Registration Dossier

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 OECD guideline or GLP defined, acceptable restrictions (incomplete documentation).
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
other: single dermal application of undiluted test substance for 24 hours, fixed with a dressing, observation time: 14 d
GLP compliance:
not specified
Test type:
other: Acute dermal toxicity study in rats
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: Benzylamine

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann
- Weight at study initiation: 160 - 180 g

Administration / exposure

Type of coverage:
other: dressing (no further details)
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
1.00, 1.25, 1.30, 1.50, 2.50, 5.00 g/kg bw
No. of animals per sex per dose:
1.0 g/kg bw = 10 animals/sex/dose
1.25 g/kg bw =10 animals/sex/dose
1.30 g/kg bw =10 animals/sex/dose (only male animals!)
1.50 g/kg bw =10 animals/sex/dose
2.50 g/kg bw =10 animals/sex/dose
5.00 g/kg bw = 5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
Statistics:
LD50 calculation according to Fink and Hund.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1.35 other: g/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
1.34 other: g/kg bw
Based on:
test mat.
Mortality:
5.00 g/kg bw: 5/5 males and 5/5 females;
2.50 g/kg bw: 10/10 males and 10/10 females;
1.50 g/kg bw: 10/10 males and 9/10 females;
1.30 g/kg bw: 3/10 males;
1.25 g/kg bw: 0/10 males and 2/10 females;
1.00 g/kg bw: 0/10 males and 0/10 females
Clinical signs:
All animals showed clinical signs after the treatment with the test substance.

Applicant's summary and conclusion