Registration Dossier

Administrative data

Description of key information

Studies conducted to recognised testing guidelines with GLP certification.

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:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
other: OECD [C(99) 186 (Final)]
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Other effects:
No clinical signs, either general or local (at the application sites), were noted in any animal.
Interpretation of results:
GHS criteria not met
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:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
other: OECD [C(99) 186 (Final)]
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
9
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
ca. 2.77
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 3
Irritation parameter:
chemosis score
Basis:
mean
Score:
ca. 2.66
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
1.27
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2
Irritation parameter:
iris score
Basis:
mean
Score:
1.22
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
In the group of six rabbits, notable occular changes consisting of conjunctival redness and chemosis, iris congestion and corneal opacity were noted up to 72 hours - 7 days after exposure.

Thre native animals were trated at the same dose of 0.1 of test article, but eyes were washed at 2-3 mins after application, then observed and scored as for the previous six animals. Slight ocular changes, confined to conjunctival redness were noted up to 24 hours after exposure.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification