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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
Study period:
1982-08-03, 1982-08-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-study, but without GLP

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