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Description of key information

The determination of the acute oral toxicity of Reactive Red F-52 167 FW on Wistar-Rats revealed an LD50 of > 5000 mg/kg bw in male and female rats

The determination of the acute dermal Toxicity of Reactive Red F-52 167 FW in the Wistar-Rat revealed an LD50 of > 2000 mg/kg bw in male and female rats

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
84/449/EWG, B.1; OECD 401
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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: 194 g; females: 192 g
- Fasting period before study: NA
- Housing: 5/cage
- 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: 9.10.1986 To: 23.10.1986
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
25 % solutions in deioniesed water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle (if gavage): 2x10 mL/kg bw with a 30 min interval between both dosages

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs&death: frequently fisrt day; thereafter twice daily
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
As well as unspecific signs of intoxication the animals also exhibited diarrhoea. In addition, red discoloration of the hairless skin was observed. The substance was eliminated via the faeces and the urine, the urine still having a slight red colouration 14 days p.a.
Body weight:
The Bodyweight was not affected by the treatment
Gross pathology:
Post-mortem examination of the animals killed at the end of the experiment revealed a pink colouration of the connective and fatty tissue, of the pancreas, the bladder, the testes and the uterus.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Reactive Red F-52 167 FW has not to be classified, the LD50 is above 5000 mg/kg bw in male and female rats
Executive summary:

The determination of the acute oral toxicity of Reactive-Red F-52 167 FW on Wistar-Rats revelaed by males and females an LD50 of higher than 5000 mg/kg BW. After application of 5000 mg/kg BW there was no lethality observed.

The unspecific symptoms were mainly diarrhoea. Morever, a red coloration appeared on the abraded skin. After 14 days the urine was still redisch.

Also a red colouration was observed in the fatty tissue, pancreas, thymus, bladder and testicle (males) and uterus (females). The body weight developed normaly.

On base of the determination of the acute oral toxicity on male and female Wistar-Rats, is the Reactive Red F-52 167 FW has not to be classified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
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
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.
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.

.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The determination of the acute oral toxicity of Reactive-Red F-52 167 FW on Wistar-Rats revealed by males and females an LD50 of higher than 5000 mg/kg bw. After application of 5000 mg/kg bw there was no lethality observed.

The unspecific symptoms were mainly diarrhoea. Moreover, a red coloration appeared on the abraded skin. After 14 days the urine was still reddish.

A red colouration was observed in the fatty tissue, pancreas, thymus, bladder and testicle (males) and uterus (females). The body weight developed regular.

On base of the determination of the acute oral toxicity on male and female Wistar-Rats, is the Reactive Red F-52 167 FW has not to be classified.

 

 

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 lethality.

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, Reactive Red F-52 167 FW has not to be classified.

Justification for classification or non-classification