Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary citation (data from peer-reviewed EU RAR)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
EU Risk Assessment Report Perboric acid, sodium salt. 3rd Priority List, Volume 71
Author:
ECB
Year:
2007
Bibliographic source:
European Commission, Joint Research Centre
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
10 guinea pigs were exposed to sodium perborate tetrahydrate at 1 hour intervals for a total of 4 hours to 9 mg/m3 or for 1 hour per week for 6 consecutive weeks to 11 mg/m3. 6 weeks after the first exposure both exposure groups were challenged with the same concentration as above for 1 hour.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Sodium perborate tetrahydrate
IUPAC Name:
Sodium perborate tetrahydrate
Details on test material:
no further data

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no further data

Test system

Route of induction exposure:
inhalation
Route of challenge exposure:
inhalation
Vehicle:
not specified
Concentration:
9 or 11 mg/m3
No. of animals per dose:
no further data
Details on study design:
10 guinea pigs were exposed to sodium perborate tetrahydrate at 1 hour intervals for a total of 4 hours to 9 mg/m3 or for 1 hour per week for 6 consecutive weeks to 11 mg/m3. 6 weeks after the first exposure both exposure groups were challenged with the same concentration as above for 1 hour.
Challenge controls:
no further data
Positive control substance(s):
none
Negative control substance(s):
none

Results and discussion

Results:
One guinea pig responded with retracted breathing. Skin tests, passive cutaneous anaphylaxis and agar gel diffusion test and histological evaluation of lung tissue did not reveal an effect in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
In this study there was no indication for a respiratory sensitizing potential of sodium perborate tetrahydrate.
Executive summary:

In a study with guinea pigs (inhalation exposure to sodium perborate tetrahydrate at 1 hour intervals for a total of 4 hours to 9 mg/m3 or for 1 hour per week for 6 consecutive weeks to 11 mg/m3; 6 weeks after the first exposure both exposure groups were challenged with the same concentration as above for 1 hour) there was no indication that the substance may cause respiratory sensitisation.