Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug. 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: standard
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 'Anthrazen reinst'
Product No. 110.147

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. A. Ivanovas, Kisslegg/Germany
- Age at study initiation:
- Weight at study initiation: 220 - 245 (m); 210 - 250 (f)
- Fasting period before study: approx. 16 h, new feed 4 h post-application
- Housing: single
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 7.5 cm
- skin shaved
- Type of wrap if used: aluminum foil covered with adhesive tape round the trunk


REMOVAL OF TEST SUBSTANCE
- Washing (if done): luke-warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1320 mg in 3.3 mL PEG/kg bw (maximum volume technically applicable)
- concentration in vehicle: approx. 25 % (w/v) (maximum amount technically applicable)
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 3.3 mL/kg bw
Duration of exposure:
24 h
Doses:
1320 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
not applicable

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 1 320 mg/kg bw
Mortality:
none
Clinical signs:
none, no systemic effects
Body weight:
normal
Gross pathology:
no particular findings
Other findings:
no local effects

Applicant's summary and conclusion