Sodium surfactin

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 September 2001 to 17 October 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-240-8

EC Name:

-

Cas Number:

302933-83-1

Molecular formula:

C55-n H95.5-2n N7 013 Na1.5 (n-0-6) molecular weight: 1097-l4n (n=0-6)

IUPAC Name:

Sodium surfactin

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Lot No S1038
White powder

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
- Age at study initiation: 8 to 12 weeks
- females nulliparous and non-pregnant
- Weight at study initiation: 200 to 350
- Fasting period before study: None
- Housing: groups of 5 by sex in cages
- Diet (e.g. ad libitum): ad libitum except during exposure period
- Water (e.g. ad libitum): ad libitum except during exposure period
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 2°C
- Humidity (%): 55+/-15%
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

> 1.87 - < 2.02 µm

Geometric standard deviation (GSD):

> 2.71 - < 3.24

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical exposure chamber (ADG Developments)
- Exposure chamber volume: 30L
- Method of holding animals in test chamber:tapered polycarbonate restraining tube
- Source and rate of air: SAG 410 (TOPAS)
- Method of conditioning air: compressed air from oil free compressor and passed trhough water trap and respiratory filters
- System of generating particulates/aerosols: Test material was ground.
- Method of particle size determination: Marple Personal Cascade Impactor
- Temperature, humidity, pressure in air chamber: maesured every 30 minutes during exposure period

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetirc
- Samples taken from breathing zone: vacant port


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: a pre-exposure sighting of 1 mg/L

Analytical verification of test atmosphere concentrations:

no

Remarks:

Gravimetric

Duration of exposure:

4 h

Concentrations:

group 1, 0.49, group 2, 1.03 and group 3, 1.94 mg/L achieved

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: wiegjings at pre-exposure, 7 and 14 days or at death. Clinical signs at hourly intervals during exposure, immediately on removal from the restraaining tubes at end of exposure, one hour after termination of exposure and subsequently daily.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic abnormalities recorded and a detailed macroscopic examination for signs of irritancy or local toxicity of the respiratory tract

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1.42 mg/L air

Based on:

test mat.

95% CL:

> 1.25 - < 1.62

Exp. duration:

4 h

Mortality:

Group 3 (1.94 mg/L) 4/5 males and 4/5 females
Group 2 (1.03 mg/L) 1/5 males and 1/5 females
Group 1 (0.49 mg/L) 0/5 males and 0/5 females

Clinical signs:

other: Clinicl signs associated with restraint procedure were seen. Increased respiratory rates in all groups.

Body weight:

Body weight loss during week in males and 2 females showed a reduced bodyweight gain in week 1

Gross pathology:

No macroscopic abnormalities were noted amoungst survivingg animals at terminal kill. For animals that died on study abnormailities were detected in the lungs (haemorrhagic, fluid filled, abnormally red and dark patches).

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LC50 of 1.42 mg/L following a 4-hour exposure

Executive summary:

Groups of 10 (5 male/5 female) Sprague-Dawley rats were exposed to a dust atmosphere (nose only system) for 4 hours followed by a 14 -day observation period.

The acute inhalation median lethal concentrations (LC50) and 95% confidence limits were:

All animals : 1.42 (1.25 -1.62) mg/L

Males only : 1.42 (1.25 -1.62) mg/L

Females only : 1.42 (1.25 -1.62) mg/L

Group	Mean Achieved Atmosphere Concentration (mg/L)	MMAD (um)	Inhalabe Fraction (%<4 um)	Geometric Std Dev
3	1.94	1.91	73.7	3.19
2	1.03	2.01	75.3	2.71
1	0.49	1.87	74.0

Group	Mean Achieved Atmosphere Concentration (mg/L)	Male deaths	Female deaths	Total deaths
3	1.94	4/5	4/5	8/10
2	1.03	1/5	1/5	2/10
1	0.49	0/5	0/5	0/10