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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

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-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide
EC Number:
279-211-7
EC Name:
N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide
Cas Number:
79665-24-0
Molecular formula:
C44H34Cl2N6O4
IUPAC Name:
2-Naphthalenecarboxamide, N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[2-(5-chloro-2-methylphenyl)diazenyl]-3-hydroxy-
Test material form:
solid: bulk
Details on test material:
- Substance type: red solid
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: AL 56/37+38
- Expiration date of the lot/batch: December 31, 1988
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: males: 8 weeks, females: 9 weeks
- Weight at study initiation: ma 1es : 199 - 230 g, females: 169 - 179 g
- Fasting: overnight (12 - 18h)
- Housing: five rats per cage
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
Temperature (°C): 20+-3 degrees centigrade
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1988-08-29 To:1988-09-12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5000 mg/20 ml
- Amount of vehicle (if gavage): 20 ml/kg bw

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality: Four times during test day 1, and daily during days 2-15; Body weights Test days 1 (pre-administration) , 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred
Mortality:
none
Clinical signs:
other: sedation, dyspnea (males), hunched posture, ruffled fur. All rats had recovered within six observation days.
Gross pathology:
No findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU