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Toxicological information

Acute Toxicity: inhalation

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP near guideline study available as unpublished report (in German) but otherwise fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Nominal: 7, 31.6, 52.2, 78.3, 104.4 mg/L
Analysed: 6.08, 20.00, 23.98, 38.87, 61.80 mg/L
No. of animals per sex per dose:
10
Control animals:
no
Statistics:
Probit analysis based on Finney (1971)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
28.1 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: 5/20 mortalities at 23.98 and 18/20 mortalities at 38.87 mg/L
Sex:
male
Dose descriptor:
LC50
Effect level:
25.7 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: 3/10 mortalities at 23.98 and 10/10 at 38.87 mg/L
Sex:
female
Dose descriptor:
LC50
Effect level:
30 mg/L air (analytical)
95% CL:
25.5 - 36.8
Exp. duration:
4 h
Remarks on result:
other: 2/10 mortalities at 23.98 and 8/10 mortalities at 38.87 mg/L
Mortality:
Mortality at 6.08, 20.00, 23.98, 38.87, 61.80 mg/L
Males: 0/10, 1/10, 3/10, 10/10, 10/10
Females: 0/10, 1/10, 2/10, 8/10, 10/10
Clinical signs:
Animals showed watery discharge from eyes and nose, unrest, increased respiration, rocking gait, narcosis, startling movements and hyperaemia of the ears and extremities. In the highest exposure group, salivation was observed. In the group exposed to 6.08 mg/L of toluene, no adverse clinical signs were observed. All surviving rats appeared normal after 3 days following the exposure.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute inhalation LC50 > 20 mg/L
Executive summary:

Acute inhalation toxicity of toluene was investigated in 5 groups of 10 male and female rats exposed for 4 hours at concentrations of 6.08, 20.00, 23.98, 38.87 or 61.80 mg/L.

Adverse clinical signs and mortality were seen at concentrations of 20 mg/L and above. All surviving animals were normal by day 3. The LC50 exceeded 20 mg/L (25.7 mg/L in males, 30 mg/L in females).

Toluene does not warrant classification under Dir 67/548/EEC or GHS.