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Description of key information

In an early and limited study the compound was concluded to be corrosive to the skin after 24 h of exposure to the skin with effects not reversible after a recovery time of 7 days. The test material was highly irritating and caused corrosion on the cornea of the rabbit eyes when applied at a dose level of 50 mg.

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 study with limited information on test material, test animals, study design and clinical examination.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
limited information on test material, test animals, study design and clinical examination, exposure period too long, no guideline compliant application area
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
24 h
Observation period:
7 days
Reading time points: 24, 48 and 72 h and 7 days
Number of animals:
2 (1 male, 1 female)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
other: not reversible within 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 7 days
Other effects:
The test material was highly irritating on rabbit skin (ear) when applied at a dose level of 500 mg. Either scab formation or necrosis was oberved.
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Executive summary:

In this early and limited study the compound was concluded to be corrosive after 24 h of exposure to the skin with effects not reversible after a recovery time of 7 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-GLP study with limited information on test material, test animals, study design and clinical examination
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited test material, testing animal and study design information, only 50 mg was applied to the animals which is not guideline-compliant
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Duration of treatment / exposure:
single application of 0.05 g without washing
Observation period (in vivo):
7 days
Reading time points: 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
2 (1 male, 1 female)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
other: not reversible within 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
other: not reversible within 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
other: not reversible within 7 days
Other effects:
The test material was highly irritating and caused corrosion on the cornea of the rabbit eyes when applied at a dose level of 50 mg.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

The test material was highly irritating in an in viov study and caused corrosion on the cornea of the rabbit eyes when applied at a dose level of 50 mg.

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

In an early and limited study the compound was concluded to be corrosive to the skin after 24 h of exposure to the skin with effects not reversible after a recovery time of 7 days. The test material was highly irritating and caused corrosion on the cornea of the rabbit eyes when applied at a dose level of 50 mg. The substance will be labelled with skin corr. cat 1 (based on the available in vivo data no subcategory can be assigned) and Eye irrit. cat 1 (irreversible damage to the eye).