2,6-xylidine

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: Comparable to guideline (OECD 403, inhalation hazard test) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; low number of rats)

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)

Version / remarks:

IHT, Inhalation hazard test

GLP compliance:

no

Test type:

other: IHT, Inhalation hazard test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-xylidine

EC Number:

201-758-7

EC Name:

2,6-xylidine

Cas Number:

87-62-7

Molecular formula:

C8H11N

IUPAC Name:

2,6-dimethylaniline

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2,6-Dimethylanilin
- Physical state: brown liquid
- Analytical purity: no data
- Stability under test conditions: 6 months if oxygen is excluded

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr . K . Thomae GmbH, Biberach, D (SPF breed: SPF-Wistar/Chbb:THOM)
- Age at study initiation: 8 weeks
- Mean weight at study initiation: males 242 g(233-257 g); females 193 g (168-214g)
- Housing: 3 per cage
- Diet (e.g. ad libitum): Sniff R 10mm, Sniff, Soest, D
- Water (e.g. ad libitum): ca. 250 mL tap water/ cage*d
- Acclimation period: at least 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12:12

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Rats exposed for 7 h to a vapour saturated atmosphere.
Vapour was generated by bubbling 200 l/h dry air (no CO2) through the liquid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder. The glass cylinder was heated in a water bath. The air pressure was 754 mm Hg. Temperature in the exposure chamber was 20°C.
The vapour saturation was calculated to be ca. 1.00 mg/L (at 20°C). Therefore, the test atmosphere has to be considered as vapour.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

0.75 mg/L (mean of 0.71 and 0.79 mg/L)

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 11 days
- Frequency of observations and weighing: No weighing was done. Observation was several times at the day of exposure and presumably daily except on weekends and holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

not performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: inhalation hazard test

Effect level:

0.75 mg/L air

Exp. duration:

7 h

Remarks on result:

other: no mortality observed

Mortality:

No mortality observed

Clinical signs:

other: during exposure: salivation, aqueous eye secretion and muzzles wiping; after exposure: salivation, apathy, closed eyes and slight secretion of the nose; all effects reversible after 1d

Body weight:

not performed

Gross pathology:

Necropsy revealed no morphological changes 14 d after exposure.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Inhalation of vapour saturated atmosphere of 2,6 -Xylidine for 7 hours in an inhalation hazard test did not cause mortality in rats.

Executive summary:

Study is comparable with the inhalation hazard test (IHT) described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 10 days). Rats were exposed for 7 h to a vapour saturated atmosphere (0.75 mg/L). 0/12 animals died after the 7 h exposure. Salivation, apathy, closed eyes and slight secretion of the nose were reversible within one day. There was no finding at necropsy at the termination of the study.