Registration Dossier

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1962

Materials and methods

Principles of method if other than guideline:
As described in Smyth, H.; Carpenter, C.; Well, C.; Pozzani, U.; Striegel, J., Range-Finding Toxicity Data, List VI American Industrial Hygiene Association Journal 23(2) 95-107 (1962)
GLP compliance:
no
Remarks:
presumably no accepted guideline existing at that time
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Test material form:
solid
Details on test material:
not reported
Specific details on test material used for the study:
no data available

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
4-5 weeks old, 90-120 / animal , Rockland rat diet, complete, reared in own premisees of Mellon Institute of Industrial Research, Pittsburgh

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
intubation
Doses:
logarithmic factor 2x
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
14 d observation period

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD0
Effect level:
>= 1 540 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no effect observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
no effect in rats, LC0 rat oral >= 1540 mg/kg bw (highest concentration tested)
Executive summary:

In a study of Smyth, H.; Carpenter, C.; Well, C.; Pozzani, U.; Striegel, J., Range-Finding Toxicity Data, List VI American Industrial Hygiene Association Journal 23(2) 95-107 (1962), no effect was observed in rats, yielding a LC0 rat oral >= 1540 mg/kg bw for the highest concentration tested