Ethylene bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Dec 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study design equivalent to OECD Guideline 401 with minor deviation and sufficient reporting.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only females tested

GLP compliance:

no

Remarks:

performed before GLP guidelines

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

DTB-Glycolester

IUPAC Name:

DTB-Glycolester

Constituent 2

Reference substance name:

Bis[3.3-bis(4'-hydroxy-3-tertiarybutylphenyl)-butanoic acid]-glycolester

IUPAC Name:

Bis[3.3-bis(4'-hydroxy-3-tertiarybutylphenyl)-butanoic acid]-glycolester

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

white powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst bred
- Weight at study initiation: 90 - 104 g
- Fasting period before study: 16 h before administration
- Housing: in plastic cages on a bedding of wood shavings
- Diet (e.g. ad libitum): Altromin 1324 (Atlrogge, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- concentration in vehicle: 25 % (w/v)

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
No food was given to he rats for 16 h before administration. Food was given to the animals again 2 h after administration of the product. The period of observation after administration amounted to 14 days. During this period the animals were weighed weekly.
At the end of the subsequent observation period the animals were sacrificed and subjected to macroscopic evaluation.

Statistics:

None

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Remarks on result:

other: no effects

Mortality:

no mortality observed

Clinical signs:

other: The behavior of the animals was normal both after administration and during the subsequent follow-up period.

Gross pathology:

Dissection of the sacrificed animals yielded no significant macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of Hostanox O 3 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study Hostanox O 3 is not subject for labelling and classification requirements according to regulatory requirements.

Executive summary:

Hostanox O 3 was tested for its acute oral toxicity potential. 10 female rats were treated with 15000 mg/kg bw and observed for 14 days. No deaths or clinical signs were recorded.

The median lethal dose of Hostanox O 3 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study Hostanox O 3 is not subject for labelling and classification requirements according to regulatory requirements.