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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
EC Number:
255-005-2
EC Name:
N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
Cas Number:
40618-31-3
Molecular formula:
C40H22Cl6N6O4
IUPAC Name:
N,N'-(2,5-dichloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
Test material form:
solid
Details on test material:
Description: Red solid
Batch number: W02002
Purity / Formulation: >99.91%
Stability of test item: Stable under storage conditions.
Expiry date: 20-AUG-2009
Stability of test item dilution: Unknown in PEG 300; excluded from the statement of compliance.
Storage conditions: At room temperature (range of 20 ± 5 °C, provided by RCC), light protected.
Specific details on test material used for the study:
Description: Red solid
Batch number: W02002
Purity / Formulation: >99.91%
Stability of test item: Stable under storage conditions.
Expiry date: 20-AUG-2009
Stability of test item dilution: Unknown in PEG 300; excluded from the statement of compliance.
Storage conditions: At room temperature (range of 20 ± 5 °C, provided by RCC), light protected.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environ-ment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Accomodation in groups of three.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
The application volume was 10 mL/kg body weight.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. In addition, viability and clinical signs were recorded 6-hour after dosing for animals 4−6 due to a misunderstanding in the laboratory. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred.
Mortality:
none
Clinical signs:
other: All animals expressed a slightly ruffled fur throughout the day of dosing. In addition, a hunched posture was noted in three animals at the 3-hour reading. Red staining of the feces was noted for all animals on days 2 and 3 and for the first dosing group
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met