Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Only data summary seen from SNIF docs
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
No data from SNIF file
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 animals
Vehicle:
water
Controls:
not required
Amount / concentration applied:
Applied to skin as moistened in water. 0.5g per animal
Observation period:
72 hours
Number of animals:
3
Remarks on result:
other: other: not classified

Comments: 4105 SKIN IRR RESULT: No dermal irritation. Localised light blue colouration after removing dressing, persisting for up to 72 hours. The substance is not a skin irritant. 22

Conclusions:
Data obtained through ECHA Inquiry under the 12 year rule.
Executive summary:

Data obtained through ECHA Inquiry under the 12 year rule.

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: Only data summary seen from SNIF docs
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks on result:
other: Other: not classified

4106 EYE IRR RESULT: Clear irritation noted immediately on application due, in part, to the physical state of the material. Moderate conjunctival and corneal irritation persisted for up to 48 hours post-dose, but cleared by 72 hours. The substance is not classified as an eye irritant.

Conclusions:
Data obtained through ECHA Inquiry under the 12 year rule.

Executive summary:

Data obtained through ECHA Inquiry under the 12 year rule.

 

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

Additional information

Not classified as skin or eye irritant on basis of animal testing for NONS notification.

Discolouration is caused they the test material.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification