Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report. Test item compostion unknown

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name of the test substance used in the study report: Scheckfarbstoff AS
The purity is stated as 100% of the drawn chemical structure in the order sheet. (Chemical structure is identical to the main component of the UVCB, CAS 6359-10-9)
The substance is stated to be a sales product.
The water solubility is indicated to be 20g/L. No information on pH is provided.
Specific details on test material used for the study:
Name of the test substance used in the study report: Scheckfarbstoff AS
Content: 100%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight: males 28.4 g, females 26.0 g
The animals were offered a standardized animal laboratory diet.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
0.5% aqueous CMC preparation
Form of application: suspension
Concentrations used: 2, 5.62, 7, 14.7 and 20% (w/v)
Doses:
200, 562, 700, 2470 and 2000 mg/kg
No. of animals per sex per dose:
5
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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 900 mg/kg bw
Mortality:
200 mg/kg: no deaths; 562 mg/kg: 1/5 males after 14 days; 700 mg/kg: 1/5 females and 2/5 males after 14 days; 1470 mg/kg: 4/5 females and 5/5 males after 14 days; 2000 mg/kg: all animals died within 24 hours
Clinical signs:
Protracted death, poor general state and weight loss; staggering, trembling, twitching, spastic gait, in some animals convulsions
Gross pathology:
Animals that died: intra-abdominal stain
Sacrificed animals: very fine intra-abdominal deposits of the test substance

Applicant's summary and conclusion