Fatty acids lanolin, di-, tri- and tetraesters with pentaerythritol and rape fatty acid

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Mar - 05 Apr 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. (Limited data on study substance)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Limited data on study substance

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

EC Number:

267-021-7

EC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Cas Number:

67762-52-1

IUPAC Name:

Dipentaerythritol Hexaesters of Pentanoic, Heptanoic and 3, 5, 5 Trimethylhexanoic acid

Test animals

Species:

rat

Strain:

other: Alpk:APfSD

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Not stated
- Source and rate of air: 20 L/min using a peristaltic pump
- Method of conditioning air: Clean dry air (dried and filtered, no further details)
- System of generating particulates/aerosols: Glass concentric jet atomiser
- Method of particle size determination: Marple Cascade Impactor

TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetrical measurement
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: No Data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.76 µm / 2.35 µm

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gravimetrically measurement of particulate concentrations

Duration of exposure:

4 h

Concentrations:

5 mg/L

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: on Days 1, 2, 3, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Clinical signs seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although, hunched posture and

Body weight:

No effect on body weight was noted.

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.