N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]

Endpoint summary

Description of key information

Non hazardous after single oral dosing up to the limit dose of 2000 mg/kg bw (OECD 423, GLP).

Non hazardous after acute inhalation (read-across).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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.

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.

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

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.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Reliable and valid.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

2 mg/L air

Physical form:

inhalation: aerosol

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Pigment Red 214 was tested in two valid studies in rats (RCC 1989 and 2006). Both studies are GLP and OECD 423 compliant. No animal died at the limit dose of 2000 mg/kg bw. In the more recent study, 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 already at the 5-hour reading.No macroscopic findings were recorded at necropsy. In the other study, all rats had recovered within three observation days from sedation and unsteady gait and ruffled fur. The results are consistent with poorly documented information indicating an LD50 of greater than 15000 mg/kg bw (Andrysova 1978).

 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008.