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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not performed under GLP conditions, used methods and results are preliminary documented.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
not mentioned.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
Name of test material (as cited in study report): Santowhite Crystals.

Test animals

Species:
rabbit
Strain:
other: New Zealand
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
corn oil
Details on dermal exposure:
substance applied as a 40% solution-suspension in corn oil
Duration of exposure:
24 hours
Doses:
3160, 5010, 7940 mg/kg bw
No. of animals per sex per dose:
low: 1
middle: 2
high: 1
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 010 mg/kg bw
Clinical signs:
Reduced appetite and activity (three to seven days in survivors), increasing weakness, collapse, and death.
Gross pathology:
Lung hyperemia, liver discoloration, enlarged gall bladder, discoloration of spleen and kidneys, and gastrointestinal inflammation.
Other findings:
survivors (14 days): congestion of lungsand slight liver and kidney discoloration

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A study in albino male and female rabbits suggested that Santowhite crystals were toxic upon dermal administration. The dermal LD50 was placed at > 5010 mg/kg bw. The study was not performed according to the general guidelines for acute dermal toxicity testing under GLP conditions and poorly documented, since it dates from 1973. Nevertheless the data give an indication of acute toxicity upon dermal administration to rats.