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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7
Specific details on test material used for the study:
- Synonyms: Copper tri/tetrachlorophthalocyanine pigment
- Substance type: blue powder
- Analytical purity: >85%
- Lot/batch No.: M200058
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at approx. 20 °C in a fume cupboard
- Other: different CAS No. are existing: 29719-96-8, 68987-63-3, 16040-69-0, 27614-71-7

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 6-10 weeks
- Average weight at study initiation: males 189 g; females 178 g
- Fasting period before study: from ca. 16 h before to 3 - 4 h after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: ssniff (R) R/M-H (V 1534), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +- 3 °C
- Humidity: 50 +- 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
The animals received the compound as a 20 % suspension in sesame oil, the administration volume being 10 ml/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period, the animals were killed by CO2 asphyxilation, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality occurred
Mortality:
No deaths occured during the whole study.
Clinical signs:
Bluish discoloured feces were observed after the administration of the test material. From day 4 until the end of the study no findings were observed.
Body weight:
Development of body weight was not impaired, except one female, which suffered a loss of body weight between day 8 and day 15.
Gross pathology:
No macroscopically visible changes were seen.

Any other information on results incl. tables

Table 1: Individual body weights of rats

 

 

bodyweight (g) at day

animal no.

sex

1

8

15

1

f

176

196

220

2

f

176

199

207

3

f

178

207

216

4

f

180

200

207

5

f

178

216

203

1

m

187

263

294

2

m

189

261

298

3

m

191

259

295

4

m

182

228

268

5

m

197

258

286

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the limit test (accrding to OECD guideline 401) for acute toxicity after oral application, the LD50 for the test material is > 2000 mg/kg body weight for male and female rats.