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Administrative data

Description of key information

Based on a weight of evidence, the oral LD50 of polysulfides, di-tert-dodecyl is estimated to be higher than 2500 mg/kg bw. The dermal LD0 value for polysulfides, di-tert-dodecyl was > 2000 mg/kg bw (the highest dose tested).

Oral route

In a non-guideline dose range-finding toxicity study, male and female Sprague-Dawley rats (4/sex/dose were administered 0, 50, 250, 1250, or 2500 mg/kg bw/day of di-t-dodecyl polysulfides by daily gavage for seven days (Molinier, 1995). No mortality occurred during the treatment period. Ptyalism was observed in all males administered 1250 or 2500 mg/kg bw/day, and in 2/4 and 3/4 females administered 1250 and 2500 mg/kg bw/day, respectively. A slightly lower mean food consumption and body weight gain was observed in the males administered 2500 mg/kg/day. A thickened and/or translucent wall of the forestomach was noted for 3/4 females at 2500 mg/kg bw/day. There was no effect of treatment on organ weights.

In the range finding part of a micronucleus assay (Simar, 2010), 5 male and 5 female Sprague-Dawley rats were treated twice by oral gavage with a dose level of 2000 mg/kg of polysulfides, di-tert-dodecyl and observed for 24 hours after the last treatment. No mortality and clinical signs were observed.

An oral LD50 in rats of 20008 mg/kg was estimated using the Toxicity Estimation Software Tool (T.E.S.T) of the US EPA (2017).

In a pre-guideline study (Lauressergues, 1973), male Swiss mice (n=40) were dosed with polysulfides, di-tert-dodecyl. Mortality was observed over a 7-day period; clinical signs and body weight gain were not reported. The LD50was ca. 45.0 ml/kg bw.

Dermal route

In an OECD TG 402 study, Sprague-Dawley rats (n=20; male and female) were dermally exposed to polysulfides, di-tert-dodecyl (Guillot, 1986a). No mortality or behavioral abnormalities were noted following the initial administration of the test substance or during the 14 days following exposure. No cutaneous lesions were observed at the site of application or during the observation period. Body weight gain was not affected by the treatment, and no macroscopic abnormalities were observed in the animals sacrificed at the end of the observation period. The dermal LD0was > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Reason / purpose:
reference to other assay used for intermediate effect derivation
Qualifier:
no guideline available
Principles of method if other than guideline:
7-day range finding study.
GLP compliance:
no
Test type:
other: 7-day range finding study
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
50, 250, 1250, 2500 mg/kg
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
Clinical signs and mortality were checked twice daily. Food comsumption and body weight were record ed twice a week.Sacrifice and pathology
A complete macroscopic examination was performed on all animals killed at the end of the study. Adrenals, heart, kidneys, liver, spleen, thymus and gonades were weighed on all animals.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the treatment period
Clinical signs:
Ptyalism was observed in all the males given 1250 or 2500 mg/kg/day and in 2/4 or 3/4 females given 1250 or 2500 mg/kg/day, respectively
Body weight:
A slightly lower mean food consumption and body weight gain was observed in the males given 2500mg/kg/d.
Gross pathology:
Thickened and/or translucent wall of forestomach was noted for 3/4 females given 2500 mg/kg/day.
No effect of treatment was observed on organ weights.
Interpretation of results:
GHS criteria not met
Executive summary:

In a non-guideline dose range-finding toxicity study, male and female Sprague-Dawley rats (4/sex/dose were administered 0, 50, 250, 1250, or 2500 mg/kg bw/day of di-t-dodecyl polysulfides by daily gavage for seven days. No mortality occurred during the treatment period. Ptyalism was observed in all males administered 1250 or 2500 mg/kg bw/day, and in 2/4 and 3/4 females administered 1250 and 2500 mg/kg bw/day, respectively. A slightly lower mean food consumption and body weight gain was observed in the males administered 2500 mg/kg/day. A thickened and/or translucent wall of the forestomach was noted for 3/4 females at 2500 mg/kg bw/day. There was no effect of treatment on organ weights.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
In the range finding part of the micronucleus assay, 5 male and 5 female rats were treated twice by oral gavage with a dose level of 2000 mg/kg and observed for 24 hours after the last treatment.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France origin, Saint-Germain-surl’Arbresle; FRANCE
- Age at study initiation: 5 to 10 weeks old
- Weight at study initiation: approximately 200 g
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: animals were housed in polypropylene cages measuring 42.5 x 26.6 x 15 cm, covered by a stainless steel netted lid, in which they will be placed in groups of 3 or 2
- Diet (ad libitum): 801175 RM1(P)DU IRR 9Kgy irradiated from Special Diets Services
(ENGLAND).
- Water (ad libitum): softened by reverse osmosis and filtered on 0.2 µm membrane
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 20 times per hour
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 24h after the 2nd treatment
- Necropsy of survivors performed: no
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and clinical signs over 24 h
Mortality:
No mortality was observed.
Clinical signs:
No clinical sign was observed
Body weight:
Not recorded
Gross pathology:
Not performed
Interpretation of results:
GHS criteria not met
Executive summary:

