tert-butyl peroxyneodecanoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

, number of treated animals, no necropsy was made for the survivng animals, additionally test animals and environmental conditions are not indicated

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl peroxyneodecanoate

EC Number:

247-955-1

EC Name:

tert-butyl peroxyneodecanoate

Cas Number:

26748-41-4

Molecular formula:

C14H28O3

IUPAC Name:

Reaction products of neodecanoic acid (or neodecanoyl chloride derived from neodecanoic acid) and tert-butyl hydroperoxide

Test animals

Species:

rat

Strain:

other: Charles River CD strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 216 to 266 gr.

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus and exposure chamber volume: each group of rats was placed in a sealed 59.1 L glass chamber and exposed to the appropriate level of test material for 4 hours

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

25, 50, 100, 200 mg/L

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

40.6 mg/L air

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LC50

Effect level:

64.8 mg/L air

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LC50

Effect level:

50 mg/L air

Based on:

test mat.

Effect levels 4

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

37.5 mg/L air

Based on:

act. ingr.

Remarks on result:

other: Calculated for 100 % of t-butyl peroxyneodecanoate.

Mortality:

At a concentration of 25 mg/L 2 animals out of 10 died
At a concentration of 50 mg/mL 5 animals out of 10 died
At a concentration of 100 mg/mL 8 animals out of 10 died
At a concentrtaion of 200 mg/mL 10 animals out of 10 died

Clinical signs:

other: Eye squint, lacrimation, ocular porphyrin discharge, nasal porphyrin discharge, decreased respiration, dyapnea, salivation, erythema, decreased activity - clinical signs observed during exposure. Cyanosis, eye squint, mydriasis, nasal porphyrin discharge,

Body weight:

Surviving male and female rats at 25.0 mg/L dose level and surviving female rats at 50.0 mg/L dose level exhibited normal body weight gains. Surviving male rats at the 50 mg/L and surviving female rats at dose level of 100 mg/L showed body weight losses during the 14 days observation period.

Gross pathology:

Necropsy findings in rats which died during the exposre/ observation time:
25 mg/L
lung congestion in 1 male and 1 female
hydrothorax, lung edema in 1 female
erosion, hypermia of stomach mucosa in 1 female
50 mg/L
bloody discharge, nose and mouth in 1 female
lung congestion in 2 males and 2 females
lung consolidation, abscesses, hemorrhage in 1 male
lung hemorrhage in 1 male and 1 female
liver congestion in 1 male
100 mg/L
no gross lesions in 3 males
bloody nasal discharge in 1 female
lung congestion in 2 females
lung hemorrhage in 1 male and 1 female
lung edema, hemorrhage in 1 male
200 mg/l
congestion, nasal mucosa, ears in 3 males
congestion nasal mucosa in 2 males
lung congestion, hemorrhage in 5 males and 5 females
dark red liver in 3 males and 2 females
dark red area, spleen in 1 male

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A LC50 value of 50 mg/L was determined in the study for t-butyl peroxyneodecacnoate (75 % in solvent). A LC50 value of 37.5 mg/L was calculated for 100 % t-butyl peroxyneodecacnoate.

Executive summary:

The test substance 75 % t-butyl peroxyneodecacnoate in mineral spirits was examined for its acute inhalation toxicity in a study similar to the OECD no. 403 study guideline. 20 males and 20 female albino rats of the Charles River CD strain were divided equally into 4 dosage group - 25, 50, 100, 200 mg/L. Mortality occurred in all dose groups, 2, 5, 8 and 10 animals out of 10 died at a dose concentration level of 25, 50, 100, 200 mg/L, respectively. Different clinical signs were observed in all dose groups and different necropsy findings were observed in surviving animals of all dose levels. A LC50 value of 50 mg/L was determined in the study for the test substance. A LC50 value of 37.5 mg/L was calculated for 100 % t-butyl peroxyneodecacnoate.