Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: data obtained after Article 25(3) request
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Black 173 - Similar Substance 01
IUPAC Name:
Acid Black 173 - Similar Substance 01
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Wistar Bor:WISW (SPFCpb)
Sex:
male/female

Administration / exposure

Route of administration:
other:
Vehicle:
water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No symptoms of poisoning were observed in either of the sexes. No mortalities occurred. A slight reduction in body weight was determined for one female animal in the second week. The body weight development among all of the males and the remaining female rats was not influenced.
Gross pathology:
None

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

Method

The substance has been tested according to the EU method B.1.

Results

LD50 > 2000 mg/kg bw