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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 January 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
EC Number:
246-058-2
EC Name:
N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
Cas Number:
24170-60-3
Molecular formula:
C19H19N7O5
IUPAC Name:
N-{2-[(2-cyano-4,6-dinitrophenyl)diazenyl]-5-(diethylamino)phenyl}acetamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 43'693.12

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: until October 1988

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2240-2390 g
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad liitum
- Water: water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Remarks:
Using electric clipper
Vehicle:
water
Remarks:
The substance was water moistened before application
Controls:
no
Amount / concentration applied:
0.5 g of the test substance was applied.
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3 females
Details on study design:
- Application of the Substance: Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm, by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non-irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water moistened before application.

SCORING SYSTEM:
Evaluation of the dermal reactions.
Erythema and Eschar formation:
- No erythema: 0
- Very slight erythema: 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation: 4
- Corrosion: +

Oedema formation:
- No oedema: 0
- Very slight oedema: 1
- Slight oedema: 1
- Slight oedema (edges of area well defined by definite raising) 2
- Moderate oedema (approx. 1mm): 3
- Severe oedema (raised more than 1 mm, extended beyond. appl. site): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
Due to intensive blue staining by the test substance a scoring of the erythema values was not possible
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 7 d
Other effects:
Due to intensive blue staining by the test substance a scoring of the erythema values was not possible.
The dermal irritation was evaluated after the score for oedema formation only.
The animals showed a normal body weight development.

Any other information on results incl. tables

Scoring of erythema and eschar formation:

Animal No. / Sex 1 hr 24 hrs 48 hrs 72 hrs 7 days  
22 / F * * * * *
23 / F * * * * *
24 / F * * * * *
Total * +  * +  * +  *           = * (A)

Scoring of Oedema formation:

Animal No. / Sex 1 hr 24 hrs 48 hrs 72 hrs 7 days  
22 / F 1 1 1 1 0
23 / F 0 0 0 0 0
24 / F 2 1 1 0 0
Total 3 + 2 +  2 + 1 =   8 (B)

Index of skin irritation: A* + B = 1.33

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36156/A is non irritant when applied to the rabbit skin.
Executive summary:

The study was performed to determine the acute dermal irritation/corrosion potential of FAT 36156/A on New Zealand rabbits according to the OECD guideline 404. Three female rabbits were used in the test; 0.5 g of the test item was applied to the skin of the rabbit which was shaved not less than 24 hours before the application. The exposure duration was 4 hours. After removal of the dressing, the skin reaction was assessed (for erythema and oedema) after 1, 24, 48, 72 hours and during the 7 days of observation period. The animals showed a normal body weight development. Due to intensive blue staining by the test substance, the scoring of the erythema values was not possible. The dermal irritation was evaluated after the score for oedema formation only. The calculated dermal irritation index was 1.33 for oedema. The animals had recovered at the end of the observation period of 7 days. Under the conditions of the present experiment, FAT 36156/A was found to be slightly irritant and not corrosive when applied to the rabbit skin. However, as per the Regulation (EC) No. 1272/2008, it does not need to be classified.