3-[3-(pentanoyloxy)-2,2-bis[(pantanoyloxy)methyl]propoxyl]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl}propoxy)-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl}propyl 3,5,5-trimethylhexanoate

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 with acceptable restrictions. Lack of test material details.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

lack of test material details

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

68424-31-7

Cas Number:

68424-31-7

IUPAC Name:

68424-31-7

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Physical state: straw coloured liquid

Test animals

Species:

rat

Strain:

other: Alpk:APfSD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Alderly Park, Cheshire, UK
- Age at study initiation: 7 weeks

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: dried and filtered air with a nominal flow rate of 20 L/min
- System of generating aerosols: glass concentric jet atomiser
- Method of particle size determination: Marple Cascade Impactor

TEST ATMOSPHERE
- Brief description of analytical method used: a gravimetric method was used
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.51 µm/2.51 µm

CLASS METHOD
- Rationale for the selection of the starting concentration: a maximum concentration of 5 mg/L (OECD limit test) was selected for the target exposure level.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.0 mg/L (nominal concentration)
5.1 mg/L (analytical concentration)

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for gross clinical abnormalities during exposure and were checked daily thereafter. A detailed examination was conducted after exposure on Day 1 and on consecutive days, up to and including Day 15. Individual body weights were recorded on Day 1 and Days 2, 3, 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Immediately after exposure clinical signs were noticed, e.g. hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs were consistent with the use of restraint for exposure to the test atmosphere. Animals showed rap

Body weight:

No effect on body weight was noted.

Gross pathology:

Necropsy revealed no substance-related findings.

Other findings:

Lung weights were within normal limits in all animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified