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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
data not available
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: It is not clear whether the maximum attainable concentration was reached. No information on particle size distribution. No information on test substance purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
1-hrs inhalation toxicity test (6 animals, one dose level)
GLP compliance:
no
Test type:
other: 1-hrs inhalation toxicity test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 396g (mean body weight)
- Source, Age at study initiation, Fasting period before study, Housing, Diet, Water, Acclimation period: data not available


ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data nota available


IN-LIFE DATES: data not available

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus, Exposure chamber volume, Method of holding animals in test chamber, Source and rate of air, Method of conditioning air, System of generating particulates/aerosols, Method of particle size determination, Treatment of exhaust air, Temperature, humidity, pressure in air chamber: data not available


TEST ATMOSPHERE
- Brief description of analytical method used: data not available
- Samples taken from breathing zone: no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
0.9 mg/L
No. of animals per sex per dose:
6 male Albino rats were used
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were weighted at the beginning and at the termination of the study. Symptoms and mortality were observed after 0-15 min, 15-30 min, 30-45 min, 45-60 min, and then after 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11-14 days
- Necropsy of survivors performed: yes
Statistics:
data not available

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.9 mg/L air (analytical)
Exp. duration:
1 h
Remarks on result:
other: no mortality
Mortality:
No mortality was observed
Clinical signs:
other: The only signs observed were of irritation after 15-30 minutes: salivation, nasal discharge, lacrimation (one animal)
Body weight:
Mean terminal body weight was 425 g.
Gross pathology:
No significant findings were reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study, the test substance would not be not classified as toxic according to EU DSD criteria or in Acute toxicity categories 1-3 according to GHS UN/EU.
Executive summary:

The acute inhalation toxicity of salicylic acid was tested. Six male Albino rats were exposed for 1 hour to 0.9 mg/L of salicylic acid as a dust (measured concentration). They were then observed for 14 days.

Under the conditions of the test, the 1 -hr LC50 was greater than 0.9 mg/L (measured concentration). No mortality was observed and no significant findings were reported at necropsy. Clinical signs of irritation were restricted to salivation, nasal discharge, and lacrimation in one animal at 15 -30 minutes after exposure only.

Although the study has limitations in that the exposure duration was one rather than four hours, at a concentration lower than the standard limit dose, it was clear that there was no evident toxicity and minimal irritant effects.

No data were reported on particle size distribution, however data from typical production batches indicate that less than 5% of particles fall into the respirable range (MMAD <4um). Median MMAD is in the range 35 -50 um, with up to 20% non-inhalable particles > 100 um. The majority of inhaled particles are therefore impacted in the nasal region and transferred to the digestive tract.

It is considered that this study is adequate to fulfil this endpoint, which is a minor route of exposure for this substance.