Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
84/449/EWG, B.3; OECD 402
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
see below

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 178 g; females: 184 g
- Fasting period before study: NA
- Housing: single
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25.11.1987 To: 9.12.1987

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Remarks:
0.9% NaCl solution in the proportion of 1 g + 1 ml to form a paste
Details on dermal exposure:
Area: 30 cm²

Duration of exposure:
24 h
Doses:
2000 mg/kg BW
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signsand mortality: frequently first day; twice daily thereafter
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
no sytemic clinical signs were observed
Body weight:
body weight development of the animals was normal.
Gross pathology:
No effects observed
Other findings:
Blue or red to purple discolored skin up to 6 days after test substance application

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute dermal LD50 male/female is greater than 2000 mg/kg.
Executive summary:

Die Prüfung der akuten dermalen Toxizität von Reaktiv Blau F-64 357 FW an der Wistar-Ratte ergab bei männlichen und weiblichen Tieren eine Dosis letalis media (LD50) über 2000 mg/kg Körpergewicht. Nach Applikation von 2000 mg/kg Kgw. traten

keine Todesfälle auf.

Während der gesamten Versuchszeit traten keinerlei Vergiftungssymptome auf. Die behandelte Hautfläche war bis zum 6. Tag p.a. blau bzw. rot bis lila verfärbt.

Die Sektion der nach Versuchsende getöteten Tiere ergab keine makroskopisch sichtbaren Besonderheiten.

Die Körpergewichtsentwicklung war nicht beeinträchtigt.

Aufgrund der akuten dermalen Toxizitätsprüfung an der männlichen und weiblichen Wistar-Ratte ist Reaktiv Blau F-64 357 FW nach den Einstufungskriterien der Richtlinie 83/467/EWG und der Gefahrstoffverordnung nicht kennzeichnungspflichtig.