2-Hydroxypropyl-β-cyclodextrine ethers

Acute Toxicity: inhalation

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

12 May, 1981

GLP compliance:

yes

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Wiga, Sulzfeld, FRG
- Age at study initiation: 7 weeks
- Weight at study initiation: the mean body weights of the male and female rats were 197 g and 168 g
- Fasting period before study:
- Housing: 5 by sex per cage
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5- 25°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

<=

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: modified nose-only inhalation chamber from ADG Developments LTD., Codicote, Hitchin, Herts.SG4 8UB, United Kingdom.
- Exposure chamber volume: ca. 50 L

- airflow: 8.3 m3/h
- System of generating particulates/aerosols: Jetmill
- Temperature, humidity in air chamber: The temperature was 20°C, relative humidity was 18 %.

TEST ATMOSPHERE
- Brief description of analytical method used: Representative samples were obtained by passing 10 1 test atmosphere at ca. 5 l/min through fiber glass filters (Sartorius). Before and after sampling each filter was weighed. The actual concentration was calculated by dividing the weight difference before and after sampling by the amount of air sampled.
- Samples taken from breathing zone: no

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Particle size measurement showed that ca. 83 % of the particles had an aerodynamic diameter equal to or smaller than 4.2 µm.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

The mean actual concentration (and its standard deviation) was 2.95 (0.84) g/m3 Thefluctuations in the concentration were quite large. The nominal concentration was 5.9 g/m3

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were visually inspected just before exposure, for reactions to treatment during the exposure, shortly after exposure, and at least oncedaily during the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.95 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

Male: 2.95 mg/L; Number of animals: 5; Number of deaths: 0
Female: 2.95 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Shortly after exposure: slight red nasal discharge and soft faeces in all females. Partially closed eyes in 2/5 males and 1/5 females. 7/10 animales had loss of hair in the 2nd week p.a.

Body weight:

No abnormalities in body weight gain were observed, except for a slight weight gain in female no. 7 during the first week of observation.

Gross pathology:

Lung weights were considered to be in a normal range for rats of this strain and age.
Autopsy of the rats revealed no abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a limit study in Wistar rats according to OECD 403 no mortality or relevant clinical effects were observed at reasonably maximal attainable concentration of 2.95 mg/L.