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Diss Factsheets

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: Guideline and GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
other: Acute Inhalation Toxicity study
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,5-naphthylenediamine
EC Number:
218-817-8
EC Name:
1,5-naphthylenediamine
Cas Number:
2243-62-1
Molecular formula:
C10H10N2
IUPAC Name:
1,5-naphthylenediamine
Details on test material:
purity: 98.4 %; applied as dust (middle diameter of particles: 8.16, 8.63 µm resp.)

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: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
2010; 5270 mg/m³ air
No. of animals per sex per dose:
5/sex/dose
Control animals:
yes

Results and discussion

Effect levels
Dose descriptor:
LC50
Effect level:
>= 5.27 mg/L air
Exp. duration:
4 h
Mortality:
see: remarks on results
Clinical signs:
other: see: executive summary
Body weight:
The body weights of the animals in group 3 were diminuated in the observation period after experiment.
Gross pathology:
see: executive summary

Any other information on results incl. tables

Akute Inhalation Toxicity: dust

 No.of group  Concentration (mg/m³ air)  Toxicological result        duration of symptoms  Timepoint of death  Particle < 5 µm (%)
                      Rat male
 1 Air-control  0*  0**  10***  --  --  --
 2  2010  0  0  5  --  --  29
 3  5270  0  5  5  4d-5d  --  26
                 Rat female     
 1  Air-control  0  0  10  --  --  --
 2  2010  0  0  5  --  --  29
 3  5270  2  3  5  3d-6d  4d  26

*- Number of mortalities

**- Number of animals with symptoms

***- Number of animals used

LC50 male rat: > 5270 mg/m³ air

LC50- female rat: ca. 5270 mg/m³ air

Applicant's summary and conclusion

Executive summary:

5 male and 5 female Wistar rats (170 -200g) per group were treated in an acute inhalation toxicity test with the test substance for 4 hours.

The observation period was 14 days.

Symptoms of toxicity observed were: reduced motility, decelerated breathing, ruffled hair (occurred in the second half of the first week of the observation period); 2 females died after 4 days; macroscopical findings in female rats: hydrothorax, reddened renal pelvis, dark and enlarged spleen, pale liver with marked lobules, reddened gastrointestinal tract.

The LC50 for male rats was > 5,27 mg/l.

The LC 50 for female rats was ca. 5,27 mg/l.

The NOEL was 2,01 mg/l.