Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VIII.
Author:
Carpenter C.P, Weil C.S & Smyth H.F.
Year:
1974
Bibliographic source:
Toxicology and Applied Pharmacology 28(2): 313-9.
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List V.
Author:
Smyth H.F, Carpenter C.P, Weil C.S & Pozzani U.C
Year:
1954
Bibliographic source:
Arch. Ind. Hyg. Occup. Med.10, 61-68

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single oral dose toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, four to five weeks of age and 90 to 120 grams in weight which have been reared in the laboratory own colony and maintained from time of weaning on Rockland rat diet, complete. The dosages were arranged in a logarithmic series differing by a factor of two. Whenever possible, the chemical was administered undiluted. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson using the tables of Weil.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellon Institute of Industrial Research, Pennsylvania, USA.
- Age at study initiation: 4-5 weeks.
- Weight at study initiation: 90-120 g (males)
- Diet : Maintained from time of weaning on Rockland rat diet, complete.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
No details given
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
No data
Statistics:
No data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 802 mg/kg bw
Based on:
test mat.
Mortality:
No data
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data

Any other information on results incl. tables

The LD50 of 2.83 ml/kg bw (2.05 - 3.89 ml/kg bw) was converted using a specific density of 0.99 g/cm³.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The very limited details given in the secondary source indicate the test substance to be of relatively low toxicity via the oral route.