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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

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.