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Toxicological information

Acute Toxicity: oral

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
secondary source
Title:
C.I. Pigment Brown 24
Author:
OECD
Year:
2002
Bibliographic source:
SIDS Initial Assessment Report for SIAM 15

Materials and methods

Principles of method if other than guideline:
BASF test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 10 animals/sex was treated by single gavage with an aqueous suspension of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior to treatment only. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: 16 h
- Housing: Makrolon Typ III (maximum 5 animals per cage)
- Diet: standard pellet diet for mice and rats, ad libitum
- Water: ad libitum
- Acclimation period: 3-7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1
- Humidity (%): 55+/-10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5%

MAXIMUM DOSE VOLUME APPLIED: 31.6 mL/kg
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed within the first 15 min after application and 30 min, 1 h, 2 h, 4 h, 5 h, 24 h after application; subsequently at least once daily. Animals were weighed directly before the application.
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 10 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Nothing abnormal observed.
Body weight:
Normal weight gain.
Gross pathology:
Nothing abnormal observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met