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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Polysulfides, di-tert-dodecyl
EC Number:
270-335-7
EC Name:
Polysulfides, di-tert-dodecyl
Cas Number:
68425-15-0
Molecular formula:
C24H58S15
IUPAC Name:
di (alkyl C11-C13 Branched, C12 Rich), polysulfure S3-S5 rich
Details on test material:
- Name of test material (as cited in study report): Di-tertio-dodecyl polysulfide (TPS 32)
- Physical state: yellow liquid
- Analytical purity: considered at 100%
- Sulfur content: 29.78%
- Lot/batch No.: 24-fev-2008

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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

Administration / exposure

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

Results and discussion

Effect levels
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 or clinical signs over 24 h
Mortality:
No mortality was observed.
Clinical signs:
other: other: No clinical sign was observed
Gross pathology:
Not performed

Applicant's summary and conclusion

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 or clinical signs were observed.