Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: test technique as 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).
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
EC Number:
257-827-7
EC Name:
Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)
Cas Number:
52301-70-9
Molecular formula:
C40H40N12O20S6.6Na
IUPAC Name:
hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Housing: single metal cages
- Diet (e.g. ad libitum): Nafag ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-1 °C
- Humidity (%): 55+/-5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
The substance was applied to each side in quantities of 0.5 ml.
Duration of treatment / exposure:
24 h
Observation period:
The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 9 days.
Number of animals:
6 (3 Males and 3 Females)
Details on study design:
6 rabbits ( 3 males; 3 females) of the Russian breed, weighing 1.4 to 1.7 kg, were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. The substance was applied to each side in quantities of 0.5 ml . The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 9 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: with intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: with intact skin
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

Scores for erythema

Erythema with intact skin
Animal Observation time
24 hours 48 hours 72 hours
1 0 0 0
2 0 0 0
3 0 0 0
4 1 0 0
5 0 0 0
6 1 0 0
Mean 0.33 0 0

Erythema with abraded skin
Animal Observation time
24 hours 48 hours 72 hours
1 1 1 0
2 1 1 0
3 1 0 0
4 1 0 0
5 1 1 1
6 1 0 0
Mean 1.00 0.50 0.17

Scores for oedema

Oedema with intact skin

Animal Observation time
24 hours 48 hours 72 hours
1 0 0 0
2 0 0 0
3 0 0 0
4 0 0 0
5 0 0 0
6 0 0 0
Mean 0 0 0

Oedema with abraded skin
Animal Observation time
24 hours 48 hours 72 hours
1 0 0 0
2 0 0 0
3 0 0 0
4 0 0 0
5 0 0 0
6 0 0 0
Mean 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: Not classified as irritant according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The substance was found to cause a slight erythema without oedema with the intact skin. Hence, it does not warrant classification as per the Regulation EC No. 1272/2008.
Executive summary:

The skin irritation potential of the test item was evalauted in a study conducted according to the patch test technique as 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). The test item was applied to each side of the shaved flank region of 6 Russian breed rabbits in quantities of 0.5 ml . The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediatly to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 9 days. A slight erythema without oedema was observed with the intact skin. Hence, the test item does not warrant classification as per the Regulation EC No. 1272/2008.