Strontium neodecanoate

Specific investigations: other studies

Link to relevant study record(s)

Reference

Endpoint:

specific investigations: other studies

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles - GLP

Qualifier:

no guideline followed

Principles of method if other than guideline:

Alarie method

GLP compliance:

yes

Type of method:

in vivo

Endpoint addressed:

respiratory irritation

Species:

mouse

Strain:

Swiss Webster

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 23-26 g
- Housing: double housed
- Diet (e.g. ad libitum): Purina rodent chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 54-78
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

inhalation: aerosol

Vehicle:

unchanged (no vehicle)

Details on exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 4 l chamber
- Method of holding animals in test chamber: body-only plethysmographs
- System of generating particulates/aerosols: atomizer
- Air flow rate: 35 lpm

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

30 minutes

Frequency of treatment:

Single

Post exposure period:

5-10 minutes of room air

Remarks:

Doses / Concentrations:
3607, 1098, or 334 mg/m3
Basis:
other: average actual concentration

No. of animals per sex per dose:

4

Examinations:

- Gross ocular examinations
- Respiratory rate

Details on results:

Mice received 30 minute head only exposures to average actual concentrations of 3607 (group 1), 1098 (group 2), or 334 (group 3) mg/m3. The group 1 mean respiratory rate was depressed 42.5% below the pre-exposure rates, while the group 2 rate was decreased 24.9 %. The group 3 sample respiratory rate was increased by 7.9%. One of the group 1 mice died approximately 16 minutes after the start of the exposure. The three surviving mice displayed both sensory and pulmonary responses. The RD50 based on the three exposure groups is 5491 mg/m3, although all of the groups mean decreases were less than 50%.

Conclusions:

The RD50 is estimated at 5491 mg/m3.

Executive summary:

In this study, mice received 30 minute head only exposures to average actual concentrations of 3607 (group 1), 1098 (group 2), or 334 (group 3) mg/m3 of neodecanoic acid to determine the respiratory irritation potential.  The group 1 mean respiratory rate was depressed 42.5% below the pre-exposure rates, while the group 2 rate was decreased 24.9 %.  The group 3 sample respiratory rate was increased by 7.9%.  One of the group 1 mice died approximately 16 minutes after the start of the exposure.  The three surviving mice displayed both sensory and pulmonary responses.  The RD50 based on the three exposure groups is 5491 mg/m3, although all of the groups mean decreases were less than 50%. 

Description of key information

Neodecanoic acid is not an irritant to the upper (sensory) portion of the respiratory system.

Additional information

In a study to assess respiratory irritation, mice received 30 minute head only exposures to average actual concentrations of 3607 (group 1), 1098 (group 2), or 334 (group 3) mg/m3 of neodecanoic acid. The group 1 mean respiratory rate was depressed 42.5% below the pre-exposure rates, while the group 2 rate was decreased 24.9 %. The group 3 sample respiratory rate was increased by 7.9%. One of the group 1 mice died approximately 16 minutes after the start of the exposure. The three surviving mice displayed both sensory and pulmonary responses. The RD50 based on the three exposure groups is 5491 mg/m3, although all of the groups mean decreases were less than 50%.