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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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 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:
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

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.

Conclusion

Inhalation of vapour saturated atmosphere of 2,6 -Xylidine did not represent a severe health hazard.