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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
Study period:
22 June 2005 to 11 August 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study meets or exceeds requirements of OECD Guideline 423 and EU Method B.1 tris

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Study in compliance with Swiss Ordinance relating to GLP, which is based on OECD Principles of GLP
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain specifics: HanRcc:WIST (SPF)
- Source: RCC Ltd, Laboratory Animal services, Füllinsdorf, Switzerland
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 173.8-192.2 g on day 1 (treatment)
- Fasting period before study: approximately 18 hours before treatment, access to water permitted)
- Housing: in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): standard rat/mouse maintenance diet, ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg body weight (volume of test item in vehicle)
- Justification for choice of vehicle: solubility trial before the study initiation date (excluded from GLP statement of compliance)
- Vehicle Lot/batch no. (if required): 1107712 24104041
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days starting with treatment day 1
- Frequency of observations and weighing:
mortality/viability: during the first 30 minutes and approximately 1, 2, 3 and 5 h after administration on day 1 and twice daily on days 2-15
clinical signs: during the first 30 minutes and approximately 1, 2, 3 and 5 h after administration on day 1 and daily on days 2-15
body weights: on days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Statistics:
None

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths
Clinical signs:
Red faeces in all animals from test day 2 to 5 (3 animals) or 6 (3 animals), slightly ruffled fur in 3/6 animals from 30 minutes until 2, 3 or 5 hours (different duration in each of the affected animals) after treatment on day 1.
Body weight:
Body weights were within the range commonly recorded for this strain and age.
Gross pathology:
Congestion of the lungs in one animal, but no macroscopic findings in the remaining five animals at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The median lethal dose (LD50) of test item (Pigment Red 122) after a single oral administration to female rats, observed over a period of 14 days, was greater than 2000 mg/kg body weight. The test item has not to be classified as acutely toxic by the oral route according to Regulation (EC) No 1272/2008.
Executive summary:

Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with the test item (Pigment Red 122) by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mL/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period.

Red feces were observed in all animals from test day 2 to 5 or test day 6. Three out of 6 animals were noted with slightly ruffled fur from the observation performed within the first 30 minutes after application to the 2-, 3- or 5 -hour reading.

The body weight of the animals was within the range commonly recorded for this strain and age.

Congestion of the lungs was noted in one animal whereas no macroscopic findings were recorded in the remaining five animals at scheduled necropsy.

The median lethal dose of the test item after single oral administration to female rats, observed over a period of 14 days is:

LD50 (female rat): greater than 2000 mg/kg body weight

Therefore, the test item has not to be classified as acutely toxic by the oral route according to Regulation (EC) No 1272/2008.