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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
skin was washed after and individual results not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate
EC Number:
248-420-5
EC Name:
Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Cas Number:
27344-06-5
IUPAC Name:
disodium 2,2'-ethene-1,2-diylbis[5-({4-[(3-amino-3-oxopropyl)(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl}amino)benzenesulfonate] (non-preferred name)
Details on test material:
- Analytical purity: approx. 100%

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: gum tragacanth
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso lumbar region
- % coverage: 10%
- Type of wrap if used: waterproof adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm (40-50°C) dilute soap solution
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 12.5 mL/kg
- Concentration (if solution): 40%
- Constant volume or concentration used: no

Duration of exposure:
24 hours
Doses:
5 g/kg body weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: There were no signs of toxicity. None of the rats showed any observable dermal reactions (including controls).
Gross pathology:
Terminal autopsy findings were normal.

Applicant's summary and conclusion