Registration Dossier

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: Already evaluated by the Competent Authorities for Biocides and Existing Substance Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: MAFF 4200 (1985)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Lot/Batch number: Batch number 844, S
pecification: Not stated,
Description: Blue crystals,
Purity: 99.0 - 100.5%,
Stability: Reported to be stable under the conditions of the study.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Source: Iffa Credo, B.P. 0109 (L'Arbresle Cedex, France)
At test initiation:
Males were 5 to 7 weeks old in a body weight range of 226 -234 g.
Females were 5 to 7 weeks old in a body weight range of 216 - 217 g.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
Purified water
Details on dermal exposure:
Male and female rats were exposed at 2000 mg/kg by cutaneous application of the test material in a paste formulation to 10% of the body surface. Exposure was for 24 hours under a semi-occlusive bandage.
Vehicle: Purified water
Concentration in vehicle: 175.66%(w/v).
Duration of exposure:
24 hours
Doses:
2,000 mg/kg [concentration in vehicle 175.66% w/v]
No. of animals per sex per dose:
10 (5 male and 5 female)
Control animals:
no
Details on study design:
Duration of observation period : 14 days
Daily observations of mortality and clinical observations of cutaneous examinations were performed from day 2 to 15. All rats were necropsied on
day 15.
Statistics:
No details.

Results and discussion

Preliminary study:
No mortality or clinical signs were observed.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
No behavioural or clinical signs were observed in any of the treated animals during the observation period.
Body weight:
Bodyweights of male and female rats were not influenced by treatment.
Gross pathology:
No macroscopic findings were observed that were associated with treatment.
Other findings:
LD50 (male and female rats combined) >2,000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Under the conditions of the limit test. Criteria used for interpretation of results: EU
Conclusions:
LD50 (male and female rats combined) >2000 mg/kg
Executive summary:

Materials and Methods

Male and female rats were exposed at 2000 mg/kg by cutaneous application of the test material in a paste formulation to 10% of the body surface. Exposure was for 24 hours under a semi-occlusive bandage. Clinical signs were observed over 14 days post-dose and all animals were subjected to necropsy at day 15.

Results and Discussion

No mortality was observed.

No behavioural or clinical signs were observed in any of the treated animals during the observation period.

LD50 (male and female rats combined) >2000 mg/kg.

Conclusion

LD50(male and female rats combined) >2,000 mg/kg.