Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
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-{[4-({4-[(E)-2-[4-({4-[(2,5-disulfophenyl)amino]-6-(morpholin-4-yl)-1,3,5-triazin-2-yl}amino)-2-sulfophenyl]ethenyl]-3-sulfophenyl}amino)-6-(morpholin-4-yl)-1,3,5-triazin-2-yl]amino}benzene-1,4-disulfonate
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
rabbit: Gelbsilber
sex/dose: 3M 3F
housing individual
accomodation: air-conditioned: temperature 23+/-2 °C, relative humidity 55+/- 5 %,
light-cycle: 14 hours artificial light per day
feed: Nafag Würfel Nr. 84
application: clipped, single application on intact skin, occlusive 24 hours according to Draize et al.
rinsing: luke-warm water
area: 200 - 300 cm²
Volume: 2.5 ml/kg
observation period: 8 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
None
Duration of exposure:
single exposure 24 hours occluded
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 M and 3 F
Control animals:
not specified
Details on study design:
None
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
2000 mg/kg: 6/6: day 1-8: no symptoms related to resorption
24 h; 4/6: Erythema
2.-6. day: 6/6: no observations
7.+8. day: 1/6: scaling
Body weight:
None
Gross pathology:
None
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
other: Not classified as toxic according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The acute dermal LD50 of the test substance the substance was found to be >2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the substance was performed on rabbits. However, no mortality was observed throughout the observation period. Hence, the acute dermal LD50 of the test substance was found to be >2000 mg/kg bw.