Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only abstract available

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
4-Aminoazobenzene
Author:
Beratergremium für Altstoffe (BUA)
Year:
1998
Bibliographic source:
BUA-Stoffbericht 217. BUA der Gesellschaft dt. Chemiker, S. Hirzel Wissenschaftliche Verlagsgesellschaft, Stuttgart
Reference Type:
study report
Title:
Unnamed
Year:
1993
Reference Type:
secondary source
Title:
IUCLID
Author:
ECB
Year:
2007
Bibliographic source:
ECB IUCLID Dataset
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-Aminoazobenzene
- Analytical purity: 98.7%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
head only
Vehicle:
other: acetone/polyethyleneglycol (1:1)
Details on inhalation exposure:
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter): 62 - 93% of the aerosol particles had a MMAD of ≤ 3µm


Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0, 0.023, 0.341, 2.80 mg/l analytical concentration
No. of animals per sex per dose:
5 female and 5 male animals per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.8 mg/L air
Exp. duration:
4 h
Mortality:
no mortality occured
Clinical signs:
at mid and high dose bradypnoe, cyanosis;
reduced body temperature at mid and high dose;
dose dependent increase in methemoglobin concentration (marginal at low dose);
no symptoma of intoxication reported on the 4th day after exposure
Body weight:
reduced body weight gain at high dose
Gross pathology:
no treatment related effects observed at macroscopical pathology

Applicant's summary and conclusion