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: Guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD TG 402 and EEC Directive 440/2008 Part B, Method B.3
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
black solid
content: 80.7%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation:
males 291-300 g
females 226-247 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%):55
- Air changes (per hr) 10:
- Photoperiod (hrs dark / hrs light): 12/12




Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was applied to a wet gauze layer which was then applied to the shaved area of the back of the rabbits. The patches were held in place by semi-occlusive dressing (gauze strip and a tape). After 24 hours the dressings were removed and the area was rinsed with tepid water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
other: the opposite site of the back of each animal served as control
Details on study design:
The test substance was applied to a wet gauze layer which was then applied to the shaved area of the back of the rabbits. The patches were held in place by semi-occlusive dressing (gauze strip and a tape). After 24 hours the dressings were removed and the area was rinsed with tepid water. The opposite site of the back of each animal served as control. Animals were observed for clinical signs and mortality for 14 days, weight gain was checked weekly. after termination of the observation period the animals were sacrificed and examind macroscopically
Statistics:
Only the limit dose was tested

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Remarks on result:
other: no death occurred and no clinical signs were reported
Mortality:
no animal died
Clinical signs:
no clinical sign is reported
Body weight:
no effect on weight development
Gross pathology:
no gross pathological f9nding

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

Nigrosin WLF was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semiocclusive conditions. After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw.