Registration Dossier

Administrative data

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

Data source

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

Materials and methods

Test guidelineopen allclose all
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

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 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

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.