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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Remarks:
other: five days.
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system (only 5 consecutive days).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report date:
1956

Materials and methods

Principles of method if other than guideline:
The effect of the 5 -days repeated skin administration to five rats was evaluated. 20 mg were given to each animal.
GLP compliance:
no
Remarks:
Pre GLP.

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
EC Number:
237-600-9
EC Name:
Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Cas Number:
13863-31-5
Molecular formula:
C38H40N12Na2O8S2
IUPAC Name:
disodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[(2-hydroxyethyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: gum arabic
Details on exposure:
TEST SITE
- Area of exposure: back.

TEST MATERIAL
- Amount applied: 0.4 ml
- Concentration: 5 %
- Constant volume or concentration used: yes.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
5 days.
Frequency of treatment:
Daily.
Doses / concentrations
Dose / conc.:
20 mg/kg bw/day (nominal)
Remarks:
Doses / Concentrations:
20 mg/animal
Basis:
no data
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Results of examinations

Details on results:
After 8 days no abnormalities detected.

Effect levels

Dose descriptor:
NOAEL
Effect level:
20 other: mg/animal
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: no effects up to the highest dose

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
After 8 days no abnormalities detected in animals exposed to 20 mg of the test substance.
Executive summary:

Method

The effect of the 5 -days repeated skin administration to five rats was evaluated. 20 mg were given to each animal.

Result

After 8 days no abnormalities detected.