Bismuth oxide salicylate

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only one dose was tested.

Data source

Reference

Reference Type:

publication

Title:

Subacute inhalation toxicity of 109 industrial chemicals

Author:

Gage JC

Year:

1970

Bibliographic source:

Br J Ind Med 27:1-18

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl salicylate

EC Number:

204-317-7

EC Name:

Methyl salicylate

Cas Number:

119-36-8

IUPAC Name:

methyl salicylate

Details on test material:

- Name of test material (as cited in study report): Methyl salicylate
- Manufacturer: ICI, UK
No further details.

Test animals

Species:

rat

Strain:

other: Alderley Park

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Alderley Park
- Age at study initiation: No information
- Weight at study initiation: Mean 200g
- Fasting period before study: No information
- Housing: No information
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No information

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: No vehicle

Remarks on MMAD:

MMAD / GSD: Vapour therefore not applicable.

Details on inhalation exposure:

No information.

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

4 weeks

Frequency of treatment:

7 hours per day, 5 days per week

Doses / concentrations

Remarks:

Doses / Concentrations:
700 mg/m3
Basis:
nominal conc.

No. of animals per sex per dose:

4 females per dose

Control animals:

no

Details on study design:

No information.

Positive control:

None

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: Daily

FOOD CONSUMPTION:
- No data

FOOD EFFICIENCY:
- No data

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: No data

CLINICAL CHEMISTRY: No data

URINALYSIS: Yes
- Time schedule for collection of urine: Overnight after last exposure
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data

NEUROBEHAVIOURAL EXAMINATION: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Other examinations:

None

Statistics:

No information

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY
No toxic signs

ORGAN WEIGHTS
Organs normal

GROSS PATHOLOGY
Organs normal

HISTOPATHOLOGY: NON-NEOPLASTIC
Organs normal

Effect levels

Key result

Dose descriptor:

NOEC

Effect level:

700 mg/m³ air

Based on:

not specified

Sex:

female

Basis for effect level:

other: Methyl salicylate showed no evidence of toxicity by inhalation when tested at a concentration of 700 mg/m3

Target system / organ toxicity

Key result

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Methyl salicylate showed no evidence of toxicity by inhalation when tested at a concentration of 700 mg/m3 (effectively saturated) for 7 hours per day for four weeks.

Executive summary:

In this study (Gage, 1970), four female Alderley Park rats were exposed to a dynamic atmosphere (atmosphere continuously generated and passed through the exposure chamber) containing a 700 mg/m3 of methyl salicylate (effectively saturated) for 7 hours per day, 5 days per week for 4 weeks. Animals were weighed each day, and their condition and behaviour were recorded throughout the exposure period. Urine was collected overnight after the last exposure day for biochemical testing. Gross necropsy was conducted as well as microscopic examination of organs. Methyl salicylate at 700 mg/m3 did not cause any adverse effects.