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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:
From August 8, 1989 to August 11, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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:
7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
EC Number:
287-574-8
EC Name:
7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
Cas Number:
85536-87-4
Molecular formula:
C20H19N3O11S3.xNa C20H(19-x)N3NaxO11S3
IUPAC Name:
7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
Test material form:
solid: particulate/powder
Details on test material:
Reactive Orange 72/78

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2.9-3.4 Kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Altromin 2123 (Altromin GmbH, Lage/Lippe) ad libitum and hay (approx. 15g daily)
- Water: water from automatic water dispenser ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20 %
- Lighting time: 12 hours daily

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Remarks:
to form a paste
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g, with 0.55 ml of isotonic saline solution

VEHICLE
- Amount(s) applied: 0.55 mL of isotonic saline
Duration of treatment / exposure:
4 hours
Observation period:
examination after 30-60 minutes, 24, 48, and 72 hours.
Number of animals:
3
Details on study design:
TEST SITE
- Preparation: about 24h before the start of the study the hair in the dorsal region on the body was removed with an electric clipped over an area of 25 cm^2. Only animals with intact skin were used.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster (produced by Beiersdorf Aktiengesellschaft)

REMOVAL OF TEST SUBSTANCE
- washing: yes, with warm tap water
- Time after start of exposure: after 4 hours

SCORING SYSTEM: according to the score of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of systemic toxicity were observed during the 72 hours of observation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is detemined to be not irritating to the skin.
Executive summary:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.

Each animal was treated with 0.5 g test substance pasted with 0.55 ml isotonic saline. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

No signs of irritation occurred during the whole study.

The skin of the animals was discoloured orange 30 - 60 minutes after removal of the patches up to the end of the study.

Testing for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.