Registration Dossier

Administrative data

Description of key information

The substance is is severely irritating and corrosive to the skin, eyes and respiratory tract.

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:
other: Non GLP, non guideline study
Qualifier:
no guideline followed
Principles of method if other than guideline:
No data.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
open
Preparation of test site:
other: abraded and unabraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
4-72 hours
Observation period:
30 days
Number of animals:
18
6 per group
Irritation parameter:
other: Corrosion score
Basis:
mean
Time point:
other: 4 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
Irritation parameter:
other: Corrosion score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
Irritation parameter:
other: Corrosion score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
Irritation parameter:
other: Corrosion score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive effects on intact and abraded skin, not reversible after 30 days.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 Hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
The substance is severely corrosive to the skin of rabbits. Corrosive effects observed on intact and abraded skin, not reversible after 30 days.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is severely corrosive to the skin of rabbits. Corrosive effects observed on intact and abraded skin, not reversible after 30 days.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
other: Non-guidleine, non-GLP study.
Qualifier:
no guideline followed
Principles of method if other than guideline:
No data.
GLP compliance:
no
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml of undiluted test substance administered to the eye of each animal.
Duration of treatment / exposure:
5 minute exposure and 24-hour exposure
Observation period (in vivo):
Observations at 5 mins, 24hours and 48 hours.
30 days recovery.
Number of animals or in vitro replicates:
2 groups of 8
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 5 minutes
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 5-minute exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 5 minute and and 24 hour exposures
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 5 minute and and 24 hour exposures
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 24 hour exposure
Irritant / corrosive response data:
The substance is severely corrosive to the eyes of rabbits. Effects were immediate and severe, and irrevesible after a 30-day recovery period.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is severely corrosive to the eyes of rabbits. Effects were immediate and severe, and irrevesible after a 30-day recovery period.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Irritation study study using the test substance. The substance is is severely irritating and corrosive to the skin, eyes and respiratory tract.

Justification for selection of eye irritation endpoint:
Occular Irritation study study using the test substance. The substance is is severely irritating and corrosive to the skin, eyes and respiratory tract.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Harmful. The substance is is severely irritating and corrosive to the skin, eyes and respiratory tract.