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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: inhalation

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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

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.