Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation, other
Remarks:
Experience with the chemical class of the substance and from observations of workers.
Type of information:
other: Experience with the chemical class of the substance and from observations of workers.
Adequacy of study:
other information
Study period:
2018
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Experience with the chemical class of the substance and from observations of workers.

Data source

Reference
Reference Type:
other: Experience at the registrant
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Experience with the chemical class of the substance and from observations of workers.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: 7-AMCA
Chemical name: 7-Amino-3-methoxy-cefalosporanic acid
Molecular formula: C9H12N2O4S
CAS No.: 24701-69-7
Supplier: Sponsor
Batch No.: 36423006
Certificate of analysis: Available
Purity: 90.1 % on anhydrous basis (HPLC)
Water content: 0.3 %
Solubility: In water 0.1 g/L at 20 °C
In methanol 0.05 g/L
Appearance: Yellowish powder
Conditions of storage: Refrigerator, in the dark. Protected from moisture
Stability: Stable over ca. 6 months under conditions of storage. Stable over several weeks at room temperature
Date of expiry: October 2000

Test animals

Species:
other: Humans

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
Category 1 (respiratory sensitising) based on GHS criteria
Conclusions:
Experience with the chemical class of the substance and from observations of workers advises to classify the substance as Resp.Sens. 1.
Executive summary:

Experience with the chemical class of the substance and from observations of workers advises to classify the substance as Resp.Sens. 1.