p-phenylenediamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study was not conducted under GLP; only 1 sex (males); no environmental or exposure apparatus details reported; frequency of observations and weights not reported. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Only males were tested; no environmental conditions, exposure apparatus details, or frequency of observations or weights reported

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Details on test material:

- Purity: 99.5%

Test animals

Species:

rat

Strain:

other: Crl:CD®

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 236-272 g
- Fasting period before study: None
- Housing: Animals were housed in pairs in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:

other: vapor at <0.54 mg/L; aerosol at ≥0.54 mg/L

Type of inhalation exposure:

nose only

Vehicle:

other: air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Not reported
- Exposure chamber volume: Not reported
- Method of holding animals in test chamber: Not reported
- Source and rate of air: Not reported
- Method of conditioning air: Not reported
- System of generating particulates/aerosols: The test material was heated (115-189ºC) in a round bottom flask. Heated nitrogen (53-70ºC) was blown through the flask, sweeping test substance vapors into a dilution air stream. Prior to chamber entry, oxygen was added to the mixture.
- Treatment of exhaust air: Not reported
- Temperature, humidity, pressure in air chamber: ≤35°C; humidity and pressure not reported; oxygen greater than or equal to 20%

TEST ATMOSPHERE
- Brief description of analytical method used: Test atmospheres were sampled by drawing chamber atmosphere through a fritted glass impinger containing methanol as the trapping solvent. The frit was immersed in the methanol. If the airflow stopped (completion of sampling), the frit filled with methanol (the trapping agent). Samples were analyzed by a GC equipped with a flame ionization detector. Samples were chromatographed isothermally at 130ºC on a glass column packed with 3% OV-17 on 80/100 mesh Chromosorb® W. Sample concentrations were determined by comparison with a standard cure.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0.07, 0.30, 0.54, 0.94, or 1.8 mg/L

No. of animals per sex per dose:

10 male rats/concentration

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: No

Statistics:

The LC50 was calculated by the method of Finney.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

0.92 mg/L air

95% CL:

0.59 - 1.9

Exp. duration:

4 h

Mortality:

No deaths at 0.07 mg/L, 1/10 deaths at 0.30 mg/L, 4/10 deaths at 0.54 mg/L, 5/10 deaths at 0.94 mg/L, 7/10 deaths at 1.8 mg/L. All deaths occurred within 48 hours.

Clinical signs:

other: During exposure: No overt signs at 0.07 mg/L. At higher concentrations rats showed red nasal discharge. Cyanosis was observed at 1.8 mg/L. During 14 day observation: At all concentrations rats showed red ocular discharge or brown-stained fur around the

Body weight:

In a dose-dependent fashion, slight to severe weight loss for 3 days followed by weight gain was observed.

Applicant's summary and conclusion

Interpretation of results:

moderately toxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). LC50 (rats) = 0.92 mg/L

Executive summary:

An inhalation medial lethal concentration (LC₅₀) for the test substance was determined in male Crl:CD^®rats given single 4-hour exposures. The calculated LC₅₀ is 0.92 mg/L with 95% confidence limits of 0.59 and 1.9 mg/L.