Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean score 1
Time point:
other: overall at 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: overall 24, 48, 72 h
Score:
0
Max. score:
0
Interpretation of results:
not classified
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3 males
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: overall at 24, 48, 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: overall at 24, 48, 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: overall at 24, 48, 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
Transient slight conjunctival redness (score 1) was seen at
the 1 hour observation in all treated animals. Transient
slight chemosis (score 1) was also noted only 1 hour after
the test article administration in 2 animals only.
Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
No clinical signs or behavioral alterations were noted in any treated rabbit.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance resulted not irritant to the skin and to the eyes in in vivo test systems.

Justification for classification or non-classification

According to Regulation (EC) n. 1272/2008, Phenethylammonium salt of fosfomycin is neither classified as irritant to the skin nor to the eyes.