Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
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:
1982
Report date:
1982
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
EC Number:
280-472-4
EC Name:
2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
Cas Number:
83524-75-8
Molecular formula:
C40H26N2O6
IUPAC Name:
7,18-bis[(4-methoxyphenyl)methyl]-7,18-diazaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(22),2,4,9,11,13(23),14,16(24),20,25-decaene-6,8,17,19-tetrone
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: About 12 weeks
- Weight at study initiation: 209 g (males) and 187 g (females)
- Fasting period before study: 16 hours before administration
- Housing: Type DK-111 stainless steel wire mesh cages (supplied by Becker L Co., Castrop-Rauxel, FRG), 5 animals/cage
- Diet (e.g. ad libitum): Ssniff R; supplied by Ssniff, Versuchstierdiäten, D-4470 Soest, FRG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Acclimatisation for at least one week in the animal care unit

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5%
Details on oral exposure:
- Concentration in vehicle: 25 % (w/v)
- Administration volume: 20 ml/kg
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
- Cage side observations: recording of signs several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once daily on weekends and public holidays.
- Body weights: beginning of the test, day 3, 7 and 13
- Necropsy of survivors performed: yes

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 observed
Mortality:
None of the animals died during the observation period.
Clinical signs:
Blue faeces at day 1 and 2.
Body weight:
Normal body weight gain.
Day 3, mean weight (g): males: 244; females 208
Day 7, mean weight (g): males: 262; females 216
Day 13, mean weight (g): males: 293; females 220.
Gross pathology:
No abnormal findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met