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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1989

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
Details on test material:
Reactive Red 239

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 8 weeks; females: ca 9 weeks
- Weight at study initiation: mean: males: 223 g; females: 203 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: 14.10.1986 To: 28.10.1986

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Remarks:
0.9% NaCl solution in the proportion of 1 g + 0.7 ml
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

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:
Effects on organs:
The macroscopically determined findings among the animals killed at the end of the test revealed red discoloration of the connective and fatty tissue among 2 animals. The remaining animals were free from macroscopically visible peculiarities.
Other findings:
Signs of toxicity (local): There was no lethality at the examined dose of 2000 mg/kg body weight. The visible areas of skin of some animals were discoloured red during the first week of testing. In addition, isolated cases of small wounds with scabs occurred in the region of the shorn area of skin in the female animals. The findings were reversible 9 days p.a. The remaining animals were free from macroscopically visible peculiarities.

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:

The determination of the acute dermal toxicity of Reactive Red F-52 167 FW in the Wistar-Rat revealed for males and females an LD50 higher than 2000 mg/kg bw. After application of 2000 mg/kg BW there was no letality.

After application of the test substance on the visible part of the skin, some animals showed redness from day 2 to 7. Development of body weight was regular. The macroscopically determined findings among the animals killed at the end of the test revealed red discoloration of the connective and fatty tissue among 2 animals. The remaining animals were free from macroscopically visible peculiarities.

On the base of the determination of acute dermal toxicity in males and females Wistar-Rat, Reactiv Red F-52 167 FW has not to be classified.

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