Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Testing performed in 1967

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
The testing pre-dates OECD, but is broadly similar.
Deviations:
yes
Remarks:
A single (very high) dose was used.
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Neat material

Test animals

Species:
rat
Strain:
other: C.F.E.
Sex:
male/female
Details on test animals and environmental conditions:
Weight range 91 g to 128 g, starved for 20 hour prior and 4 hour after.

Administration / exposure

Route of administration:
oral: gavage
Doses:
A total of 100 ml/kg (183 000 mg/kg) in five doses over six hours.
No. of animals per sex per dose:
5 male, 5 female
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 100 mL/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
None specified.
Body weight:
No effect.
Gross pathology:
"Terminal autopsy failed to reveal any gross effects which could be attributed to treatment with test compounds"

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
"According to Gleason, Gosselin and Hodge (1963), the two compounds may be categorised as "practically non-toxic"."
Executive summary:

The material is non-toxic.