Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
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
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
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.