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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study following official guideline non GLP compliant. The value at 48h is missing. For the calculation of edema mean score the worse value recorded between 24 and 72h is considered.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
2014

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Acid Black 52
IUPAC Name:
Acid Black 52

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Source: Breeding Farm VELAZ
Acclimatisation: minimum 5 days
Total number: 3 healthy adult animals
Housing: individually caged withotu bedding in conventional animal room
Diet: pelleted standard diet (Velaz)
Water: dringking tap water ad libitum
Microclimatic conditions: room temperature 17-23°C permanently monitored
Relative humidity: 30-70% permanently monitored
light: 12 hours light/dark cycle
Identification of animals: code number on inner side of ear of animal, number of study on each cage
Health condition: certificate of good heltah condition-from breeding farm; no sogns of diseases were observed at clinical check-in, in acclimatisation period and before the start of experiment

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and scarified
Vehicle:
other: moistened with water
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4 hours
Observation period:
1,24,48 and 72h
Number of animals:
3
Details on study design:
Approximately 24 hours before application the fur on the dorsal area of the trunk was removed by close-clipping (area- 6 x 6). Only animals with healthy intact skin were used. The same area was prepared for test with scarification-the skin lesions were prepared by incisions in stratum corneum.
The test item was used in delivered form. The test item was applied on intact skin (and on scarified skin) and then it was covered by gauze patch, foil and cellulose cotton and held in place with non-irritating tape - Spofaplast (semi-occlusive dressing). At the end of each exposure period the patch was removed and remaining sample was washed with water.

Clinical observation of the animals was carried out before application and daily during the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24 h
Score:
ca. 3
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
48 h
Score:
ca. 3
Reversibility:
no data
Remarks on result:
other: the value at 48h is missing in the original report. Worst result between 24 and 72h is supposed and used in the mean score value
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24 h
Score:
ca. 4
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
48 h
Score:
ca. 4
Reversibility:
no data
Remarks on result:
other: the value at 48h is missing in the original report. Worst result between 24 and 72h is supposed and used in the mean score value
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24 h
Score:
ca. 2
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
48 h
Score:
ca. 2
Reversibility:
no data
Remarks on result:
other: the value at 48h is missing in the original report. Worst result between 24 and 72h is supposed and used in the mean score value
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #4
Time point:
24 h
Score:
ca. 3
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #4
Time point:
48 h
Score:
ca. 3
Reversibility:
no data
Remarks on result:
other: the value at 48h is missing in the original report. Worst result between 24 and 72h is supposed and used in the mean score value
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #4
Time point:
72 h
Score:
ca. 2
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #5
Time point:
24 h
Score:
ca. 4
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #5
Time point:
48 h
Score:
ca. 4
Reversibility:
no data
Remarks on result:
other: the value at 48h is missing in the original report. Worst result between 24 and 72h is supposed and used in the mean score value
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #5
Time point:
72 h
Score:
ca. 3
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #6
Time point:
24 h
Score:
ca. 2
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #6
Time point:
48 h
Score:
ca. 2
Reversibility:
no data
Remarks on result:
other: the value at 48h is missing in the original report. Worst result between 24 and 72h is supposed and used in the mean score value
Irritation parameter:
edema score
Remarks:
scarified skin
Basis:
animal #6
Time point:
72 h
Score:
ca. 0
Reversibility:
no data
Irritant / corrosive response data:
intact skin edema mean score animal # 1= 2
intact skin edema mean score animal # 2 = 2.6
intact skin edema mean score animal # 3 = 1.3
scarified skin edema mean score animal # 4 = 2.6
scarified skin edema mean score animal # 5 = 3.6
scarified skin edema mean score animal # 6 = 1.3

Erythema scores were recorded only at 72h due to skin discolouration, and therefore are not used in the irritative response assessment.
Other effects:
There was no evidence of a corrosive effect on the skin. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The substance was tested for skin irritation following OECD 404. Under the experimental conditions did not show any skin irritation properties.
Executive summary:

The test substance was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test.

 Test was performed according to method OECD Guideline for Testing of Chemicals No. 404 - Acute Dermal Irritation/Corrosion, Adopted 12 May 1981, with internal procedure modification. Three rabbits were exposed to 0.5 g of the test sample, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made 1, 24, and 72 hours after exposure.            

The evaluation of erythema was not possible, because the test substance caused coloration of skin. Moderate or severe oedema was observed in animals after 24 hours. 72 hours after patch removal only very slight erythema in two animals was observed. Moderate, slight or very slight oedema on scarified skin was observed in animals.