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 / corrosion, other
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 6 to 9 march 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable for the assessment of the endpoint.
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: 0.0No 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, other
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 12 to 26 march 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable for assess the endpoint.
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:
The test material did not meet the criteria for classification as irritant according to EU labelling regulations.
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).

The test material did not meet the criteria for classification as irritant according to EU labelling regulations.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/corrosion

Based on the results of the available in vitro and in vivo tests, no skin irritating effects were observed.

Eye irritation

Based on the results of the available in vitro and in vivo tests, no eye irritating effects were observed.

 

Respiratory irritation

Tests on this pourpose have not been conducted; nevertheless Direct Orange 102 is not expected to be a respitatory irritant.

Justification for classification or non-classification

According to CLP regulation (EC 1272/2008) Direct Orange 102 is not classified as skin/eye/respiratory irritant.