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Toxicological information

Acute Toxicity: inhalation

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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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Four groups of 5 male and 5 female Wistar rats were nose/head-only exposed to an aerosol concentration of 1,8-naphthylendiamine at an analytical concentration of 0, 156, 413 or 877 mg/m³ (highest technical feasible concentration) 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
Details on test material:
purity: 99.5%

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: acetone-polyethylenglycol 400 in air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0. 156, 413 or 877 mg 1,8-naphthylendiamine/m³ air
No. of animals per sex per dose:
5 male and 5 female rats/concentration
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 877 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: highest technical feasible concentration

Any other information on results incl. tables

An exposition up to 877 mg/m³ 1,8-naphtylenediamine (highest technical feasible concentration) was tolerated without mortality. All animals exposed to 413 and 877 mg/m³ and revealed at the first exposition day a reduced motility and a bloody nose, additional one rat exposed to 413 mg/m³ a reduced respiration rate. All rats had no clinical symptoms at the first post-observation day. At the 3rd post-observation day in all rats exposed to 413 mg/m³ and in female rats exposed to 877 mg/m³ a reduction of weight gain was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Four groups of 5 male and 5 female Wistar rats were nose/head-only exposed to an aerosol concentration of 1,8-naphthylendiamine at an analytical concentration of 0, 156, 413 or 877 mg/m³ (highest technical feasible concentration) for 4 hours. The animals were

observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.

An exposition up to 877 mg/m³ 1,8-naphtylenediamine (highest technical feasible concentration) was tolerated without mortality. All animals exposed to 413 and 877 mg/m³ and revealed at the first exposition day a reduced motility and a bloody nose, additional one rat exposed to 413 mg/m³ a reduced respiration rate. All rats had no clinical symptoms at the first post-observation day. At the 3rd post-observation day in all rats exposed to 413 mg/m³ and in female rats exposed to 877 mg/m³ a reduction of weight gain was observed. Therefore the LC50 is > 877 mg/kg bw for male and female rats