Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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:
In an acute dermal toxicity study, the test material was applied to the skin of rabbits at two doses, and animals assessed for toxic symptoms.
GLP compliance:
not specified
Test type:
other:
Limit test:
no

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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2-2.5 kg
no further data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
5.01 and 7.94 g/kg bw
No. of animals per sex per dose:
One male was tested at 5.01 g/kg bw, and one male and one female at 7.94 g/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- 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:
> 7 940 mg/kg bw
Remarks on result:
other: No deaths at 7.94 g/kg bw
Mortality:
All three animals survived the 14-day observation period
Clinical signs:
Reduced appetite and activity seen for one to three days (number of animals and doses not given)
Body weight:
no data
Gross pathology:
The viscera appeared normal following macroscopic examination

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
There were no deaths when three rabbits (mixed sex) were given a 24-hour skin application of undiluted Santicizer 261 at up to 7.94 g/kg bw and then observed for two weeks.
Executive summary:

Undiluted Santicizer 261 was applied to the skin of a total of three New Zealand white rabbits. One male was dosed at each of 5.01 and 7.94 g/kg bw, and one female dosed at 7.94 g/kg bw, for an exposure period of 24 hours. The animals were assessed for toxic symptoms during the observation period, and the surviving animals sacrificed 14 days after dosing and examined macroscopically.

 

All three animals survived the 14-day observation period. Reduced appetite and activity was seen for one to three days (no details on number of animals or doses given). At necropsy, the viscera appeared normal. The investigators concluded that the LD50 was greater than 7.94 g/kg bw. Under the EU CLP regulations, this study would indicate that Santicizer 261 is not classified for acute dermal toxicity.