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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: Basic data given (comparable to guidelines).

Data source

Reference
Reference Type:
publication
Title:
The inhalation hazard test; principle and method
Author:
Klimisch, H.J.
Year:
1988
Bibliographic source:
Arch. Toxicol. 61, 411 - 416

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
: Inhalation Hazard Test (See Annex)
Deviations:
yes
Remarks:
For each exposure time only 3 animals of each sex were used instead of 5 for each sex. Analytical purity not reported. Housing condition of the animals was not reported.
GLP compliance:
not specified
Test type:
other: Inhalation Hazard Test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chlorobenzene
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure system used in conventional inhalation toxicity studies. Two simple all-glass systems with tubes suitable for the exposure of six to ten animals.
- Exposure chamber volume: (V=1-2 L). Flow-through exposure tube (glass).
- System of generating particulates/aerosols: A glass flask generator was used for generation of a vapor saturated inhalation atmosphere
- Temperature, humidity, pressure in air chamber: 20 °C , no more data


Analytical verification of test atmosphere concentrations:
yes
Remarks:
was determined gravimetrically from the weight loss of the material and the volume of air passing through the generator.
Duration of exposure:
>= 0.17 - <= 1.8 h
Concentrations:
66 mg/L (nominal concentration)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: LT0
Effect level:
66 mg/L air
Exp. duration:
0.17 h
Remarks on result:
other: LT0= exposure time after which no animals died within 14 days.
Sex:
male/female
Dose descriptor:
other: LT50
Effect level:
66 mg/L air
Exp. duration:
1.8 h
Remarks on result:
other: exposure time after which 50% of the animalss died within 14 days.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Any other information on results incl. tables

The LC50 was calculated by the applicant according to the Haber´s rule ( Haber F, 1924. Fünf Vorträge aus den Jahren 1920 -1923, Verlag von Julis Springer) :

c x t = constant; t= LT50/normal exposure period

66 mg/L *1.8h/4h= 29.7 mg/L.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Executive summary:

Klimisch H.J., 1988.

The Inhalation Hazard Test was performed to determine the hazard of volatile substances in general and chlorobenzene in particular. Glass flask generator was used for the generation of a vapor saturated inhalation atmosphere. The exposure system used was made of two simple glass systems with tubes for the exposure of six to ten animals. 3 male and 3 female rats have been exposed to 66 mg/L (nominal concentration) and LT0 (time T after which no animals died within 14 days of post-exposure observation period) and LT50 (time of exposure after which 50% of the animals died within 14 days of the post-exposure observation period) were calculated

LT0 was estimated to be 0.17 h. LT 50 value was calculated from IHT results. LT50=1.8 h.

The LC50 was calculated by the applicant according to the Haber´s rule: LC50= 66

(1.8/4)*= 29.7 mg/L.

The study was performed according to OECD guideline 403 with deviations (For each exposure time only 3 animals of each sex were used instead of 5 for each sex. Analytical purity not reported. Housing condition of the animals was not reported).

The study was considered as reliable with restrictions.