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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: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 4 DEC 1989 to 18 DEC 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 403)
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990
Reference Type:
publication
Title:
Investigation of possible metabolism of Pigment Yellow 17, a 3,3'-dichlorobenzidine-based pigment, after inhalation exposure in rats
Author:
Hofmann T, Schmidt D
Year:
1993
Bibliographic source:
Arch. Toxicol. 67: 141-144
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]
EC Number:
224-867-1
EC Name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]
Cas Number:
4531-49-1
Molecular formula:
C34H30Cl2N6O6
IUPAC Name:
2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(2-methoxyphenyl)-3-oxobutanamide]
Test material form:
solid: nanoform

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: males mean: 227 g; females mean: 195 g
- Housing: macrolon cages (type 4) groups of 5 respectively 2 (= control animal and animal killed 1 day post application)
- Diet: rat diet Altromin 1324 ( Altromin-GmbH, Lage/Lippe, Germany); ad libitum
- Water: Tap water; ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical plastic cage
- Exposure chamber volume: 60 L
- Method of holding animals in test chamber: each animal was in a plastic tube
- Source and rate of air: laminar air stream of 1000 L/hour at 4 bar from above
- System of generating particulates/aerosols: dustgenerator "Wright Dust Feed" of L. Adams Ltd., London, UK
- Method of particle size determination: "Anderson-Kaskadenimpaktor Mark III" of Anderson Samples Inc, Atlanta, USA
- Treatment of exhaust air: exhaust device at the basement of the exposure chamber in line with a diverse system of filters

TEST ATMOSPHERE ANALYSIS
- Brief description of analytical method used: gravimetric measurement: The test atmosphere was sucked through filters ("Experimentiertrommelgasfilter", Elster AG, Mainz-Kastel, Germany; as well as a fibre glass and a membrane filter (diameter of pores 0.65 µm) Satorius Membranfilter GmbH, Göttingen, Germany) by means of vacuum. The exhaust quantity was 3 L/min, which resulted in an air flow of 1.25 m/sec. The filters were positioned in an exsiccator 24 h before use. The filters were weighed before and after each measurement by means of electrical scales.

TEST ATMOSPHERE
- Particle size distribution: < 0.6 µm to > 10.3 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.0 - 1.1/ 2.3 - 2.8
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric measurement
Duration of exposure:
4 h
Concentrations:
230 mg/m³ air
No. of animals per sex per dose:
6/sex/treatment group
1/sex/control group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

- Control urine and blood samples were collected from control animals.
- On day 1, 2 and 7 one male and one female were sacrificed to obtain blood samples. Final sacrifice of the remaining 3 animals/sex was on day 14 of the observation period.
- Urin samples were collected starting on the day of exposure till day 7 of the observation period and the last night before sacrifice.
- To collect urine the rats were placed in metabolism cages overnight without witdrawal of food and water. For technical reasons urine was collected continously on day 6 and 7.
- Blood was collected via puncture of the retro-orbital plexus.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 230 mg/m³ air
Exp. duration:
4 h
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
- no deaths occurred
Clinical signs:
other: - during the exposition: irregular breathing, narrowed palpebral fissures and female animals showed additional stilted gate - no more clinical signs were observed in males 330 minutes p.a. and in females 450 minutes p.a.
Body weight:
- Body weight development was impaired in the first week, probably due to the frequent placement in metabolism cages.
- But all animals except for one female did excess their initial body weight at the end of the test period.
Gross pathology:
- no macroscopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
Exposure of male and female Wistar rats to 230 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 230 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Wistar rats. They were exposed to 230 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 230 mg/m³ for the inhalation of dust.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .