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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 February 1995 to 01 March 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recent EU test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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:
- Name of test material (as cited in study report): Reactive Blue FC 75311

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winklemann, Borchen, Germany
- Age at study initiation: Males 6 -7 weeks, Females 8 - 9 weeks
- Weight at study initiation: Initial mean weight: Males 180g, Females 161g
- Fasting period before study: 16 hours prior
- Housing: Conventational conditions - Makrolon Typo-III cages, 5 to a cage
- Diet (e.g. ad libitum): Altromin 1324 pellets, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark (artifical light from 6am to 6pm)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Demineralised
Details on oral exposure:
As above; the substance was administered as a single dose of 2000 mg/kg in demineralised water.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Males 5
Females 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Several times on day of administration, twice daily during the observation period (once on weekends & bank holidays)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the 14-day observation period.
Clinical signs:
Blue discoloration of the feces in correspondence with the color of the dye was observed after single administration of 2000 mg/kg from four hours until the 3rd day following treatment. No other signs of intoxication occurred. All animals were free of signs from the 4th day.
Body weight:
Growth of male and female rats was not affected
Gross pathology:
None of the animals sacrificed at the end of the 14-day observation period showed any noticeable gross pathological findings.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the present investigations, the test substance is therefore to be regarded as relatively non-toxic.

LD50 > 2000 mg/kg body weight.
Executive summary:

Study conducted to recent EU & OECD test guidance in compliance with GLP.

Based on the present investigations, the test substance is regarded as relatively non-toxic and is not classified.

LD50 > 2000 mg/kg body weight.