Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 603-087-9 | CAS number: 125700-67-6
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation
- Adequacy of study:
- supporting study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: reexposition test of a male human
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
- Principles of method if other than guideline:
- Nasal chellenge test with 1 mg/ml, Peak nasal inspiratory flow was measured.
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- TBTU in the study is reported as 2-(1H-benzotriazol-1-yl)-1,1,3,3-tetramethyluronium tetrafluoroborate with the structural formula for this substance, which is not equal to the substance identity of CAS: 125700-67-6 (with the correct CAS name 1H-Benzotriazolium, 1-[bis(dimethylamino)methylene]-, 3-oxide, tetrafluoroborate(1-)) of this registration.
no further details cited
Constituent 1
Test animals
- Species:
- human
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Six years of occupational exposure (since 1996), symptoms after 3 years of occupational exposure.
Test system
- Route of induction exposure:
- inhalation
- Route of challenge exposure:
- intranasal
- Vehicle:
- other:
- Concentration:
- 1 mg/ml
- No. of animals per dose:
- 10 control persons
- Details on study design:
- It is not quite clear whether PBS was used as vehicle for the nasal challenge test. The sensitized person was exposed to 1 mg TBTU/ml in the nasal challenge test.
Peak nasal inspiratory flow was measured. - Challenge controls:
- 10 persons served as control group
Results and discussion
- Results:
- A sensitized person was exposed to 1 mg TBTU/ml in a nasal chellenge test with 1 mg/ml.
Peak nasal inspiratory flow (PNIF) was measured. Reduction of 60% occured.
10 control persons had with the same challenge no reduction of PNIF. - Negative control results:
- 10 other persons
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Executive summary:
A single case of occupational contact uticaria, rhinoconjunctivitis, wheezing and dyspnea was observed after three years of occupational exposure to TBTU.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
