Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only available as a brief summary report

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A total of five rats were administered the test material orally at one high dose and assessed for toxic symptoms.
GLP compliance:
not specified
Test type:
other: Single dose acute oral study
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Santicizer 261
- Lot/batch No.: DE 114
no further data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Average of 215 g for males and 225 g for females
no further data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
15.8 g/kg bw
No. of animals per sex per dose:
2 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic evaluation

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Remarks on result:
other: No deaths seen at 15.8 g/kg bw
Clinical signs:
Reduced appetite and and activity seen on days one and two after dosing.
Gross pathology:
Viscera appeared normal

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No deaths were seen in five rats (mixed sex) given a single oral administration of undiluted Santicizer 261 at 15.8 g/kg bw.
Executive summary:

Undiluted Santicizer 261 was orally administered to two male and three female Sprague-Dawley rats at 15.8 g/kg bw. The animals were assessed for toxic symptoms, and the survivors sacrificed 14 days after dosing and examined macroscopically.

All five animals survived the 14-day observation period. Reduced appetite and activity were seen for one to two days (numbers of animals not given). At necropsy, the viscera of all animals appeared normal. The investigators concluded that the LD50 was greater than 15.8 g/kg bw. Under the EU CLP regulations, this study would indicate that Santicizer 261 is not classified for acute oral toxicity.