Registration Dossier

Administrative data

Description of key information

Non skin irritating 
Non irritating to eye

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:
From 6 to 9 march 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Few details
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
Single 4 hours application
Observation period:
1, 24, 48 and 72 hours after administration
Number of animals:
3
Details on study design:
SCORING SYSTEM:
Primary irritation index / classification
- 0: non-irritant
- >0-2: mild irritant
- >2-5: moderate irritant
- >5-8: severe irritant
Irritation parameter:
other: Erythema/eschar formation
Basis:
other: 65954 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
other: Erythema/eschar formation
Basis:
other: 65956 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
other: Erythema/eschar formation
Basis:
other: 65957 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
edema score
Basis:
other: 65954 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
edema score
Basis:
other: 65956 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
edema score
Basis:
other: 65957 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritant / corrosive response data:
Primary irritation index: 0.0
No evidence of skin irritation was noted. Red-coloured staining was noted at two treated skin sites one hour after patch removal.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Executive summary:

A study was performed to assess the initation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.10). The method followed OECD Guidelines for Testing of Chemicals (24 April2002) No. 404 "Acute Dermal Initation/Corrosion" and Method B4 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 671548/EEC). The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.

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
Study period:
From 12 to 26 march 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Poory details
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: single application of 0.1 ml (76.6 mg)
Duration of treatment / exposure:
Single application
Observation period (in vivo):
1, 24, 48 amd 72 hours and 7 days after administration
Number of animals or in vitro replicates:
3
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal: All rabbits (65967, 66032 and 66033 males)
Time point:
other: 1, 24, 48, 72 hours and 7 days
Score:
ca. 10
Reversibility:
fully reversible
Irritant / corrosive response data:
The test material produced moderate conjunctival irritation.
Dark red-coloured staining of the lower conjunctival and nictitating membranes and red-coloured staining of the fur around the treated eye were also noted. One treated eye appeared normal at the 72-hour observation and the two remaining treated eyes appeared normal atthe 7-day observation
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE)
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.09), The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Initation/Corrosion" and Method B5 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC).

Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE). The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/corrosion

Three studies on four are according to identify Direct Red 23 (DR23) as skin not irritating; Clariant 2002 study has been performed with DR23 at 87.5% and Clariant 2007 with DR23 at 70%.

The studies on structural analogues Direct Red 239 and Direct Red 262 confirm the not irritability for skin of DR23 .

 

Eye irritation

It was noted that test material produced moderate conjunctival irritation, reported in Clariant 2007 report. It is possible that the DR23 could be irritating to eye in some conditions, expecially if in powder form; however the eventually disadvantages can be easy obviated by correctly using of the substance with the necessary preautions.

In any case none of those effects are enough to classify the substance as irritant, according to CLP regulation (EC1272/2008).

 

Respiratory irritation

Tests on this pourpose have not been conducted; nevertheless DR23 is not expected to be a respitatory irritant.

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) Direct Red 23 is not classified as skin/eye/respiratory irritant.