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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
Study period:
29.09.1977-20.01.1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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
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

Constituent 1
Reference substance name:
Alcohols, C9-11
EC Number:
266-367-6
EC Name:
Alcohols, C9-11
Cas Number:
66455-17-2
IUPAC Name:
Alcohols, C9-11
Details on test material:
Referenced in historical documentation (ICCA/OECD HPV) as Alcohols, C6-12, CAS 68603-15-6, compositional type B

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: hell Toxicology Laboratory (Tunstall) Breeding Unit,  Sittingbourne, Kent, UK
- Age at study initiation:  11 weeks approx
- 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 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
Key result
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:
GHS criteria not met
Conclusions:
The acute inhalation toxicity study for the analogue Alcohols, C9-11, conducted according to a protocol similar to OECD Test Guideline 403, but without information on GLP compliance, reports an LC50 value of >0.237 mg/l following 4-hour inhalation exposure to the vapour of Alcohols, C9-11.