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Administrative data

Description of key information

not irritant to skin (500 mg) nor to eye (100 mg);
Respiratory irritation: waived

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
Study period:
from 2007-11-22 till 2007-12-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2004/73/EG, B.4
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
rbt, New Zealand White Hsd If:HZW
Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
other: aqua ad inject.
Controls:
other: The untreated other side served as control.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
none
Other effects:
No effects observed.
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item showed no irritant/corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
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
Study period:
from 2008-01-07 till 2008-01-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2004/73/EG, B.5
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
rbt, New Zealand White Hsd If:NZW (SPF)
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated contralateral eye served as control.
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0 - <= 0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days.
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item produced slightly to diffuse irritating effects, which were fully reversible.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 2001/59/EC) the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
only existing study is sufficient

Justification for selection of eye irritation endpoint:
only existing study is sufficient

Justification for classification or non-classification

According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding irritation/corrosion.