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Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: oral
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited documentation; original reference in Russian

Data source

Reference
Reference Type:
review article or handbook
Title:
Data to substantiate of the maximum permissible level of m-Trifluoromethylphenyl Isocyanate and Butyl Isocyanate in the air of work areas.
Author:
Gurova AI, Alekseeva NP, Gorlova OE, Chernyshova RA
Year:
1976
Bibliographic source:
Gig Tr Prof Zabol 3: 53-55, cited in Emergency Response Planning Guidelines Documentation (1994) n-Butylisocyanat. American Industrial Hygiene Association.

Materials and methods

Principles of method if other than guideline:
rats were given doses of 20%, 10%, or 5% of the LD50 (600 mg/kg) until a total dose corresponding to 4.5 times the LD50 was given
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: n-butyl isocyanate, no data on purity

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
until a total dose corresponding to 4.5 times the LD50 (600 mg/kg) was given
Frequency of treatment:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
5, 10 and 20 % of the LD50 (600 mg/kg)
Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
Post-exposure period: no data
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
no data

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No death occured, but functional accumulation described an increase in

neuromuscular excitation threshold was reported (no further information)

Applicant's summary and conclusion

Executive summary:

Method: rats were given doses of 20%, 10%, or 5% of the LD50 (600 mg/kg) until

a total dose corresponding to 4.5 times the LD50 was given

Result: No death occured, but functional accumulation described an increase

in neuromuscular excitation threshold was reported