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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry, permission to refer granted by ECHA
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Magnusson's Maximization test
Species:
guinea pig
Strain:
Dunkin-Hartley
Concentration / amount:
Concentration of test material and vehicle used at induction:
2.75% and 5.5% in water (intradermal injection)
Concentration of test material and vehicle used for each challenge:
5.5% in water (patch application)
Concentration / amount:
Concentration of test material and vehicle used at induction:
2.75% and 5.5% in water (intradermal injection)
Concentration of test material and vehicle used for each challenge:
5.5% in water (patch application)
No. of animals per dose:
Number of animals in test group: 10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 5.5 % Evidence of sensitisation of each challenge concentration: No positive reactions. Other observations: In the preliminary test the concentration of 5.5% appears non irritant for both topical and intradermal routes.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Maximum concentration not causing irritating effects in preliminary test: 5.5 %
Evidence of sensitisation of each challenge concentration: No positive reactions.
Other observations: In the preliminary test the concentration of 5.5% appears non irritant for both topical and intradermal routes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the Maximization test performed with guinea pigs, no sensitization potential was observed for Phenethylammonium salt of fosfomycin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the results of the Maximization test and according to Regulation (EC) n. 1272/2008, the substance is not classified for its sensitizaion potential.