Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
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:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Six groups of 5 male and 5 female Wistar rats were nose/head-only exposed to analytical concentrations of 0, 375.6, 906.5, 1968.9, 3292.8 or 7619.5 mg 3-chloro-p-toluidine/m³ air for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
aerosol dispenser: not specified
Details on test material:
3-chloro-p-toluidine (technically pure); purity: 99.5 %; vehicle: mixture of polyethylene glycol 400 and ethanol (1:1)

0,20 % p-Toluidine
0,01 % 4-Chlor0-3-toluidine
0,02 % 2-Chloro-4-nitrobenzene
99,5 % 2-Chloro-4-toluidine
0,03 % 6-Chlor0-3-toluidine
0,06 % 2,5-Dichloro-4-toluidine
0,07 % 2,6-Dichloro-4-toluidine + 3,4-Dichloranilin
0,06 % unknown compounds(5 compounds)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: polyethylenglycol - ethanol 1:1
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0, 375.6, 906.5, 1968.9, 3292.8 or 7619.5 mg 3-chloro-p-toluidine/m³ air.
No. of animals per sex per dose:
5 male and 5 female rats/dose
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7.62 mg/L air
Based on:
test mat.
Exp. duration:
4 h

Any other information on results incl. tables

At 7620 mg 3-chloro-p-toluidine/m³ air (maximal examined concentration) one of five female rats died. Clinical signs were a low irritation potential of mucuous membranes, methamoglobinemia and unspecific central nervous symptoms.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Six groups of 5 male and 5 female Wistar rats were nose/head-only exposed to analytical concentrations of 0, 375.6, 906.5, 1968.9, 3292.8 or 7619.5 mg 3-chloro-p-toluidine/m³ air for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.

At 7620 mg 3-chloro-p-toluidine/m³ air (maximal examined concentration) one of five female rats died. Clinical signs were a low irritation potential of mucuous membranes, methamoglobinemia and unspecific central nervous symptoms.

LC50 > 7.69 mg/L.