Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study based on OECDguideline 412 with a five days exposure

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
Deviations:
yes
Remarks:
exposure 5 x 6 hours
Principles of method if other than guideline:
Ten male an ten female rats were exposed on 5 consecutive days for 6 hours per day nose/head only to an aerosol of 10, 75 or 394 mg 1,8-naphthylenediamine/m³ under dynamic conditions. The post-exposere time was 3 (intermediate section) or 17 days (endsection).
The animals were observed for mortality and clinical signs. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
content: 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: ethanol/polyethyleneglycol
Duration of treatment / exposure:
6 hours each on 5 consecutive days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 10, 75 or 394 mg/m³
Basis:
analytical conc.
No. of animals per sex per dose:
10 male and 10 female rats/dose
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:
NOAEC
Effect level:
75 mg/m³ air (analytical)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The exposition to the test substance was tolerated by all animals without mortality. Animals exposed to 394 mg/m³ 1,8-naphtylene- diamine revealed a decreased motility and a reduction in body weight gain.

A concentration dependant decrease of the rectal temperature was evident at a concentration of 10 mg/m³.

A decrease of the leucocyte number and an increase of the bilirubin concentration in plasma was found on animals exposed to 394 mg/m³.

The relative spleen weight was reduced in male rats at 394 mg testsubstance/m³.

All effects were reversible within the post-observation period.

Applicant's summary and conclusion

Executive summary:

Ten male an ten female rats were exposed on 5 consecutive days for 6 hours per day nose/head only to an aerosol of 10, 75 or 394 mg 1,8-naphthylenediamine/m³ under dynamic conditions. The post-exposere time was 3 (intermediate section) or 17 days (endsection).

The animals were observed for mortality and clinical signs. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation.

The exposition to the test substance was tolerated by all animals without mortality. Animals exposed to 394 mg/m³ 1,8-naphtylene- diamine revealed a decreased motility and a reduction in body weight gain. A concentration dependant decrease of the rectal temperature was evident at a concentration of 10 mg/m³. A decrease of the leucocyte number and an increase of the bilirubin concentration in plasma was found on animals exposed to 394 mg/m³. The relative spleen weight was reduced in male rats at 394 mg testsubstance/m³. All effects were reversible within the post-observation period.

Animals exposed to 394 mg 1,8-naphylenediamin revealed effects induced by the test material. Based on the hypothermic effect on animals exposed to 10 mg 1,8-naphthylendiamine a NOEL could not be established. The NOAEC is regarded to be 10 mg 1,8 -naphthylenediamine/m³.