Registration Dossier
Registration Dossier
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EC number: 234-390-0 | CAS number: 11138-47-9
Respiratory sensitisation
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:
- 2 007
- Bibliographic source:
- European Commission, Joint Research Centre
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- 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
- Reference substance name:
- Sodium perborate tetrahydrate
- IUPAC Name:
- Sodium perborate tetrahydrate
- Details on test material:
- no further data
Constituent 1
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.
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