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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Acute toxicity after single oral application was tested in female rats, which received 15,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 15,000 mg/kg bw) Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not have to be classified as acute orally toxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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


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
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw
Quality of whole database:
2 (reliable with restrictions)

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the results of two oral toxicity studies the LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw.


In accordance with REACH “Column 2” in Annex VIII there is sufficient weight of evidence from several independent sources of information leading to the conclusion that Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because
- the LD50value for acute oral toxicity of Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] is greater 15,000 mg/kg bw,
- Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] does not have to be classified as skin irritating,
- inhalation to consumer is very unlikely to occur, since the substance is embedded in polymeric matrices for consumer applications and
- occupational health surveillance did not report any reverse effect.
Therefore, it is concluded that testing of acute inhalation toxicity of Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] is not scientifically necessary.

It can reasonably be deduced that Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of a single oral dose of up to 15,000 mg/kg bw in female rats. Furthermore the substance does not have to be classified as skin irritating. Due to the combination of its molecular weight (795 g/mol) and the extent of the molecular structure it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 15,000 mg/kg bw/d) will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.

Justification for selection of acute toxicity – oral endpoint
Study design equivalent to OECD Guideline 401 with minor deviation and sufficient reporting.

Justification for selection of acute toxicity – inhalation endpoint
n.a.

Justification for selection of acute toxicity – dermal endpoint
n.a.

Justification for classification or non-classification

Due to the findings described in the acute oral toxicity study (LD50 oral in rats greater than 15,000 mg/kg bw) Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not have to be classified as acute orally toxic. Based on the substance's physico-chemical and non-irritant properties, as well as the unlikeliness of exposure no higher systemic exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the two oral toxicity studies. Therefore,Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not have to be classified as acute toxic.