Alcohols, C9-11-branched and linear

Acute Toxicity: inhalation

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

Test material information

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.