Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 23, 1981 - December 3, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP, non-guideline study with limited details, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

EC Number:

228-985-4

EC Name:

Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Cas Number:

6386-38-5

Molecular formula:

C18H28O3

IUPAC Name:

methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Details on test material:

- Physical state: solid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba Geigy, Exp. Toxicology Sisseln
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 174 g (m) and 167 g (f)
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3), marked individually with picric acid.
- Diet: NAFAG No. 890, NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water containing 0.5% carboxymethylcellulose + 0.1% polysorbate 80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses:

5000 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: daily throughout the study
- Frequency of weighing: Body-weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

other: Dyspnoea (days 1 - 7), Exophthalmos (days 3 - 9), Ruffled fur (days 1 - 9) and curved Body position (days 1 - 7). All animals recovered after 10 days.

Gross pathology:

No compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The acute oral LD5O of the test substance in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg.

Executive summary:

In an oral acute toxicity study (pre-GLP) the test article was administered to 5 male and 5 female rats by oral gavage at a concentration of 5000 mg/kg. No mortalities occured. Clinical signs observed were dyspnoea, exophthalmos, ruffled fur and curved body position. All animals recovered within 10 days. At the end of the observation period all animals were submitted to a necropsy, no compound related gross organ changes were observed. Based on this result, the test substance is considered to be practically non toxic.