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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: see 'Remark'
Remarks:
Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days [but no deaths expected in the 2nd week])

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
Annex of the Guideline 403
Deviations:
no
GLP compliance:
no
Test type:
other: inhalation hazard test

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
mean weight: 180 g
No further details

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
Rats exposed for 8 h to a vapour saturated atmosphere.
Vapours generated by bubbling 200 l/h air at 20°C through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 hours.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
Saturated vapour.
No. of animals per sex per dose:
6 males and 6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations performed (no details), body weight determined at day 0 and 7
- Necropsy of survivors performed: yes, 7 days after inhalation exposure
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
other: saturated vapour
Exp. duration:
8 h
Remarks on result:
other: IHT
Mortality:
No mortality
Clinical signs:
other: Symptoms: Immediately after the start of exposure, the animals showed attempts to escape, after 1 hour an irritation (slight irritation; BASF AG, 1966) of mucous membranes (BASF AG, 2004; no further details). No clinical signs and findings from the first
Body weight:
No data
Gross pathology:
Necropsy: 3 out of 12 animals showed chronic bronchitis. This finding is judged to be caused by the breeding and housing conditions and not to represent an exposure related effect. No macroscopic pathologic abnormalities were noted in the other animals.
Other findings:
No

Applicant's summary and conclusion

Conclusions:
No mortality in male and female rats exposed to saturated vapour at 20°C for 8 h.
Executive summary:

Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days [but no deaths expected in the 2nd week]).

Six male and 6 female rats were exposed for 8 h to saturated vapour generated at a temperature of 20°C. Immediately after the start of exposure, the animals showed attempts to escape, after 1 hour slight irritation of mucous membranes was detected. No clinical signs and findings from the first post observation day onward were found. No mortality occurred during the 7 days of post exposure observation period. No effects were detected at necropsy.

Conclusion: No mortality in male and female rats exposed to saturated vapour at 20°C for 8 h.