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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation:animlas of comparable weight (+/- 20% of the mean weight)
- Fasting period before study: 16 hours before administration
- Housing: single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: al least 5 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in both 2000 mg/kg bw test group.
Clinical signs:
Clinical signs in the first 2000 mg/kg bw test group revealed in all animals impaired general state and piloerection from hour 3 until hour 5 and black discolored feces on study day 1 after administration.
Clinical signs in the second 2000 mg/kg bw test group revealed in all animals impaired general state and piloerection at hour 3 and hour 4, which persisted in two animals until hour 5, while black discolored feces was seen in all animals on study day 1 after administration.
Body weight:
The body weight of the surviving animals in both 2000 mg/kg bw test groups increased within the normal range throughout the study period with one exception in the first test group. The body weight of one animal increased within the normal range during the first week, but stagnated during the second week.
This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
Gross pathology:
The following macroscopic pathologic findings were observed in the surviving animals sacrificed at the end of the observation period: Black discoloration of both kidneys in all animals in both test groups

Any other information on results incl. tables

Mortality

Dose (mg/kg bw):

2000

2000

Sex:

female

female

Administration:

1

2

No. of animals

3

3

Mortality (animals)

No mortality

No mortality

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose of Direct Black 18L NA active dye after oral administration was found to be greater than 2000 mg/kg bw in rats.