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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

not skin irritant

not eye 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 analogue substance
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
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Vehicle:
other: moistened with water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Irritant / corrosive response data:
Erythema score: maximum duration is 0 days. Maximum value at the end of observation period: 0 (related to all animals)
Edema score: maximum duration is 0 days. Maximum value at the end of observation period: 0 (related to all animals)
Other effects:
A test at scarified skin of 6 further rabbits also did not reveal any irritation effect
Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
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 analogue substance
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
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
6
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24 and 48h
Score:
0
Max. score:
0
Other effects:
Lids were strongly swelled and strong secretion
Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
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 for skin and eye irritation following EU Method B4 and B5 respectively. In vivo resutls are available showing no irritating potential for skin and eye.

Based on the read across considerations the same applies to Direct Blue 299:1.

Justification for classification or non-classification

The substance is not classified as skin irritant under Regulation 1272/2008

The substance is not classified as eye irritant under Regulation 1272/2008