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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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