Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
2 rats/sex exposed (whole body) for 4 hours to atmospheres of Shellsol A and observed for the following 14 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Shellsol A
- Substance type: hydrocarbon solvent (essentially C9 isomers, particularly trimethylbenzenes)
- Physical state: liquid
- Source: Shell Nederland Raffinarderij B.V. refinery, Pernis, Rotterdam, The Netherlands

Test animals

Species:
rat
Strain:
other: CD (COBS)
Sex:
male/female
Details on test animals and environmental conditions:
- Source: Charles River (UK) Ltd., Manston, Kent, UK
- Age at study initiation: 7-8 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet: ad libitum (except during exposure)
- Water: ad libitum (except during exposure)
- Acclimation period: no data

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: tubular glass chamber (2 rats/sex/chamber)
- Exposure chamber volume: no data
- System of generating atmosphere: Atmospheres generated dynamically by the near saturation of air supplied to the test chamber

TEST ATMOSPHERE
- Brief description of analytical method used: monitored continuously by means of a high temperature total hydrocarbon analyser (calibrated using a gravimetric procedure)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
10.2 mg/L
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
10 200 mg/m³ air
Exp. duration:
4 h
Remarks on result:
other: no mortalities at highest dose tested
Mortality:
no mortalities
Clinical signs:
lethargic behaviour

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute (4 hour) inhalation LC50 of Shellsol A to male and female rats was greater than 10,200 mg/m3 (10.2 mg/L)
Executive summary:
Rats were exposed for 4 hours to a near saturated atmosphere of Shellsol A (a mixture of trimethylbenzenes) at 10.2 mg/L. There were no deaths and no adverse signs other than lethargic behaviour; The acute LC50 was greater than 10,200 mg/m3.