Registration Dossier
Registration Dossier
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EC number: 916-632-3 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- poor documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Version / remarks:
- study pre-dates creation of guidelines but a method similar to OECD TG 402 is likely
- Principles of method if other than guideline:
- 4 hours dermal treatment with subsequent observation
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 270-629-5
- EC Name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68460-07-1
- Molecular formula:
- C28H22N8O8S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 272-559-0
- EC Name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68877-33-8
- Molecular formula:
- C28H23N9O7S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 260 - 280 g (mean 270 g)
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: gauze patch, covered with plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
- For solids, paste formed: moistened with propylene glycol - Duration of exposure:
- 4 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 4 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: after 4 hours, 2, 6, 9, 13 and 14 days
- Frequency of weighing: after 2, 6, 9, 13, 14 days
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: at the first two readings after 4 hours and 2 days the treated skin was discoloured by the test material. In addition, reddened skin was noted in 2 animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) No. 1272/2008
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008. - Executive summary:
In a pre-guideline study the acute dermal toxicity was investigated in 4 male rats.
In a limit test the acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
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