Registration Dossier

Administrative data

Description of key information

skin irritation, rabbit, semiocclusive, not irritating
eye irritation, rabbits, not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier on analogue substance
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Observation period:
24, 48 and 72h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24,48 and 72h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
study GLP compliant performed on a similar substanceThe study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier on analogue substance
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 1.7
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 0.7
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 1.3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 1
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72h
Score:
ca. 0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The analogue substance was tested in two in-vivo studies for skin and eye irritation folloiwng EU Method B4 and B5 (1989).

The substance did not show to be irritant for skin and eye irritation over 3 animals as mean value of 24, 48 and 72h observations.

Based on the read across considerations Acid Black 233:1 is not considered as eye and skin irritant

Justification for classification or non-classification

Based on the results the classification for skin and eye irritation is not warrented under Regulation 1272/2008.