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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A valid skin irritation/corrosion and eye irritation study is available.

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: scientifically acceptable and sufficient documented
Principles of method if other than guideline:
Ca. 500 mg of the substance was applied on the inner ear of 2 rabbits for 24 hours. The post observation period was 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, (48), (96), 120 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Remarks on result:
other: reading was done in one rabbit at 48 hours and in the other rabbit at 96 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, (48), (96), 120 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Remarks on result:
other: reading was done in one rabbit at 48 hours and in the other rabbit at 96 hours

After the removal of the plaster bandages and during the following observation period of 7 days no erythema, edema or corrsion of the treated skin areas was found.

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Ca. 500 mg of the substance was applied on the inner ear of 2 rabbits for 24 hours. The post observation period was 7 days.

After the removal of the plaster bandages and during the following observation period of 7 days no erythema, edema or corrsion of the treated skin areas was found.Therefore the test substance KAC 4196 has no skin irritation/corrosion effects on rabbits.

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:
other: scientifically acceptable and sufficient documented
Principles of method if other than guideline:
Ca. 50 mg of the test substance KAC 4196 was applied into the conjunctival sac of 2 rabbits. The evaluation eas done 1 h, 24 h, 2 d, 3 d, 4 d, 7 d after instillation. The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no applicable - score = 0 at any time point

One hour and 24 hours after application of the test substance a slight reddening and swelling was observed.These findings are caused vy mechanical irritation of the eyes by the test substance. The reddening and swelling were reversible during the observation period of 7 days. cornea and iris revealed no findings.

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Ca. 50 mg of the test substance KAC 4196 was applied into the conjunctival sac of 2 rabbits. The evaluation eas done 1 h, 24 h, 2 d, 3 d, 4 d, 7 d after instillation. The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.

The mean cormeal opacity score after 24, 48, and 72 hours was 0, the iris score = 0, the redness conjunctivae score = 0.3 and the chemosis conjunctivae score = 0.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the skin irritation/corrosion study 2 white New-Zealand rabbits were treated onto the inside of the ear with ca. 500 µl of the test substance. The test item remained under semiocclusion for 24 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of plaster up to 7 days.

Erythema and edema score was 0 at any time point, after removal of plaster up to 7 days

In the eye irritation study one male and one female New Zealand white rabbit, 50 mg of the test substance/rabbit was applied into the conjunctival sac of one eye of each rabbit. The observation time was 7 days. Evaluation erythema and edma according to Draize.

The cornea, iris and chemosis score was 0 at any time point. The conjunctiva score was 0.3 out of 3.


Justification for selection of skin irritation / corrosion endpoint:
key study is used

Justification for selection of eye irritation endpoint:
key study is used

Justification for classification or non-classification

Due to the results of the skin irritation/corrosion study and the eye irritation study, both in rabbits, a classification is not justified.