5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1-nonanol

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

For read across justification see Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris (2-ethylhexyl)trimellitate

IUPAC Name:

Tris (2-ethylhexyl)trimellitate

Details on test material:

- Name of test material (as cited in study report): Nuoplaz 6959 (Tris (2-ethylhexyl)trimellitate)
- Molecular formula (if other than submission substance): C33 H54 O6
- Molecular weight (if other than submission substance): 546.79
- Smiles notation (if other than submission substance): c1(c(ccc(c1)C(OC[C@@H](CCCC)CC)=O)C(OC[C@@H](CCCC)CC)=O)C(OC [C@@H](CCCC)CC)=O
- InChl (if other than submission substance): 1S/C33H54O6/c1-7-13-16-25(10-4)22-37-31(34)28-19-20-29(32(35)38-23-26 (11-5)17-14-8-2)30(21-28)33(36)39-24-27(12-6)18-15-9-3/h19-21,25-27H,7-18,22- 24H2,1-6H3
- Structural formula attached as image file (if other than submission substance): see 3319-31-1 structure.png

- Physical state: liquid
- Analytical purity: 98.95%
- Impurities (identity and concentrations): 2-ethylhexanol 0.05%, miscellaneous esters 1.00%
- Composition of test material, percentage of components: Tris (2-ethylhexyl)trimellitate, 2-ethylhexanol 0.05%, miscellaneous esters 1.00%
- Lot/batch No.: 39049

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage Michigan USA
- Age at study initiation: No data
- Weight at study initiation: 210-275 g
- Fasting period before study: No data
- Housing: A 0.5 m3 stainless steel inhalation chamber (Young & Bertke Cincinnati Ohio) during exposure period
- Diet (e.g. ad libitum): yes, Zeigler NIH07 open block formula (Gardners Pennsylvania USA)
- Water (e.g. ad libitum): yes, via water bottles
- Acclimation period: 8d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72+/-3 degrees F
- Humidity (%): 40+/- 10%
- Air changes (per hr): 10-20 during exposure period
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: December 2 1981 To: December 24 1981

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A 0.5 m3 stainless steel inhalation chamber (Young & Bertke Cincinnati Ohio)
- Exposure chamber volume: 0.5m3
- Method of holding animals in test chamber: No data
- Source and rate of air: No data
- Method of conditioning air: No data
- System of generating particulates/aerosols: Jet Nebuliser (Rhema Co. West Germany)
- Method of particle size determination: No data
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: 2+/-3 degrees F; 40+/- 10%; 0.1-0.2 in. H20 (using a Magnehelix gauge)
TEST ATMOSPHERE
- Brief description of analytical method used: filter paper/gravimetric technique; samples taken approximately every 30 mins during 4h exposure period
- Samples taken from breathing zone: yes/no: No data

VEHICLE
- Composition of vehicle (if applicable): N/A
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: No data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): No data

CLASS METHOD (if applicable): N/A
- Rationale for the selection of the starting concentration: No data

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

Estimated concentration: 2,600 mg/m3
Actual concentration: 2, 588.6 mg/m3 by gravimetric measurement

No. of animals per sex per dose:

5 males & 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?): 14d
- Frequency of observations and weighing: mortality & clinical signs daily, body weights: pre-exposure & weekly thereafter
- Necropsy of survivors performed: yes/no: yes on d15
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: clinical signs, body weights & macroscopic observation at necropsy.

Statistics:

N/A limit test; means and SDs calculated

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 600 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: single dose concentration

Mortality:

None

Clinical signs:

other:

Body weight:

With respect to body weights pre exposure, body weight increased on days 7 & 14 of the observation period.

Gross pathology:

At necropsy on d15, 5/5 males & 3/5 females had reddened patches on the lung.

Other findings:

No data

Any other information on results incl. tables

Mean (SD) Body weights (g) of 5 male & 5 female rats exposed to 2600 mg/m³TOTM

Intervals	Males	Females
Pre-exposure	265.1 ± 8.40	213.9 ± 2.66
Day 7	297.8 ± 14.02	223.2 ± 3.96
Day 14	329.7 ± 15.27	238.1 ± 4.82

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The authors concluded that under the conditions of this experiment 2,600 mg/m3 Nuoplaz 6959/Tris (2-ethylhexyl)trimellitate had little or no effect on the rat after a 4h exposure.

Executive summary:

The acute 4 hour inhalation toxicity (LC50) in the rat is in excess of 2600 mg/m3