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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt
EC Number:
276-521-4
EC Name:
Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt
Cas Number:
72245-24-0
Molecular formula:
not applicable
IUPAC Name:
Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Housing: in single cages
-Diet: standard laboratory diet, ad libitum
-Water: standard laboratory water were provided ad libitum
-Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
-Temperature: 21 ± 2°C
-Humidity: 30 - 70 %
-Air changes: 15 changes/hour.
-Photoperiod: 12 hours cycle dark/light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: DMSO
Controls:
not specified
Amount / concentration applied:
1 ml of a 50 % DMSO solution

Duration of treatment / exposure:
4 h
Observation period:
30 min and 24, 48 and 72 h after the removal of the dressings
Number of animals:
three male rabbits
Details on study design:
TEST SITE
-% coverage: 6.5 cm²
-Type of wrap: patches secured in place by a plastic patch and the entire trunk wrapped with a plastic sleeve

SCORING SYSTEM
Erythema and Edema
No finding: 0
Barely perceptible effect: 1
Slight, well defined effect: 2
Moderate: 3
Severe: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No findings

Applicant's summary and conclusion

Interpretation of results:
other: not irritating for rabbit skin
Conclusions:
The substance was found to be not irritant for rabbit skin.
Executive summary:

The skin irritation test was evaluated in an in vivo test performed following a method similar to the OECD Guideline 404 method. 1 mL of test item solution were applied on the intact clipped skin of three male rabbits. The following observation period was of 72 hours.

No signs of skin irritation were noted. The erythema and edema scores (mean values at 24/48/72 h) were 0 in all animals.