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Administrative data

Description of key information

Skin irritation: not irritant
Eye irritation: not irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the irritation potential. Source study has reliability 2: only limited information available from a migrated NONS file, as per Article 25(3) request.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Irritation parameter:
erythema score
Basis:
animal: all
Score:
ca. 0
Reversibility:
other: no skin irritation observed
Remarks on result:
no indication of irritation

Blue discolouration of skin noted but not sufficient to occlude the assessment of erythema. No signs of irritation were observed.

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant.
Executive summary:

Method

Test conducted according to OECD guideline 404. No details on method are available. Information from migrated NONS file, as per Article 25(3) request with permission to refer granted by ECHA.

Results

Blue discolouration of skin noted but not sufficient to occlude the assessment of erythema.No signs of irritation were observed. 

Not irritant.

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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the irritation potential. Source study has reliability 2: only limited information available from a migrated NONS file, as per Article 25(3) request.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks on result:
other: lack of details; data from migrated NONS file

Moderate conjunctival response with chemosis noted at 1 hour and redness at 24 hours. By 72 hours only slight conjunctival redness in one animal. The substance is not classifiable as an eye irritant.

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant.
Executive summary:

Method

Test conducted according to OECD guideline 405. No details are available. Information derived from migrated NONS file, as per Article 25(3) request with permission to refer granted by ECHA.

Results

Moderate conjunctival response with chemosis noted at 1 hour and redness at 24 hours. By 72 hours only slight conjunctival redness in one animal.

Not irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on irritation/corrosion potential of Direct Blue 273 was available. Therefore, the assessment was based on available data on Similar Substance 1, i.e. an isomer of Direct Blue 273. The read across approach was considered as appropriate; further details are included in section 13.

Information on the Similar Substance 01 derived from a migrated NONS file with permission to refer granted by ECHA. Details on testing method, animals and procedures are lacking.

 

Skin irritation

A test was conducted on Similar Substance 01, according to OECD guideline 404. Under test conditions, blue discolouration of skin was noted but it was not sufficient to cause erythema. No signs of irritation were observed.

 

Eye irritation

A test was conducted on Similar Substance 01,according to OECD guideline 405. Under test conditions, test substance showed moderate conjunctival response with chemosis noted at 1 hour and redness at 24 hours. By 72 hours only slight conjunctival redness was seen in one animal.

Justification for classification or non-classification

Skin irritation

According to the CLP Regulation (EC 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

A substance has to be classified as Category 1 (Corrosive) if there is the production of irreversible damage to the skin in more than 1 of 3 animals.

 

A substance has to be classified as Category 2 (Irritant) if shows:

- mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

- inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

- in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

Under test conditions, no signs of irritation in terms of erythema/eschar and oedema reactions were reported. Therefore, based on a read across approach, Direct Bue 273 was not classified as skin irritant.

 

Eye irritation

According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

A substance has to be classified as Category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of:

- corneal opacity ≥ 3 and/or

- iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

 

A substance has to be classified as Category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:

at least in 2 of 3 tested animals, a positive response of:

- corneal opacity ≥ 1 and/or

- iritis ≥ 1, and/or

- conjunctival redness ≥ 2 and/or

- conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Under test conditions, chemosis and redness were reported at 24 hours; however, only slight redness was still present in one animal at 72 hours, thus indicating a tendency to regress. On these bases, a classification as eye irritant was not applied to Similar Substance 01.

Based on a read across approach, Direct Blue 273 was not classified as eye irritant.