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Toxicological information

Acute Toxicity: dermal

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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 brief summary data and results table available.

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 one of three doses, and animals assessed for toxic symptoms.
GLP compliance:
no
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 160
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: QE-29401

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0-2.2 kg

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No data
Duration of exposure:
24 hours
Doses:
3.98, 6.31 and 10.0 g/kg bw
No. of animals per sex per dose:
One male was tested at 3.98 g/kg bw, one female at 6.31 g/kg bw, and one male and one female at 10.0 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
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
All four animals survived the 14-day observation period
Clinical signs:
Reduced appetite and activity seen for two to four days (number of animals and doses not given)
Body weight:
no data
Gross pathology:
The viscera of the survivors appeared normal following macroscopic examination

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no deaths when four rabbits (2/sex) were given a 24-hour skin application of undiluted Santicizer 160 at up to 10.0 g/kg bw and then observed for 2 weeks. Although details of the study are only available in a brief summary report (hence it has been assigned reliability code 4), the data are considered adequate for assessment.
Executive summary:

Undiluted Santicizer 160 was applied to the skin of four New Zealand white rabbits. One male was dosed at each of 3.98 and 10.0 g/kg bw, and one female dosed at each of 6.31 and 10.0 g/kg bw, for an exposure period of 24 hours (no further details given on exposure conditions). The animals were assessed for toxic symptoms during the observation period, and the animals were sacrificed 14 days after dosing and examined macroscopically.

 

All four animals survived the 14-day observation period. Reductions in appetite and activity were seen for 2 -4 days (no details provided on the doses at which these effects were seen). At necropsy, the viscera appeared normal. The investigators concluded that the LD50 was greater than 10.0 g/kg bw. Under the EU CLP regulations, this study would indicate that Santicizer 160 should not be classified for acute dermal toxicity.