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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
other: read across from similar substance
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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
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 informationCriteria 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.
Executive summary:

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

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:
other: read across from similar substance
Adequacy of study:
key study
Study period:
From 12 to 26 march 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Brief report
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
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 informationCriteria 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

Direct Orange 26 could be considered as not irritant.

The results of the studies available on similar substances confirm that this family of dye, ureids, is not irritating to skin and eyes.

Skin Irritation/corrosion

All of the available studies performed on similar substances does not show any irritating effects on skin.

 

Eye irritation

Based on the results of the available studies should be noted that test material produced moderate conjunctival irritation.

None of those effects are enough to classify the substance as irritant, according to CLP regulation (EC 1272/2008).

 

Respiratory irritation

Tests on this pourpose have not been conducted; nevertheless Direct Orange 26 is not expected to be a respitatory irritant.

Justification for classification or non-classification

The CLP Regulation inidcates the following values for the classification fo skin and eye irritation.

Skin irritant cat 2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions;

or

2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling;

or

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Eye irritant Cat 2: at least in 2 of 3 tested animals, a positive response of:

1) corneal opacity ≥ 1

and/or

2) iritis ≥ 1

and/or

3) conjunctival redness ≥ 2

and/or

4) conjunctival oedema (chemosis) ≥ 2 5calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

According to CLP regulation (EC1272/2008) Direct Orange 26 is not classified as skin/eye/respiratory irritant.