Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
EC Number:
413-750-2
EC Name:
A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
IUPAC Name:
413-750-2
Constituent 2
Reference substance name:
reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
IUPAC Name:
reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
Test material form:
not specified

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Methylcellulose 400 cps water solution
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
- Male: 5
- Female: 5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified
Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
- Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Piloerection was observed only two hours after test article administration in two male and three female rats.
Gross pathology:
Effects on organs: At the gross pathology examination carried out at the end of the observation period no changes were noted in all necropsied
animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LD50 (rat) > 5000 mg/kg bw
The test substance, when administered by oral route to rat, under the conditions adopted in this study, did not cause overt signs of toxicity.
Executive summary:

The acute oral toxicity of the structural analogue has been determined in a GLP test with rats according to EU method B.1 in a limit test. The LD50 value was > 5000 mg/kg bw, the test substance showed no toxicity under the conditions of the test.

Since EC 700-397-7 is a near analogue to the test substance (EC 413-750-2), the experimental data from this substance were used in a read-across approach.