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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:
other: read across from similar substance
Adequacy of study:
key study
Study period:
march 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not GLP compliant but good described study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: REAL DECRETO 363/1995, 10 march
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Acid Brown 75
IUPAC Name:
Acid Brown 75

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: authorized supplier.
- Weight at study initiation: 2033-2113 g
- Housing: Stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water: filtered tap water (5 µm) , ad libitum
- Acclimation period: 7 days
- Health check: during observation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2°C
- Humidity (%): 55 ± 25%
- Air changes (per hr): 15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod : 12 hour cycle dark/light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied:0.5 g
Duration of treatment / exposure:
4 hours of treatment
Observation period:
1, 24, 48 ,72 hours and 7+14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:dorsal-column area near the spine, forming a rectangle 20 cm x 13 cm .
- % coverage: 6 cm^2
- Type of wrap if used: simple bandage and covered in turn with a light hypoallergenic adhesive bandage .

REMOVAL OF TEST SUBSTANCE
- Washing : yes

SCORING SYSTEM: erithema and edema (similar to OECD 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Other effects:
no data

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 the substance did not show any irritation properties.
Executive summary:

The substance was tested for skin irritation following OECD 404 . Three New Zealand white rabbits were tested with an occlusive method. After 14 days of observation no rabbit shows signs of erythema or edema. The substance is classified as non-irritating to the skin.