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Diss Factsheets

Administrative data

Description of key information

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
Study period:
March 26, 2002 - May 14, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted March 22, 1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
September 30, 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: HanBrl: Wist (SPF)
Remarks:
recognized by the international guidelines as a recommended test system
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd Biotechnology and Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age when treated: 8 weeks (males), 10 weeks (females)
- Weight prior to administration: 163 g (female #1), 154.2 g (female #2), 159.2 g (female #3), 242.4 g (male #4), 221.0g (male #5), 235.9 g (male #6)
- Fasting period before study: 18-20 hours (access to water was permitted)
- Housing: in groups of three per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Mutten/Switzerland).
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3433 rat maintenance diet, batch no. 119/01 (Provimi Kliba AG, CH-4303 KaiseraugsV Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): community tap-water, from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, ltingen.
- Acclimation period: under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Humidity (%): 30-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the light period)
Route of administration:
oral: gavage
Vehicle:
other: Purified water
Remarks:
deionised water which was processed and treated by the PURELAB Option-R unit. The vehicle was chosen after a non-GLP solubility trial (trial formulation excluded from the GLP statement of compliance)
Details on oral exposure:
VEHICLE: purified water
- Concentration in vehicle: 0.2g test item/ml vehicle
- Amount of vehicle (if gavage): 10 ml vehicle/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This trial formulation is excluded from the GLP statement of compliance.
- Lot/batch no. (if required): not detailed
- Purity: purified water

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight

DOSAGE PREPARATION (if unusual): The dose formulations were made shortly before each dosing occasion. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The formulations were prepared using first a glass stick and then a magnetic stirrer as homogenizer. Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit concentration of 2000 mg/kg bw

TREATMENT
The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for 18 to 20 hours (access to water was permitted). Food was provided again 3 hours after dosing.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Mortality / Viability: daily during acclimatization and twice daily during days 1-15
Body weights : on test days 1 (prior to administration), 8 and 15
Clinical signs: daily during acclimatizalion and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.

- Necropsy of survivors performed: yes
All animals were killed at the end of the obseruation period by an intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight) and discarded after macroscopic examinations were peformed. No organs or tissues were retained.

- Other examinations performed: -
Statistics:
No statistical analysis was perfomed.
Preliminary study:
Not performed
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were obserued during the course of the study.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Evolution of body weight (in grams):

Sex/dose

Animal No.

Day 1 (= day of treatment)

Day 8

Day 15

Female / 2000 mg/kg

1

163.0

183.0

198.5

2

154.2

176.3

188.1

3

159.2

175.8

177.4

Male /

2000 mg/kg

4

242.4

277.1

312.0

5

221.0

253.0

277.3

6

235.9

278.3

308.3
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50(rat) of Red RWa 4565 is > 2000 mg/kg bw in test performed according to OECD TG 423 and following GLP.
Executive summary:

The acute oral toxicity of Red RWa 4565 has been determined in the current study performed following OECD TG 423 according to GLP.

One group of three male and three female HanBrl: WIST (SPF) rats was treated with Red RWa 4565 by oral gavage administration at a dosage of 2000 mg/kg body weight.

The test item was diluted in vehicle (purified water) 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 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days I and 15. All animals were necropsied and examined macroscopically.

 

The following animals were treated at 2000 mg/kg bw and percentage of mortality was observed: males 0% and females 0%

 

All animals survived until the end of the study period.

No clinical signs were observed during the course of the study.

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

No macroscopic findings were recorded at necropsy.

The median lethal dose of Red RWa 4565 after single oral administration to rats of both sexes, observed over a period of 14 days is:

LD50(RAT): GREATER THAN 2000 MG/KG BODY WEIGHT

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Klimisch code 1

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 27, 2002 - May 14, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted February 24, 1987
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
July 31, 1992
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
other: HanBrl: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Females (if applicable) nulliparous and non-pregnant: no
- Age when treated: 8 weeks (males), 10 weeks (females)
- Weight when treated: males 247.6-263.9 g, females 168.5-188.3 g
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. lndividually in Makrolon type-S cages with standard softwood bedding ("Lignocel", Schill AG, CH- 4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat maintenance diet, batch no. 119/01 (Provimi Kliba AG, CH-4303 KaiseraugsV Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the light period)
Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
deionised water which was processed and treated by the PURELAB Option-R unit.
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24h after the application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 0.5 g test item /mL vehicle
- Constant volume or concentration used: yes

VEHICLE : purified water
- Amount(s) applied (volume or weight with unit): 4mL (vehicle + test item)/kg
- Concentration (if solution): 0.5 g test item /mL vehicle
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Mortality/viability: Daily during acclimatization and twice daily during days 1-15.

- Necropsy of survivors performed: yes
At the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically. Thereafter, they were discarded.

- Other examinations performed: clinical signs, body weights

Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during acclimatization and at approximalely 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
Statistics:
No statistical analysis was performed.
Preliminary study:
Not performed
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No deaths occurred during the study.
Clinical signs:
No systemic signs of toxicity were obserued during the study period.
Violet discoloration of the treated skin area produced by the test item was noted in all animals after removal of the dressing and persisted until the end of the observation period.
Test item residue was additionally noted until test day 8.
Body weight:
One female animal showed a loss of body weight (1.9 %) between treatment start and test day 8. lt recovered at the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose of Red RWa 4565 after single dermal administration to rats of both sexes, observed over a period of 14 days, is > 2000 mg/kg bw in test performed according to OECD TG 402 and following GLP.
Executive summary:

The acute dermal toxicity of Red RWa 4565 has been determined in the current study performed following OECD TG 402 according to GLP.

A group of five male and five female HanBrl: WIST (SPF) rats was treated with Red RWa 4565 at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.5 g/ml and administered at a volume of 4 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 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15.

Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days I and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the observation period.

Violet discoloration of the treated skin area produced by the test item was noted in all animals after removal of the dressing and persisted until the end of the observation period.

Test item residue was additionally noted until test day 8.

One female animal showed a loss of body weight (1.9 %) between treatment start and test day 8. lt recovered at the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

 

The median lethal dose of Red RWa 4565 after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): > 2000 mg/kg bw

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Klimisch code 1

Additional information

Justification for classification or non-classification

For each route of exposure, the LD50/LC50 is > threshold dose leading to classification according to CLP criteria.