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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No irritation on skin or eyes were observed in rabbits in vivo.

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)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
other: Rabbit (New Zealand White)
Type of coverage:
occlusive
Vehicle:
other: none
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
The application sites were stained yellow in all animals for up to 3 days after application. This staining did not, however, obscure the the assessment of any erythema present.This staining did not, however, obscure the assessment oferythema
Interpretation of results:
other: not classified
Conclusions:
Substance was a slight irritant to rabbit skin, following a single four-hour application
Executive summary:

Following a single four-hour application, very slight erythema was observed two days after application in one animal. Very slight oedema was also observed for up to two days after application in all animals. No other signs of skin irritation were observed.

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)
Qualifier:
according to guideline
Guideline:
other: Annex V - method B.5
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
CA 100 MG
Observation period (in vivo):
9 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 9d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 4d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4d
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 9 days
Other effects:
Additional signs of irritation included convoluted eyelids, mucoid and harderian discharge and dried secretions on the upper and lower eyelids. Fluorescein staining revealed superficial erosion of approximately one quarter of the cornes in one animal. None of these effects persisted beyond seven days.

Interpretation of results:
other: not classified
Conclusions:
The test substance was a mild irritant (class 4 on a 1-8 scale) to the rabbit eye and caused no, or practically no initial pain (class 0 to 1 on a 0-5 scale)
Executive summary:

A group of three female rabbits each received a single application of test substance into the left eye according to test method B.5. The animals were assessed daily for any signs of eye irritation for seven or nine days after application.

The test substance was a mild irritant (class 4 on a 1-8 scale) to the rabbit eye and caused no, or practically no initial pain (class 0 to 1 on a 0-5 scale)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Reliable studies (reliability 2) on skin irritation are available for the test substance. The test substance caused no skin effects (mean erythema or edema score = 0) or only slight transient effects (mean scores <= 1, i.e. well below the critical values for classification), which were fully reversible within the observation time, independently whether the exposure duration was 4 (rabbit) or 24 hours (rats).

In summary, it is concluded that the test substance is not irritating to skin and that is has not to be classified as skin irritants.

Eye irritation

A reliable study (reliability 2) on eye irritation is available for the test substance showed only some slight effects in the eyes. As the observed eye responses were all below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test substance is considered not to be irritating to eyes and therefore it should not to be classified for eye irritation.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Studies investigating skin and eye irritation did not reveal any or – if at all – only minimal evidence of irritant potential of the test substance, which were fully reversible. Therefore the substance should not to be classified as skin or eye irritants according to Regulation (EC) No 1272/2008 and Council Directive 67/548/.