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Diss Factsheets

Administrative data

Description of key information

Oral LD50 (rat) > 2000 mg/kg bw
Dermal LD50 (rat) > 2000 mg/kg bw
Acute toxicity: Inhalation: waiver

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:
04 May - 31 Jul 2001
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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Füllinsdorf, Switzerland
- Age at study initiation: Males: 8 weeks, Females: 10 weeks
- Weight at study initiation: no data
- Fasting period before study: 16 - 20 hours
- Housing: In groups of 3 per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding (´Lignocel´ Schill AG, CH-4132 Muttenz/Switzerland).
- Diet: Pelleted standard Provimi Kliba 3422 rat maintenance diet, batch no. 07/00 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd., Itingen.
- Water: Community tap-water, from Itingen ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examinations. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light / 12 hours dark (light period between 6.00 and 18.00), music during the light period.

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw

Doses:
2000 mg/kg bw
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: daily during acclimatization and at least once daily during days 1 - 15. Bodyweights on days 1 (pre-administration), 8 and 15. Clinical signs daily during acclimatization and at least four times (target times: approximately one, two, three and five hours) on test day 1 after the administration, depending on the occurrence of clinical signs of toxicity. At least once daily during days 2 - 15, depending on the occurrence of clinical signs of toxicity.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occured during the study.
Clinical signs:
other: No clinical signs of toxicity were noted.
Gross pathology:
No macroscopic findings were observed.
Interpretation of results:
other: CLP criteria not met
Conclusions:
The median lethal dose of Y-15099 after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.
Executive summary:

In an acute oral toxicity GLP study according to OECD 423, one group of three male and three female HanBrl: WIST (SPF) rats was treated by oral gavage with Y-15099 at 2000 mg/kg body weight. The test item was applied undiluted in volume of 2 mL/kg bw. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2 – 15. Mortality and viability were recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and at least once daily on test days 2 – 15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. On day 15 all animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were evident 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 observed at necropsy.

The median lethal dose of Y-15099 after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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:
02 May - 06 Aug 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Devision, Füllinsdorf, Switzerland
- Age at study initiation: Males: 9 weeks; Females: 12 weeks
- Weight at study initiation: no data
- Housing: During acclimatization in groups of 5 per sex in Makrolon Type-4 cages with standard softwood bedding. Individually in Makrolon Type-3 cages with standard softwood bedding (´Lignocel´, Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet: Pelleted standard Kliba 3433, batch no. 07/00 rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water: Community tap water from Itingen, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/12 hours dark (light period between 6.00 and 18.00), music during the light period.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: backs of the animals
- % coverage: 10% of the body surface
- Type of wrap if used: wrap was fixed with elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL
- Constant volume or concentration used: yes


Duration of exposure:
24 hours
Doses:
2000 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
- Frequency of observations and weighing: daily during acclimatization and at least one, two, three and approximately 5 hours after the test item administration, depending on the occurence of clinical signs of toxicity. At least once daily during days 2 - 15, depending on the occurence of clinical signs of toxicity. Bodyweights on days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the study.
Clinical signs:
other: No clinical signs of toxicity were observed.
Gross pathology:
No macroscopic findings were observed.
Interpretation of results:
other: CLP criteria not met
Conclusions:
The median lethal dose of Y-15099 after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity GLP study according to OECD 402, groups of five male and five female Hanlbm: WIST (SPF) rats were treated with Y-15099 at 2000 mg/kg bw by dermal application under semi-occlusive conditions (Damme, 2001). The test item was applied undiluted as delivered from the sponsor at a volume of 2 mL/kg bw. The animals were examined for clinical signs four times during the test day 1 and once daily during test days 2 – 15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1. During test days 2 – 15 it was recorded two times a day. Body weights were recorded on day 1 prior to administration and on days 8 and 15. On day 15 all animals were euthanized and examined macroscopically. No deaths occurred during the study. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

The median lethal dose of Y-15099 after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

In an acute oral toxicity GLP study according to OECD 423, one group of three male and three female HanBrl:WIST (SPF) rats was treated by oral gavage with Y-15099 at 2000 mg/kg bw (Damme, 2001). The test item was applied undiluted in a volume of 2 mL/kg bw. The observation period was 15 days. All animals survived until the end of the study period. No clinical signs were evident 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 observed at necropsy. The acute oral LD50 was found to be greater than 2000 mg/kg bw.

 

Acute dermal toxicity: 

In an acute dermal toxicity GLP study according to OECD 402, groups of five male and five female Hanlbm:WIST (SPF) rats were treated with undiluted Y-15099 at 2000 mg/kg bw by dermal application under semi-occlusive conditions (Damme, 2001). The exposure duration was 24 hours. The animals were observed for 15 days. No deaths occurred during the study. No clinical signs of toxicity and no macroscopic pathological changes were observed. The acute dermal LD50 was found to be greater than 2000 mg/kg bw.

 

Acute inhalation toxicity:

According to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5.2, Column 2, testing by the inhalation route is appropriate if exposure of humans via inhalation is 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. The vapour pressure of the liquid substance is very low (0.002 Pa at 25 °C).Exposure to vapour can thus be precluded. Exposure to droplets is not given for the determined uses of the substance.

 

Justification for classification or non-classification

The inhalation route was judged to be a non-relevant route of exposure.

According to CLP (1272/2008/EC) classification criteria for acute toxicity, no classification is warranted.