: 30 to 70%
- light/dark cycle: 12 h/12 h
-ventilation: approximately 12 cycles/hour of filtered, non-recycled air - Route:
- intradermal and epicutaneous
- Vehicle:
- other: intrademal = corn oil; epicutaneous = acetone
- Concentration / amount:
- Induction (treated group)
Intradermal injections (day 1): TPS 37 LS at the concentration of 25% (w/w) in corn oil,
Topical application (day 8): TPS 37 LS at the concentration of 50% (w/w) in acetone.
Challenge (all groups)
Topical application (day 22): TPS 37 LS at the concentration of 1% (w/w) in acetone. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: intrademal = corn oil; epicutaneous = acetone
- Concentration / amount:
- Induction (treated group)
Intradermal injections (day 1): TPS 37 LS at the concentration of 25% (w/w) in corn oil,
Topical application (day 8): TPS 37 LS at the concentration of 50% (w/w) in acetone.
Challenge (all groups)
Topical application (day 22): TPS 37 LS at the concentration of 1% (w/w) in acetone. - No. of animals per dose:
- 5/sex for control; 10/sex for treated group
- Details on study design:
- 1st application: Induction 25 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 1 % occlusive epicutaneous - Challenge controls:
- left flank - vehicle only (acetone)
- Positive control substance(s):
- no
- Positive control results:
- no data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No cutaneous reactions were noted
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No cutaneous reactions were noted
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- no test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No cutaneous reactions were noted
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- no test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No cutaneous reactions were noted
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20 % (w/w)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Oedema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20 % (w/w)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Oedema
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the maximization method of Magnusson and Kligman, the test item TPS 37 LS at the concentration of 1% does not induce delayed contact hypersensitivity in guinea pigs.
- Executive summary:
In a skin sensitization test, male and female Hartley guinea pigs (10/sex) were exposed to di-tert-nonyl polysulfide (TPS 37 LS; CAS # 68425-16-1). On day 1 of the induction phase, all animals in the treatment group were administered the following 3 pairs of intradermal injections in the intrascapular region: (1) Freund’s complete adjuvant (FCA) 50% v/v in 0.9% NaCl; (2) TPS 37 LS (25% w/w in corn oil; and (3) TPS 37 LS (25% w/w in corn oil) in a 50% v/v mixture of FCA and 0.9% NaCl. Animals in the control group were administered corn oil using a dosing regimen identical to the one described above. On day 8 of the induction phase, animals in the treatment group were topically administered TPS 37 LS (at the same site) at a concentration of 50% (w/w) in acetone while animals in the control group were topically administered the vehicle control acetone. The application sites were subsequently covered with occlusive dressing for a period of 48 hours.On day 22, all animals of the test and control group were challenged by a cutaneous application of TPS 37 LS (1% w/w in acetone) to the right flank. The left flank served as control and received the vehicle only. Subsequently, the test material and vehicle control were maintained under an occlusive dressing for a period of 24 hours and skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.
No mortality or signs of adverse clinical toxicity were observed at challenge or through the study period. No positive reactions were noted for any of the test (0/20) or control animals (0/10) at 24 and 48 hours. Based on these results, TPS 37 LS was not found to be sensitising in the guinea pig maximisation test.
This study received a Klimisch Score of 1 and was classified as reliable without restriction because it is GLP compliant and follows OECD Guideline 406.
Reference
No clinical signs and no deaths related to treatment were noted during the study. No cutaneous reactions were observed after the challenge application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
One key study in guinea pigs was identified to evaluate the skin sensitising potential of di-tert-nonyl polysulfide.
In a key skin sensitization test (Manciaux, 2002; Klimisch score = 1), male and female Hartley guinea pigs (10/sex) were exposed to di-tert-nonyl polysulfide (TPS 37 LS; CAS # 68425-16-1). On day 1 of the induction phase, all animals in the treatment group were administered the following 3 pairs of intradermal injections in the intrascapular region: (1) Freund’s complete adjuvant (FCA) 50% v/v in 0.9% NaCl; (2) TPS 37 LS (25% w/w in corn oil; and (3) TPS 37 LS (25% w/w in corn oil) in a 50% v/v mixture of FCA and 0.9% NaCl. Animals in the control group were administered corn oil using a dosing regimen identical to the one described above. On day 8 of the induction phase, animals in the treatment group were topically administered TPS 37 LS (at the same site) at a concentration of 50% (w/w) in acetone while animals in the control group were topically administered the vehicle control acetone. The application sites were subsequently covered with occlusive dressing for a period of 48 hours. On day 22, all animals of the test and control group were challenged by a cutaneous application of TPS 37 LS (1% w/w in acetone) to the right flank. The left flank served as control and received the vehicle only. Subsequently, the test material and vehicle control were maintained under an occlusive dressing for a period of 24 hours and skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.
No mortality or signs of adverse clinical toxicity were observed at challenge or through the study period. No positive reactions were noted for any of the test (0/20) or control animals (0/10) at 24 and 48 hours. Based on these results, TPS 37 LS was not found to be sensitising in the guinea pig maximisation test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a dermal sensitisation study, di-tert-nonyl polysulfide was not observed to be a skin sensitiser in guinea pigs. Therefore, di-tert-nonyl polysulfide does not meet the criteria for classification as a dermal sensitiser under CLP Regulation (EC) No 1272/2008.
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