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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:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
Principles of method if other than guideline:
The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]
EC Number:
235-558-6
EC Name:
Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]
Cas Number:
12286-66-7
Molecular formula:
C17H16N4O7S.1/2Ca
IUPAC Name:
calcium bis[4-({1-[(2-methylphenyl)carbamoyl]-2-oxopropyl}diazenyl)-3-nitrobenzenesulfonate]

Test animals

Species:
rabbit
Strain:
other: English Silver strain
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: 2-3 kg
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C):/
- Humidity (%):/
- Air changes (per hr):/
- Photoperiod (hrs dark / hrs light):/

IN-LIFE DATES: From: To:/

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and left hand side abraded
Vehicle:
other: 50 % polyethylene glycol suspension
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% solution

VEHICLE
- PEG 400
Duration of treatment / exposure:
24h
Observation period:
72h
Number of animals:
6 (3 per sex)
Details on study design:
TEST SITE
- Area of exposure: back and flanks
- % coverage: /
- Type of wrap if used: A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- no washing

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is to be considered as non-irritant to the skin of rabbits.