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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as metioned below
Principles of method if other than guideline:
Acute dermal toxicity study of test chemical in rabbits.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Details on test material:
Name: Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
Smiles -c1(N2CCOCC2)nc(Nc2cc(c(\C=C\c3c (cc(Nc4nc(N5CCOCC5)nc(n4)Nc4ccccc4)
cc3)S(=O)(=O)[O-])cc2)S(=O)(=O)[O-])nc(n1)Nc1ccccc1.[Na+].[Na+]
InChI - 1S/C40H40N12O8S2.2Na/c53-61(54,55)33-25-31(43-37-45-35(41-29-7-3-1-4-8-29)47-39(49-37)51-17-21-59-22-18-51)
15-13-27(33)11-12-28-14-16-32(26-34(28)62(56,57)58)44-38-46-36(42-30-9-5-2-6-10-30)48-40(50-38)52-19-23-60-24-20-52;;
/h1-16,25-26H,17-24H2,(H,53,54,55)(H,56,57,58)(H2,41,43,45,47,49)(H2,42,44,46,48,50);;/q;2*+1/p-2/b12-11+;;
- Molecular formula (if other than submission substance): C40H38N12Na2O8S2
- Molecular weight (if other than submission substance): 924.928 g/mole
- Substance type: organic

Test animals

Species:
rabbit
Strain:
other: Albino rabbit
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Type of coverage:
other: Dermal - intact and abraded sites
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: intact and abraded sites
REMOVAL OF TEST SUBSTANCE
- Washing (if done): unabsorbed test material was removed
- For solids, paste formed: yes, test material was applied in the form of paste in polyethylene glycol
Duration of exposure:
24 h
Doses:
5000 mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for clinical signs and gross pathology examination.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No Mortality observed
Mortality:
No Mortality observed at 5000 mg/kg
Clinical signs:
Moderate erythema disappearing by day 4, was observed; but there were no signs of systemic toxicity.
Body weight:
not specified
Gross pathology:
No gross pathologic changes were observed.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The LD50 was considered to be >5000 mg/kg bw, when albino rabbits were treated with given test chemical occlusively for 24 h exposure by dermal application to intact and abraded sites.
Executive summary:

Acute Dermal toxicity study was conducted in rabbits using test chemical at the concentration of 5000 mg/kg bw. Test material was applied in the form of paste in polyethylene glycol to both intact and abraded sites on rabbits.After occlusion for 24 hr, unabsorbed test material was removed and treated sites were examined for local reactions. After an observation period of 14 days, the animals were sacrificed and examined for gross pathologic changes.No Mortality observed at 5000 mg/kg bw.Moderate erythema disappearing by day 4, was observed; but there were no signs of systemic toxicity.No gross pathologic changes were observed. Therefore, LD50 was considered to be >5000 mg/kg bw, when albino rabbits were treated with test chemical occlusively for 24 h exposure by dermal application to intact and abraded sites.