[No public or meaningful name is available]

Endpoint summary

Description of key information

In an OECD 423 study the LD50 oral (female rat) is greater than 2000 mg/kg body weight.

 

The acute inhalation toxicity study has been waived as exposure via this route is unlikely.

 

In an OECD 402 study the LD50 dermal (rat) was determined to be greater than 2000 mg/kg body weight.

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:

8 September 2006 to 1 November 2006

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

Test system
Number of animals per group: 3 females
Total number of animals: 6 females
Age when treated: 11 weeks
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Environmental conditions
Conditions: Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Accommodation: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.

Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum.

Water: Community tap water from Füllinsdorf ad libitum.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Animals were fasted for approximately 17 hours after dosing (access to water was
permitted). Food was provided again approximately 3 hours after dosing.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

2 groups of 3 females were dosed

Details on study design:

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.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Hunched posture was noted in all animals at the 3-hour reading and persisted in three animals until the 5-hour reading.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

In an OECD 423 study the LD50 (female rat) is greater than 2000 mg/kg body weight.

Executive summary:

Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with the test substance by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was applied undiluted at a concentration of 0.95 g/mL and administered at a dosing volume of 2.11 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.

Hunched posture was noted in all animals at the 3-hour reading and persisted in three animals until the 5-hour reading.

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 LD50 (female rat) 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

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

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:

8 September 2006 to 14 November 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system
Number of animals per group: 5 males and 5 females
Total number of animals: 5 males and 5 females
Age when treated:
Males - 8 weeks
Females - 11 weeks
Identification: By unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Environmental conditions
Conditions: Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Accommodation: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.

Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum.

Water Community tap water from Füllinsdorf ad libitum.

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before treatment, the backs of the animals were clipped with an electric clipper,
exposing an area of approximately 10 % of the total body surface.

Only those animals without injury or irritation on the skin were used in the test.

On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the
intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was
wrapped around the abdomen and fixed with an elastic adhesive bandage.

Application volume/kg body weight: 2.11 mL

Duration of exposure:

Twenty-four hours after the application the dressing was removed and the skin was flushed
with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction
sites were assessed.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 females / 5 males

Details on study design:

Observations:
Mortality / Viability Daily during the acclimatization period, during the first 30 minutes and at approximately 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: On test days 1 (prior to administration), 8 and 15.

Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
Local signs Once daily during days 2-15. All abnormalities were recorded.

Necropsy:
All animals were killed at the end of the observation period by Carbon dioxide asphyxiation
and discarded after macroscopic examinations were performed. No organs or tissues were
retained.

Statistics:

No statistical analysis was used.

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Slight erythema was observed in all animals on test day 2 and persisted in three males and three females until test day 3, 4 or 7, respectively. Scaling was noted, in three females on test day 4 and persisted in two animals until test day 7, and in three

Gross pathology:

No macroscopic findings were observed at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

In an OECD 402 study the LD50 (rat) was determined to be greater than 2000 mg/kg body weight.

Executive summary:

Five male and five female HanRcc:WIST (SPF) rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was applied undiluted as delivered from the sponsor at a volume dosage of 2.11 mL/kg. The application period was 24 hours.

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. Local signs were noted once daily from test day 2 to 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.

No deaths occurred during the study.

Slight erythema was observed in all animals on test day 2 and persisted in three males and three females until test day 3, 4 or 7, respectively. Scaling was noted, in three females on test day 4 and persisted in two animals until test day 7, and in three males from test day 4 to 7 persisting in two animals until test day 10 and 11, respectively. Slight crusts were noted in one animal from test day 8 to 10.

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 LD50 (rat) was determined to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Justification for classification or non-classification

The test substance is not classified as acutely toxic via the oral or dermal routes of exposure.