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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on purity, no individual pathologic data.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1992
Reference Type:
other: OECD SIDS
Title:
Unnamed
Year:
2001

Materials and methods

Principles of method if other than guideline:
2 rabbits/sex/dose, 5 doses, single dermal application (intact skin), undiluted (warmed to make suitable for dosing), no further information, exposure time: 24 hours, post-exposure observation time: 14 days.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data on purity.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: undiluted, warmed to make suitable for dosing
Details on dermal exposure:
TEST SITE
- Intact skin
REMOVAL OF TEST SUBSTANCE
- No data
TEST MATERIAL
- Undiluted, warmed to make suitable for dosing
Duration of exposure:
24 hours
Doses:
251, 316, 398, 501, 631 mg/kg bw
No. of animals per sex per dose:
2 rabbits/sex/dose
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
445 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
355 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
400 mg/kg bw
Based on:
test mat.
Mortality:
Males: 0, 0, 0, 2, and 2 animals died at 251, 316, 398, 501 and 631 mg/kg bw, respectively.
Females: 0, 1, 2, 1, and 2 animals died at 251, 316, 398, 501 and 631 mg/kg bw, respectively.
Time of death: no data.
Clinical signs:
Lethargy (lasting up to 3 days), increasing weakness, collapse.
Gross pathology:
Decedents: haemorrhagic areas of the lungs; discoloration of liver, kidney and spleen; enlarged gall bladder; gastrointestinal inflammation.
Survivors: viscera appeared normal.

Applicant's summary and conclusion