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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1982-08-03, 1982-08-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-study, but without GLP
Justification for type of information:
Thiobis Propanoic Acid Derivatives
The category covers thiiodipropionates that are symmetrically esterified by two linear aliphatic groups ranging in size from C10 to C24
The justification for the category is based on the expectation that the close structural similarity should result in properties that are either similar or follow a pattern that correlates with changes in the molecular weights of the compounds. The category members are high-molecular weight dithiopropionate esters that differ only in the chain length of the dialkyl ester functions and are expected to follow a regular pattern for all endpoints.
Based on the structures and molecularweights of the category members, as well as available data on category members, The predictive methods and extrapolation and interpolation of data within the category are acceptable. Data provided by other sources also demonstrate that these compounds generally have mammalian toxicities that are similar (e.g., acute oral LD 50, acute irritation thresholds, and genotoxicities) or follow a pattern that parallels changes in molecular weight (e.g., repeated-dose NOAEL).

The category is adequately supported based on chemical structure and available data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Didodecyl 3,3'-thiodipropionate
EC Number:
204-614-1
EC Name:
Didodecyl 3,3'-thiodipropionate
Cas Number:
123-28-4
Molecular formula:
C30H58O4S
IUPAC Name:
didodecyl 3,3'-sulfanediyldipropanoate
Details on test material:
- Name of test material (as cited in study report): IRGANOX PS 800
- Physical state: solid
- Stability under test conditions: stable

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 163 - 184 g
- Fasting period before study: overnight prior to dosing
- Housing: groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet: NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: CMPS80
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (mortality and symptoms); on days 1, 7, 14, and at death (weight)
- Necropsy of survivors performed: yes
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
None.
Clinical signs:
other: Dyspnoea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6. The animals recovered within 11 days.
Gross pathology:
No compound related gross organ changes were observed.

Any other information on results incl. tables

Table 1:Body Weights (g) and Standard Deviation

Dose (mg/kg bw)

Day 1

Day 7

Day 14

 

Males

5000

179 (4.6)

231 (7.9)

271 (8.4)

 

Females

5000

171 (7.4)

197 (7.9)

213 (12.1)

Applicant's summary and conclusion