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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 27 APR 1989 to 15 JUN 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
o-anisidine
EC Number:
201-963-1
EC Name:
o-anisidine
Cas Number:
90-04-0
Molecular formula:
C7H9NO
IUPAC Name:
2-methoxyaniline
Details on test material:
- Name of test material (as cited in study report): o-Anisidin D

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-breed
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: males mean: 208 g; females mean: 197 g
- Housing: grouped (5 animals per cage) in macrolon cages (type 4) in fully airconditioned rooms
- Diet: rats diet Altromin1324 (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: aerosol
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 plastic tube
- Source and rate of air: laminar air stream of 800L/h at 4 bar from above
- Method of particle size determination: "Anderson-Kaskadenimpactor 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
- Temperature, humidity, pressure in air chamber: air control system of Hartman&Braun

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
at dose 2.17 mg/l: <0.6 µm to 7 µm
at dose 3.87mg/l: <0.6 µm to 4.8 µm
- MMAD (Mass median aerodynamic diameter):
at dose 2.17 mg/l: 1.71
at dose 3.87mg/l: 1.58
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
4 h
Concentrations:
2.17 and 3.87 mg/l (highest technically feasible exposure concentration)
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: twice daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 3.87 mg/L air
Exp. duration:
4 h
Remarks on result:
other: higest technically feasible exposure concentration, no animals died during the 14 days observation period
Mortality:
- no deaths occured
Clinical signs:
other: - impairment of movement, respiration and reflexes were observed, as well as blood nasal discharge and cyanosis - all animals were free of clinical signs from day 8 after application
Body weight:
- body weight development in two female animals was impaired during the first week of the test. Nevertheless, they gained weight within the second week of the experiment.
- in all other animals body weight development was not impaired
Gross pathology:
- no macrosopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Exposure of male and female Wistar rats to the highest technically feasible concentration of 3.87 mg test item o-Anisidin D per L air for 4 hours did not result in the death of the animals during a 14 days observation period, resulting in a LC50 value of > 3.87mg/L air. The test results are adequate to fulfil the endpoint requirements.
Executive summary:

Acute inhalation toxicity of the test item o-Anisidin D has been investigated in male and female Wistar rats according to a standard acute method (OECD TG 403). They were exposed to 2.17 or 3.87 mg test substance per liter air for 4 h (maximal applicable dose). All animals survived the 14 days observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 3.87 mg/L for the inhalation of aerosol.