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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.

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
Study period:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(reported as Annex V)
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
not specified
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
No other effets reported
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the substance was determined to not be irritating to skin
Executive summary:

In a study conducted to OECD Guideline 404 (equivalent to the standardised EU Annex V method B4) under conditions of GLP, no signs of edema or erythema were noted at any of the observation points in any of the animals tested. As such the substance is considered to not be irritating to skin.

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:
supporting study
Study period:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Reported as "equivalent to Annex V)
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
No data
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0

Slight, transient conjunctival irritation was noted, but no other signs were reported.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the substance was determined to not be irritating to eyes
Executive summary:

In a study conducted to OECD Guideline 405 (equivalent to the standardised EU Annex V method B5) under conditions of GLP, the substance was noted to cause slight, transient conjunctival irritation in the one instance. As such the substance is considered to not be irritating to eyes.

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

Additional information

Skin

In a study conducted to OECD Guideline 404 (equivalent to the standardised EU Annex V method B4) under conditions of GLP, no signs of edema or erythema were noted at any of the observation points in any of the animals tested. As such the substance is considered to not be irritating to skin.

Eye

In a study conducted to OECD Guideline 405 (equivalent to the standardised EU Annex V method B5) under conditions of GLP, the substance was noted to cause slight, transient conjunctival irritation in the one instance. As such the substance is considered to not be irritating to eyes.


Justification for selection of skin irritation / corrosion endpoint:
Only available data source.

Justification for selection of eye irritation endpoint:
Only available data source.

Justification for classification or non-classification

Based on the results of the available study summaries, the substance does not meet the criteria for classification for irritating to either skin or eyes.