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Description of key information

The test substance is practically non-toxic.

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:
March 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; GLP compliant
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The outbred Sprague-Dawley Rat, weighing 200-300 grams and approximately 8 weeks of age, was used for this study.
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3. The rats were not used in any previous study and were acclimated to the laboratory for at least 5 days prior to dosing.
Rats were deprived of food but not water overnight prior to dosing.

The animals were randomized using a computer generated list of random numbers. They were individually identified by ear punch.
Each cage was identified with a cage card displaying the animal numbers, sex, project number, test article, date dosed, dose level and responsible technician's initials .

Husbandry Conditions:
Temperature - 72°F ~ 2°F
Relative Humidity - 45% ~ 5%
Light - 12 hour light/dark cycle
Diet - Wayne Lab-Blox and tap water were provided ad libitum .
Based on our current knowledge no contaminants were known to be in this diet or water that might be expected to interfere with the objectives of the study.

Caging - Stainless steel with elevated wire mesh flooring
3-5 rats/cage by sex

Bedding - Techboard
Shepherd Products Company
Kalamazoo, Michigan 49005
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The sample was dosed as a 25% w/v suspension in deionized water.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 females
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: clinical signs multiple times on day one, thereafter twice daily; body weight: weekly
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died at 5000 mg/kg
Clinical signs:
Within 3 hours the animals were prostrate and ruffled. They appeared recovered within 24 hours.
They continued to remain normal throughout the observation period.
Body weight:
Noe effects on body weight observed
Gross pathology:
Gross pathologic examination revealed nothing remarkable.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral lethal dose was tested to be > 5000 mg/kg bw in both male and female rats.
Executive summary:

The sample was dosed as a 25% w/v suspension in deionized water.

One group of ten (5 male & 5 female) albino rats was deprived of food but not water overnight prior to dosing.

The following dosage level was administered:

5.0 g/kg

Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon). Individual weights

were recorded on the day of dosage, weekly thereafter, and prior to sacrifice.

Gross autopsies were performed on all survivors of the 14 day observation period.

The subject material when studied in male and female albino rats has an acute oral LD50 greater than 5000 mg/kg.

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

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Due to the physico-chemical properties of the test item, and the information gained from ADME studies with Reactive Black 5, dermal penetration is most unlikely. Due to the good water solubility, the toxicologically most relevant route of exposure is the oral one. A single dose study with oral gavage of Reactive Blue 250 at a dose level of 5000 mg/kg body weight is available. This study showed that Reactive Blue 250 has a very low toxicity with an oral LD50 above the maximum applied dose of 5000 mg/kg body weight. This is confirmed by studies with the structural analogue Reactive Black 5 with oral LD50 values of above the maximum applied dose of 5000 mg/kg body weight in two studies with female rats or between 14000 and 14500 mg/kg body weight in a study with male and female rats.

Inhalative exposure of workers to Reactive Blue 250 is very unlikely, as production and spray drying is done in a closed process without isolation of reaction products. The isolated product are dust free granules or dedusted powders (non-dusty solid) therefore inhalative exposure of down-stream users is very unlikely, too.

Justification for classification or non-classification

No classification necessary.