Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1983-09-27, 1983-10-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Upon an acute intraperitoneal administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined.
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
EC Number:
229-722-6
EC Name:
Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
Cas Number:
6683-19-8
Molecular formula:
C73H108O12
IUPAC Name:
3-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}-2,2-bis({[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}methyl)propyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
Details on test material:
- 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, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 184 - 243 g
- Fasting period before study: Yes, overnight
- Housing: groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): Ad libitum, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum):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:
intraperitoneal
Vehicle:
arachis oil
Doses:
1000 mg/kg
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, a.m. and p.m. on working days; body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
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:
> 1 000 mg/kg bw
Remarks on result:
other: Nominal
Mortality:
None
Clinical signs:
Dyspnoea, exophthalmus, ruffled fur and curved body position (Table 1).
Body weight:
Table 2
Gross pathology:
Peritoneal adhesions or pseudomembranes around the spleen, were found in all animals. In addition one female had adhesions around the kidneys.

Any other information on results incl. tables

Table 1: Signs and symptoms*

Dose: 1000 mg/kg
Observations Exposure day (h) Post-exposure period (D)
1 2 3 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Dyspnoea xx xx xx xx xx x x x x x x x











Exophothalmus x x x x x x x x x x















Ruffled fur xx xx xx xx xx x x x x x x













Curved body position x x x x x x x x x

















*) x = slight; xx = moderate; xxx = marked

Table 2. Body weights and standard deviation.

Dose mg/kg Males Females
day 1 day 7 day 14 day 1 day 7 day 14
1000 231±16 273±15.3 325±26.4 190±5.4 204±7.5 221±7.7

Applicant's summary and conclusion

Conclusions:
The test item has practically no acute toxicity when administered intraperitoneally to the albino rat.