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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Species:
rabbit
Type of coverage:
semiocclusive
Duration of treatment / exposure:
4 hours
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks on result:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks on result:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: summary provided by ECHA 2014
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks on result:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks on result:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks on result:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks on result:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Remarks:
Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Irritant / corrosive response data:
not classified as irritant
Interpretation of results:
not classified
Remarks:
Migrated information
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Species:
rabbit
Amount / concentration applied:
MG
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
2
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean scire 2)
Time point:
24/48/72 h
Score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
1
Reversibility:
other: summary provided by ECHA 2014
Remarks on result:
other: summary provided by ECHA 2014
Interpretation of results:
irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on eye irritation: irritating

Justification for classification or non-classification