Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was performed between 2002-05-02 and 2002-05-05. Report signed off 202-12-23.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
443-510-2
EC Name:
-
Cas Number:
738587-10-5
Molecular formula:
C26H14N10Ni2O18S4 as free acid
IUPAC Name:
dinickel(2+) sodium 3-carboxy-5-[(1E)-2-(7-oxido-2,6-disulfonaphthalen-1-yl)diazen-1-yl]-1H-1,2,4-triazol-1-ide 3-carboxy-5-[(1E)-2-(7-oxido-2-sulfo-6-sulfonatonaphthalen-1-yl)diazen-1-yl]-1H-1,2,4-triazol-1-ide

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animals were in the weight range of 2.0 to 3.5 kg and were twelve to sixteen weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label. The animals were individually housed in suspended metal cages. Free access to mains drinking water and food was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of I7 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with veterinary clippers
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg (moistened with 0.5ml distilled water).
Duration of treatment / exposure:
4 hours
Observation period:
Test sites examined for primary irritation 1, 24, 48 and 72h after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: A 2.5cm x 2.5cm cotton gauze patch was placed in position on the shorn skin and secured with a strip of surgical tape. Tp prevent the animals interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: The patches were removed and any residual test substance was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: Four hours

SCORING SYSTEM:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema/Eschar formation
Basis:
animal: 115Male
Time point:
other: Score at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
other: No evidence of skin irritation
Remarks on result:
other: Pink/red coloured staining present
Irritation parameter:
other: Erythema/Eschar formation
Basis:
animal: 137 Male
Time point:
other: Score at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
other: No evidence of skin irritation
Remarks on result:
other: Pink/red coloured staining
Irritation parameter:
other: Erythema/Eschar formation
Basis:
animal: 139 Male
Time point:
other: Score at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
other: No evidence of skin irritation
Remarks on result:
other: Pink/red coloured staining
Irritation parameter:
other: Oedema formation
Basis:
animal: 115 Male
Time point:
other: Score at 24, 48 and 72 h
Score:
0
Max. score:
5
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 137 Male
Time point:
other: Score at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 139 male
Time point:
other: Score at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
other: No evidence of skin irritation
Irritant / corrosive response data:
No evidence of skin irritation or corrosivity were noted during the study.
Other effects:
Pink/red coloured staining was noted at all treated skin sites throughout the study. The staining did not affect evaluation of skin responses.

Any other information on results incl. tables

Interpretation of Results

Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

The scores for erythema and oedema at the 24 and 72 - Hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test item. The test item was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.47:

Primary Irritation Index

Classification of Irritancy

     0

Non-irritant

> 0 to 2

Mild irritant

> 2 to 5

Moderate irritant

> 5 to 8

Severe irritant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test substance did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Directive 2001/59/EC and Regulation (EC) No. 1272/2008
Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White Rabbit. The method was designed to be compatible with the following guidelines:

OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adopted 17 July 1992)

Commision Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)

Results

A single 4h semi-occluded application of the test substance to the intact skin of 3 rabbits produced no evidence of skin irritation. Pink/red coloured staining was noted at all treated skin sites throughout the study.

Conclusion

The test substance produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test substance did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Directive 2001/59/EC and Regulation (EC) No. 1272/2008