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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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).