Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
29.09.1977-20.01.1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions, not GLP but subject to QA audit.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Method: other: in house protocol
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tradename Dobanol 91 Type B

- Physical state:

- Storage condition of test material:

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: hell Toxicology Laboratory (Tunstall) Breeding Unit,  Sittingbourne, Kent, UK
- Age at study initiation:  11 weeks approximately
- Weight at study initiation: males 327-391g; females 190-240
- Housing: initially the animals were segregated into equal weight distribution groups, but after exposure the animals were individually housed in hanging polypropylene cages with stainless steel wire mesh floor and top.
- Diet: ad libitum
- Water: tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20
- Humidity (%): ca. 55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: vapours
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: tubular glass chambers
- Exposure chamber volume: 5 litres
- Method of holding animals in test chamber: stainless steel mesh carriers, accommodating 5 animals each
- Source and rate of air: 10 litres/minute
- System of generating particulates/aerosols: the test atmosphere was generated by means of a wick-type saturator maintained at 42C in a thermostat water bath and were supplied to two identical glass inhalation chambers each of volume 5 litres.


TEST ATMOSPHERE
- Brief description of analytical method used: The atmospheric concentration of the test material was measured continuously throughout the exposure by means of a total hydrocarbon analyser fitted with a flame ionisation detector.

Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
Two separate exposures were made as follows firstly to  an atmosphere containing 0.212 mg/l of the more volatile components of  Dobanol 91 and secondly to an atmosphere containing 0.237 mg/l of the  less volatile components (atmospheres were analysed continuously  throughout exposure using a total carbon analyser and flame ionisation  detector). In both cases the test atmospheres were near saturated.
No. of animals per sex per dose:
5M+5F/group  
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs were continuously observed for the first 30  minutes of exposure then at 15 minute intervals throughout exposure and  twice daily thereafter throughout the 14 day observation period. Initial  and terminal bodyweights were recorded. Gross post mortem examination was carried out on all animals.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.237 mg/L air
Exp. duration:
4 h
Mortality:
All animals survived the 4 hour exposure period and subsequent  14 day observation period.
Clinical signs:
other: No signs of toxicity. All animals gained weight normally  over the observation period.
Body weight:
The body weight gains were within normal limits.
Gross pathology:
None reported.
Other findings:
POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The rat 4 hour inhalational LC50 for Dobanol 91 was found to be >0.237 mg/l (near saturated vapour concentration). There were no signs of toxicity at this exposure level.

This study was reported in Iuclid 2000.