Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: solid
Details on test material:
Identification: AMIDE#71
Mass median aerodynamic diameter (for liq.+ solid aerosol): 2.8 µm

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
Mass median aerodynamic diameter of test substance: 2.8 µm
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
5.08 mg/L air
No. of animals per sex per dose:
5 males and 5 females at 5.08 mg/L
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Observations were made for mortality, signs of toxicity, and effects on organs at necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.08 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality at 5.08 mg/L air.
Male: 5.08 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.08 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Clinical signs during exposure consisted of a slightly decreased breathing rate in all animals that developed in severity from slight in the first hour to moderate during the remainder of the exposure period. In addition, slightly laboured breathing was noted in two male rats in the last two hours of exposure. Clinical signs shortly after exposure consisted of a decreased breathing rate, piloerection, hunched posture, blepharospasm and sluggishness, all to a moderate degree.

During the first day of the observation period sluggishness could still be seen in 3/5 males and in all females and ruffled fur was noted in 2/5 male and in all females. Less frequent findings on the first day consisted of solid fur, encrustations around eyes, nasal encrustations and grunting respiration. In the remainder of the 14-day observation period (day 2-14) no exposure-related observations were seen.
Gross pathology:
Effects on organs: Abnormalities at necropsy were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.
Executive summary:

The test substance was assessed for acute inhalation toxicity according to OECD 403. 

No mortality occurred at 5.08 mg/L air. Dose-related signs of toxicity included a slightly decreased breathing rate in all animals that developed in severity, from slight in the first hour, to moderate during the remainder of the exposure period. In addition, slightly laboured breathing was noted in two male rats in the last two hours of exposure. Clinical signs shortly after exposure included a decreased breathing rate and sluggishness. The sluggishness continued during the first day and some rats were observed to have grunting respiration. In the remainder of the 14-day observation period no exposure-related observations were seen. At necropsy, abnormalities were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.

The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.