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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
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Magnusson's Maximization test
Test material information:
Composition 1
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 group
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 group
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.