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Administrative data

Description of key information

The substance did not show signs of acute oral toxicity in rats in a GLP compliant study following OECD guideline 401.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.
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.

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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Valid without restriction

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral and dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.