Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Version August 6, 1987
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate
EC Number:
269-507-4
EC Name:
Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate
Cas Number:
68259-05-2
Molecular formula:
C50 H42 Cl2 N6 O8
IUPAC Name:
2-chloroethyl 2-[(2Z)-2-[3-[[4-[[(4E)-4-[[5-(2-chloroethoxycarbonyl)-2-methylphenyl]hydrazinylidene]-3-oxonaphthalene-2-carbonyl]amino]-2,5-dimethylphenyl]carbamoyl]-2-oxonaphthalen-1-ylidene]hydrazinyl]-3-methylbenzoate
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: solide, insoluble in water
- Analytical purity: commercial grade
- Lot/batch No.: EN 81581.62
- Stability under test conditions: guaranteed
- Storage condition of test material: room temperature
Specific details on test material used for the study:
- Physical state: solide, insoluble in water
- Analytical purity: commercial grade
- Lot/batch No.: EN 81581.62
- Stability under test conditions: guaranteed
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: albino rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RAIf (SPF) hybrids (of RII/1 x RII/2) rats from Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 204-236 g
- Fasting period before study: overnight prior to dosing
- Housing: caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS (the animal room was air conditioned)
- Temperature (°C): 22±3°C
- Humidity (%): 55±15%
- Air changes (per hr): approx. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL

MAXIMUM DOSE VOLUME APPLIED:
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: mortality twice on working days and once on weekend days; signs and symptoms daily; body weight at start and on days 7 and 14
- Necropsy of survivors performed: yes; at the end of the observation period
Statistics:
From the body weights, the group means and their standard deviations were calculated

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 was observed at this unique dose level
Mortality:
No mortality occurred
Clinical signs:
other: - Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. - Additionally, a red discoloration of the body was observed from day 1 to 4 after administration. - The animals recovered within 11 days.
Gross pathology:
No deviations from normal morphology were found at necropsy

Any other information on results incl. tables

Table 1: Mean body weights (g) and standard deviation

Dose level (mg/kg bw)

Males

Females

Day 1

Day 7

Day 14

Day 1

Day 7

Day 14

5000

227±6.2

265±7.4

306±7.6

212±7.5

211±13.7

224±14.3

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information