Registration Dossier

Diss Factsheets

Administrative data

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: The test was not carried out under the conditions of GLP. The test procedure is in accordance with generally accepted scientific standard procedures and described in sufficient detail.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Principles of method if other than guideline:
According to Alarie (1981, Food and Cosmetic Toxicology 19, 623-625) and American Society for Testing and Materials E981-84
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
respiratory irritation

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
EC Number:
239-707-6
EC Name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
Cas Number:
15630-89-4
Molecular formula:
CH2O3.3/2H2O2.2Na
IUPAC Name:
tetrasodium tris(peroxol) dicarbonate
Details on test material:
- Name of test material (as cited in study report): Sodium carbonate peroxyhydrate
- Analytical purity: > 88 %
- Source: Solvay Interox SA

Test animals

Species:
mouse
Strain:
other: HSD/CPB:SE Swiss
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Austerlitz, The Netherlands
- Age at study initiation:
- Weight at study initiation: 23.5-28.6

Administration / exposure

Route of administration:
inhalation: dust
Vehicle:
unchanged (no vehicle)
Details on exposure:
The mass median aerodynamic diameter ranged from 5.0 to 7.2 um. The test material was fed from a reservoir with a motor driven helix to a strem of fresh air into an air mover. The concentration was measured during each exposure by gravimetrical analysis.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Gravimetrical analysis
Duration of treatment / exposure:
20 minutes
Frequency of treatment:
One treatment
Doses / concentrations
Remarks:
Doses / Concentrations:
309, 330, 354, 698, 764 and 805 mg/m³
Basis:
analytical conc.
No. of animals per sex per dose:
4 mice
Control animals:
no
Details on study design:
Respiratory rates and volumes were evaluated before, during and after exposure at intervals of 5 minutes. Observations of clinical symptoms were made between 1 and 4 hours and 1 day after exposure. At necropsy external appearance and macroscopic changes in the abdominal and thoracic cavities were evaluated and lungs and tracheas were removed and weighed.

Examinations

Examinations:
Respiratory rates and volumes were evaluated before, during and after exposure at intervals of 5 minutes. Observations of clinical symptoms were made between 1 and 4 hours and 1 day after exposure. At necropsy external appearance and macroscopic changes in the abdominal and thoracic cavities were evaluated and lungs and tracheas were removed and weighed.

Results and discussion

Details on results:
Only respiratory rates and consequently minute volumes were decreased due to exposure to the test material. The decrease in minute volumes is fully attributable to the decrease in respiratory rate since no effect on tidal volumes were observed. From these findings it is concluded that the test substance is a respiratory irritant with an RD50 value of approximately 0.7 g/m3, being the lowest test material concentration tested, at which almost a 50 % reduction of respiratory rate was observed. No clinical signs and effects on body weight, lung weight and macroscopy were observed.

Applicant's summary and conclusion

Conclusions:
The RD50 (reduction of respiratory rates by 50 %) of sodium percarbonate dusts determined in male mice is approximately 700 mg/m3.
Executive summary:

A test on the respiratory irritation of sodium percarbonate (purity >88 %) was performed with male HSD/CPB:SE Swiss mice (Janssen 2001). Four animals per test group were exposed nose-only to particles of the test material (mean particle diameter of 5.0 to 7.2 micrometre) for durations of 20 minutes at concentrations of 309, 330, 354, 698, 764 and 805 mg/m3, as determined by gravimetrical measurement. Due to the relatively large particle size it was expected that animals were exposed predominantly in the nose and the upper respiratory tract. Decreased respiratory rates and minute volumes were observed in all exposure groups. In the 309 mg/m³ exposure group the respiratory rate was only decreased at the end of the exposure period, but in the other groups the respiratory rate was decreased throughout the whole exposure period. No full recovery was observed in the 764 mg/m³ group during the post-exposure period (up to 1 day). No other clinical signs were observed, and there was no indication of a treatment related effect at necropsy. Lung weight was unaffected by treatment.

From the findings it was concluded that the test material caused respiratory irritation in test animals with an RD50 of approximately 700 mg/m³, which does not warrant classification in accordance with the CLP Regulation (EC) No 1272/2008.

Categories Display