Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, isotridecyl ester

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

other: no data

Limit test:

yes

Test material

Test material information

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

Details on test material:

Physical form of substance: L
Mass median aerodynamic diameter (for liquid and solid aerosol): Particle size determination indicated 94.0% and 93.9% of the test aerosol particles to be <3.5µm for groups 1 and 2 respectively

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

nose/head only

Vehicle:

not specified

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

The nominal concentrations administered were 87.85 mg/L (group 1) and 70.14mg/L (group 2).

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:

LC50

Effect level:

> 7.5 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

- Male: 4.07 mg/L; Number of animals: 5; Number of deaths: 0
- Male: 7.53 mg/L; Number of animals: 5; Number of deaths: 0
- Female: 4.07 mg/L; Number of animals: 5; Number of deaths: 0
- Female: 7.53 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: An unkempt appearance was noted for all Group 1 animals immediately post dose and one animal of Group 2 appeared subdued and showed hunched posture over the first 24h post dose. Otherwise no other abnormalities w

Body weight:

There was no effect on body weight profile following exposure to the test substance.

Gross pathology:

Necropsy examination:
All Group 1 animals were seen to have no abnormalities.
Slightly mottled lungs in all but 2 Group 2 animals and pale/discoloured lungs were noted in one Group 2 male and 1 Group 2 female. These were
deemed to be in accordance with normal background findings in acute rat studies at IRI and not attributable to treatment.

Body weight ratio:
Lung:body weight ratios were generally within normal limits for all animals, although Group 2 males tended towards the bottom of the expected
range.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Eu GHS

Conclusions:

LC50 (rat) > 7.5 mg/L air (4h)
The test substance did not produce any evidence of toxicity in Sprague-Dawley rats following exposure for 4 h to an atmosphere containing 7.53 mg/L air (measured gravimetrically).

Executive summary:

The acute inhalation toxicity of the structural analogue has been determined in a GLP test with rats according to OECD Guideline No. 403. The test substance did not produce any evidence of toxicity in Sprague-Dawley rats following exposure for 4 h to an atmosphere containing 7.53 mg/L air (measured gravimetrically), so the LC50 value is > 7.5 mg/L air (4h).

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.