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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Ro 1525 corresponds to Colipa A 155
Ro 1525
Batch No.: Ro 3962/88
SAT 020874

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred during the study.
Clinical signs:
No systemic signs of toxicity were observed during the study period.
Black discoloration produced by the test item was noted in four males and two females from test day 2 to 7 and persisted in one male and two
females up to test day 8 and in one female
up to test day 9.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
The median lethal dose of Ro 1525 after single dermal administration to rats of both Sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mglkg body weight

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information EU DSD and UN GHS Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of Ro 1525 after single dermal administration to rats of both Sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mglkg body weight.
Executive summary:

Five male and five female HanBrl: WlST (SPF) rats were treated with Ro 1525 at 2000 mg/kg bw dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.5 g/mL and administered at a volume dosage of 4 ml/kg. The application

period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15.

Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the Course of the study.

Black discoloration produced by the test item was noted in four males and two females from test day 2 to 7 and persisted in one male and two females up to test day 8 and in one female up to test day 9.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.