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)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5g moistened with 0.5ml of water
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48 and 72h after exposure
Number of animals:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal: #1 and #3
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h and 72h
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: No separate control animals were included. Only one eye was treated per animal and the other eye remaining untreated, serves as reference control.
Amount / concentration applied:
49mg (a volume of approximately 0.1ml)
Duration of treatment / exposure:
about one second
Observation period (in vivo):
Observations were made:
- mortality: twice daily
- toxicity: at least once daily
- body weight: day of treatment prior to instillation
- irritation: 1, 24, 48 and 72h after instillation.
Number of animals or in vitro replicates:
3 of one sex
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean 24 - 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Irritation of the conjunctivae was seen as redness, chemosis and discharge.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean 24 - 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Treatment with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24 - 72 hours
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Only study record shared of reliability 1. No additional value (= same result + no higher reliability possible) of non-shared data from FEW or Kodak.

Justification for selection of eye irritation endpoint:
Selection of key study (although both key and supporting study reveal no eye irritation).
As only one study can be indicated as key study, the first received report was indicated as key study and the second one as supporting study.
No additional value (= same result + no higher reliability possible) of non-shared data from FEW.

Justification for classification or non-classification