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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:
September 1, 1982 - September 14, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
predating GLP, QAU statement included

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:
no
GLP compliance:
no
Remarks:
but QUA statement included in report
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
EC Number:
255-392-8
EC Name:
Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
Cas Number:
41484-35-9
Molecular formula:
C38H58O6S
IUPAC Name:
thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
Details on test material:
- Physical state: solid
- Analytical purity: > 99.5% (CIBA-GEIGY Ltd, Analyse Number: 5659, 25.10.1984)

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, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 183 - 202 g
- Fasting period before study: overnight
- Housing: groups of five in Macrolon cages type 3 with standardized soft wood bedding
- Diet: Rat food, NAFAG No. 890, ad libitum
- Water: ad libitum

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
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 or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations and weighing: Mortality: daily, a.m. and p.m. on working days; Signs and Symptoms: daily; Body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
Statistics:
From the body weights, the group means and their standard deviations were calculated.

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 occured
Mortality:
No deaths occured.
Clinical signs:
Following clinical signs were observed: dyspnoea: 1 hour after exposure until day 11, exophthalmus: 1 hour after exposure until day 12, ruffled fur: one hour after exposure until day 11, curved body position: one hour after exposure until day 4.
The animals recovered within 14 days.
Body weight:
Normal body weight gain.
Gross pathology:
No compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the oral LD50 in rats is greater than 5000 mg/kg.
Executive summary:

In a oral toxicity performed under GLP-like quality control and following OECD guideline 401, 5 male and 5 female rats (Tif:RAIf) were treated with the test substance by oral gavage administration at a dosage of 5000 mg/kg body weight. Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 served as vehicle. All animals were observed daily for 14 days for mortality, toxicity and clinical effects. Body weights were recorded on days 1, 7, 14 and at termination of the study. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. The following clinical signs were observed: dyspnoea: 1 hour after exposure until day 11, exophthalmus: 1 hour after exposure until day 12, ruffled fur: one hour after exposure until day 11, curved body position: one hour after exposure until day 4. The animals recovered within 14 days. No compound related gross organ changes were observed. Therefore, based on the results of this study, the LD50 in the rat was determined to exceed 5000 mg/kg body weight.

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