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Diss Factsheets

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

Justification for classification or non-classification

A classification for skin and eye irritation does not apply to the substance.