In the range finding part of a micronucleus assay, 5 male and 5 female Sprague-Dawley rats were treated twice by oral gavage with a dose level of 2000 mg/kg of di-t-dodecyl polysulfides (TPS 32) and observed for 24 hours after the last treatment.No mortality and clinical signs were observed.

Endpoint:
acute toxicity: oral
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Qualifier:
according to
Guideline:
other: REACH guidance. Chapter R.6: QSARs and grouping of chemicals
Version / remarks:
May 2008
Principles of method if other than guideline:
T.E.S.T allows you to estimate the value for oral rat LD50 (amount of chemical in mg/kg body weight that causes 50% of rats to die after oral ingestion)
Specific details on test material used for the study:
Canonical SMILES: CC(C(C)(C)C)C(C)(C)C(C)(C)SSSC(C)(C)C(C)(C)C(C)C(C)(C)C
Species:
rat
Route of administration:
oral: unspecified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
20 008 mg/kg bw
Interpretation of results:
GHS criteria not met
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Pre-guideline study, poorly documented
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 5-10 male mice were treated by oral gavage with a dose level of 12.5, 25, 30, 40 and 50 ml/kg. The mortality was observed on a 7-day period. Clinical signs and body weight gain were not reported.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
Swiss
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage de Saint Denis de Pile (33), France
- Age at study initiation: no data
- Weight at study initiation: 22 +/-2 g
- Fasting period before study: 16 h
- Housing: 5/cage
- Diet (ad libitum): UAR, France
- Water (ad libitum): tap water
- Acclimation period:no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Route of administration:
oral: gavage
Vehicle:
other: undiluted
Doses:
12.5, 25, 30, 40 and 50 ml/kg
No. of animals per sex per dose:
5 or 10
Details on study design:
The mortality was observed on a 7-day period. Clinical signs and body weight gain were not reported.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 45 mL/kg bw
Based on:
test mat.
Mortality:
Dose (ml/kg) Mortality
12.5 0/5
25 2/5
30 3/10
40 4/10
50 10/10
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met
Executive summary:

In a pre-guideline study, male Swiss mice (n=40) were dosed with di-t-dodecyl polysulfide. Mortality was observed over a 7-day period; clinical signs and body weight gain were not reported. The LD50 was ca. 45.0 ml/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA-CREDO, France
- Age at study initiation: 5-7 weeks old
- Mean weight at study initiation: 189-192g for males and 164-166g for females
- Housing: individual housing in stainless steel mesh cages
- Diet (ad libitum): Rat pelleted complete maintenance (UAR, France)
- Water (ad libitum): softened and filtered drinking water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: wide aghesive and perforated tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
other: yes, distillated water
Details on study design:
- Duration of observation period following administration: 14 days
- Clinical signs ans skin reactions: 15 min after administration, then 1, 2 and 4 hours and daily for 14 days
- Body weight: day -1, 1, 8 and 15
- Necropsy of survivors performed: yes
Statistics:
Not appropriate
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
No mortality and no behavioral anomalies were noted following the administration of the product and during the 14 following days. The local tolerance of the product was good: no cutaneous lesions (erythema or oedema) were observed at the site of product application or during the observation period
Body weight:
The body weight gain of the treated animals was not affected by the treatment.
Gross pathology:
No macroscopic abnormality was observed in the animals sacrificed at the end of the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD0 of TPS 32 is higher than 2000 mg/kg.
Executive summary:

In an OECD TG 402 study, Sprague-Dawley rats (n=20; male and female) were dermally exposed to di-t-dodecyl polysulfides (TPS 32). No mortality or behavioral abnormalities were noted following the initial administration of the test substance or during the 14 days following exposure. No cutaneous lesions were observed at the site of application or during the observation period. Body weight gain was not affected by the treatment, and no macroscopic abnormalities were observed in the animals sacrificed at the end of the observation period. The dermal LD0was > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

According to the available data and criteria of regulation no. 1272/2008, no classification is warranted for oral, dermal and inhalation toxicity.