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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The irritant/corrosive potential of Lactofen was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; for reasons of animal welfare a sequential testing strategy was followed.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
other: shorn
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Other effects:
no effects reported

Lactofen is not an irritant to the skin. There were no systemic intolerance reactions.

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

The irritant/corrosive potential of Lactofen was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; for reasons of animal welfare a sequential testing strategy was followed.

The degree of erythema/eschar formation and oedema formation was recorded as specified by DRAIZE and any serious lesions or toxic effects other than dermal irritation were also recorded and described.

The mean erythema score after 24, 48, and 72 hours was 0.2 and the edema score = 0.

Therefore Lactofen is not an irritant to the skin. There were no systemic intolerance reactions.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The irritant/corrosive effects of Lactofen were tested on the eye of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No.405 -"Acute Eye Irritation/Corrosion"; for reasons of animal welfare a sequential testing strategy was followed.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Other effects:
no other effects reported

Lactofen is not irritating to eyes. There were no systemic intolerance reactions.

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

The irritant/corrosive effects of Lactofen were tested on the eye of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No.405 -"Acute Eye Irritation/Corrosion"; for reasons of animal welfare a sequential testing strategy was followed.

Eye irritations were scored and recorded approximately at 1, 24, 48 and 72 hours post application.

The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.

The mean cormeal opacity score after 24, 48, and 72 hours was 0, the iris score = 0, the redness conjunctivae score = 0.3 and the chemosis conjunctivae score = 0.

Therefore Lactofen is not irritating to eyes. There were no systemic intolerance reactions.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Lactofen is not irritating to the skin in different in vivo and in vitro stuides, including a recent study conducted according to OECD TG 404.

Lactofen is not irritating to eyes including a recent study conducted according to OECD TG 405.

In an acute toxicity inhalation study some local effects were observed, but only at high concentrations (5300 mg/m3). 10 rats (5 males and 5 females) were exposed for a period of 4 hours, to an atmosphere containing a respirable aerosol (5.30 mg/l) of the test substance. Four of the test animals died during the study. Irregular breathing, damp fur, crusty muzzle, alopcia, salivation, crusty eye, yellow/brown stained fur, nasal discharge, squinting, and poor coat quality were observed among the test animals. No reactions were observed in the control animals during the study. Necropsies revealed no gross lesions in 4 test and 8 control animals. Abnormalities of the lung, small intestine, stomach, external surface, and kidney were observed in the remaining test rats. Under the conditions tested, the LC50 was > 5.30 mg/l; which was the highest attainable aerosol concentration.

Justification for classification or non-classification

Lactofen is not irritating to the skin or eye in recent guideline complient studies. Effects indicative of some irritation after inhalation were reported in an acute inhalation study only at the highest attainable aerosol concentration 5300 mg/m3.