Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
other: method described in Official newspaper of FrenchRepublic (1982-02-22)
GLP compliance:
yes
Species:
rabbit
Type of coverage:
semiocclusive
Vehicle:
water
Duration of treatment / exposure:
24 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
1
Remarks on result:
other: Max. duration: 72 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
1
Remarks on result:
other: Max. duration: 72 d; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Interpretation of results:
other: not classified
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
other: clinical quotation
Deviations:
no
Principles of method if other than guideline:
The clinical quotation is made 30 minutes after the patch removal and takes in account the erythema, the papules, the vesicles and the blisters. According to their intensity, the quotation is spread out from 0 to 3. The total sum of the scores, divided by the number of volunteers, defines the mean irritation index (M.I.I.), which allows to classify arbitrarily the test item into “non irritant, slightly irritant, moderately irritant, very irritant and severely irritant"
GLP compliance:
no
Species:
human
Details on test animals or test system and environmental conditions:
Normal skin without any dermatological lesion on the experiental area
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Single application of 5 mg of the studied test item pure on the external face of the arm
Duration of treatment / exposure:
48h in contact with the skin, with the help of a semi-occlusive patch
Observation period:
Clinical quotation made 30 minutes after the patch removal
Number of animals:
20 volunteers of the female or male sex from 18 to 65 years old
Irritation / corrosion parameter:
other: other: mean irritation index (M.I.I)
Value:
0
Remarks on result:
other:
Remarks:
Basis: other: human. Time point: 48 hours. Reversibility: no data. (migrated information)
Other effects / acceptance of results:
The mean irritation index (MII) of the test item is 0. The test item can be considered as non-irritant
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: Methode officicelle pour l'evaluation de l'irritation oculaire
Version / remarks:
Method described in J.O. of 10/07/92
Principles of method if other than guideline:
Methode officicelle pour l'evaluation de l'irritation oculaire
GLP compliance:
no
Species:
rabbit
Strain:
other: Albinos
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
72h
Observation period (in vivo):
1h, 24h, 48h and 72h
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Comments:This test was realized by a laboratory which is not certified by BPL.
The observation of ocular lesions was not pursued beyond 72 hours after the product application. At
this time, it remained an eryhtema of conjonctiva level 1 in one rabbit.
Given the weak irritation, there is no need to think that this substance could cause an irreversible effect.
It is not appeared a justification to make this test again.
Interpretation of results:
GHS criteria not met
Conclusions:
The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only
one significant and usual reaction of conjonctiva without no particular consequence. Considering the
small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official
numerical classification, the product is completely lacking in any irritant effect for the ocular mucous
membrane
Executive summary:

The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only

one significant and usual reaction of conjonctiva without no particular consequence. Considering the

small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official

numerical classification, the product is completely lacking in any irritant effect for the ocular mucous

membrane

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification