Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (mostly due to reduced reporting in times before GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
The application volume was not calculated by the individual weight, but by the mean weight per sex
Principles of method if other than guideline:
Standardized test method (BASF-Test)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pigmentorange Kan 78/1775
- Test substance number: 80/404
- Physical state: solid, orange
- Analytical purity: > 98 %
- Lot/batch No.: Batch 8

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: about 12 weeks
- Mean weight at study initiation: males 170 g, females 180 g
- Fasting period before study: 16 hours
- Housing: 5 animals per cage; Type DK-Ill stainless steel wire mesh cages (Becker & Co., Castrop-Rauxel, Germany)
- Diet: Herilan, mouse/rat/hamster maintenance diet; H. Eggersmann KG, Rinteln, Germany, ad libitum
- Water: Fully demineralized water each workday ad libitum; on holidays tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % aqueous carboxymethyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 31.6 % (w/v)
- Amount of vehicle (if gavage): 2.69 mL/male; 2.84 mL/female
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium

MAXIMUM DOSE VOLUME APPLIED: 15.8 mL/kg bw

DOSAGE PREPARATION (if unusual):
- Form of administration: Suspension

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs < 15, 15 and 30 minutes, 1 h, 2 h, 4 h and 5 h after administration of test substance and then once each workday. Check for moribund and dead animals twice each workday and once on weekends and public holidays.
- Frequency of weighing: Animals of comparable weights (± 10 g) in one cage. Group weighing before administration, 2nd weighing on days 2 - 4, 3rd weighing on day 7, 4th weighing on day 13 after administration.
- Necropsy of survivors performed: yes, withdrawal of feed 16 hours before sacrifice with CO2, then necropsy with gross-pathological
assessment. All animals that died are necropsied as early as possible.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality.
Mortality:
No mortality detected (0/10 animals).
Clinical signs:
No abnormalities detected.
Body weight:
No abnormalities in body weight gain detected.
mean body weight:
- day 0: males: 170 g, females: 180 g;
- day 2-4: males: 194 g, females: 201 g;
- day 7: males: 240 g, females: 224 g;
- day 13: males: 268 g, females: 231 g.
Gross pathology:
No abnormalities in sacrificed animals detected.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information