Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Range finder study only, but done to good standards and GLP

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Trade name 2076 BENZANIL RUBINE 2BL
Purity: 55-60%
Specific details on test material used for the study:
The substance tested was reported as the trade name Benzanil Rubine 2BL which is Direct Red 83-1. Purity was cited at 55-60% (impurities sodium chloride and water). Although dose levels do not appear to have been adjusted for purity, the absence of findings at 2000 mg/kg means that even if adjusting for purity, the disciminating dose is > 1000 mg/kg and classification is not needed. No further animal testing is justified.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Range-finding study
Dose level: 2000 mg/kg bw, one male and one female

Main study
Dose level: 2000 mg/kg bw, 5 males and 5 females
Control animals:
no
Details on study design:
Procedure
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Range-finding study
The animals were observed for deaths or overt signs of toxicity, ½, 1, 2 and 4 hr after dosing and subsequently once daily for 5 days.

Main study
The animals were observed for deaths or overt signs of toxicity, ½, 1, 2 and 4 hr after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Preliminary study:
Range-finding study
There were no deaths or clinical signs of toxicity.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths after 14 days.
Clinical signs:
Noisy respiration was noted in one female up to two hours after treatment. Red stained faeces was noted in one female four hours after treatment and in all animal at the Day 1 observation. Red stained fur was commonly noted in the females at the 4 hours and Day 1 observations and persisted in one female up to the Day 4 observation.
No other clinical signs of toxicity were noted.
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material, 2076 BENZANIL RUBINE 2BL, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bw.
Executive summary:

The substance tested was reported as the trade name Benzanil Rubine 2BL which is Direct Red 83-1.  Purity was cited at 55-60% (impurities sodium chloride and water).  Although dose levels do not appear to have been adjusted for purity, the absence of findings at 2000 mg/kg means that even if adjusting for purity, the disciminating dose is > 1000 mg/kg and classification is not needed. No further animal testing is justified.